qanastek/EMEA-V3 huggingface dataset:
The import, sale, supply and/ or use of VIRBAGEN OMEGA is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
L- importazzjoni, il- bejgħ, il- forniment u/ jew l- użu ta 'VIRBAGEN OMEGA huma, jew jistgħu jiġu pprojbiti f' ċerti Stati Membri fuq it- territorju kollu jew parti minnu, skond il- politika tas- saħħa nazzjonali ta' l- annimali.
Any person intending to import, sell, supply and/ or use VIRBAGEN OMEGA must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Kwalunkwe persuna li għandha l- intenzjoni li timporta, tbigħ, tforni u/ jew tuża VIRBAGEN OMEGA trid tkellem lill- awtorità kompetenti ta 'l- Istat Membru rilevanti dwar il - politika dwar it- tilqim kurrenti, qabel l- importazzjoni, bejgħ, forniment u/ jew użu.
6/ 31 ANNEX II
6/ 31 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U SID/ SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL - ĦRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L - AWTORIZZAZZJONI TAL- KUMMERĊ FUQ IL- PROVVISTA JEW L- UŻU
2-1 Nihonbashi -muromachi 2-chome Chuo-ku, Tokyo 103, Japan
2- 1 Nihonbashi - muromachi 2- chome Chuo- ku, Tokyo 103, Ġappun
To be supplied only on veterinary prescription.
Sabiex jingħataw biss bi preskrizzjoni veterinarja.
According to Article 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council as amended, Member States prohibit or may prohibit the import, sale, supply and/ or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Skond Artiklu 71 ta 'Direttiva 2001/ 82/ KE tal- Parlament Ewropew u tal- Kunsill kif emendat, l- Istati Membri jipprojbixxu jew jistgħu jipprojbixxu l- importazzjoni, il- bejgħ, il- forniment u/ jew l- użu tal - prodott mediċinali veterinarju fuq it- territorju kollu jew parti minnu jekk ikun stabbilit li:
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
a) l- għoti tal- prodott mediċinali veterinarju lill- annimali ser jinterferixxi ma 'l- implimentazzjoni ta' programmi nazzjonali għad- dijanjosi, il- kontroll u l- qerda ta 'mard ta' l- annimali, jew ser jikkawża diffikultajiet fiċ- ċertifikazzjoni l- assenza ta 'kontaminazzjoni f' annimali ħajjin jew fl - għalf jew fi prodotti oħra miksuba minn annimali kkurati.
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
b) il- marda li għaliha l- prodott mediċinali veterinarju kien intenzjonat li jagħti immunità minnha, tkun kważi nieqsa għal kollox mit- territorju.
SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING AUTHORISATION HOLDER
OBBLIGAZZJONIJIET SPEĊIFIĊI LI GĦANDHOM JIĠU SODISFATTI MIS- SID L - AWTORIZZAZZJONI TAL- KUMMERĊ
8/ 31 ANNEX III
8/ 31 ANNESS III
10/ 31 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
VIRBAGEN OMEGA 5 MU for dogs and cats
VIRBAGEN OMEGA 5MU għal klieb u qtates
Active substance
Sustanza attiva
Box containing 5 vials of powder fraction and 5 vials with 1 ml of solvent.
Kaxxa b' 5 kunjetti ta 'porzjon tat- trab u 5 kunjetti b' 1ml ta' solvent.
TARGET SPECIES
SPEĊI LI FUQHOM SER JINTUŻA L- PRODOTT
INDICATION(S)
INDIKAZZJONIJIET
The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain a solution containing 5 MU of recombinant interferon.
Il- porzjon freeze- dried irid ikun rikostitwit b' 1ml tad- dilwent speċifiku biex tinkiseb suspensjoni li fiha 5MU ta 'interferon rikombinanti.
Dog:
Klieb:
Cat: as vaccination is contra-indicated in symptomatic phase of FeLV/ FIV infections, effect of VIRBAGEN OMEGA on cat vaccination has not been evaluated.
Qtates: minħabba li t- tilqim hu kontra- indikat fil- fażi sintomatika ta 'infezzjonijiet FeLV/ FIV, l- effett ta' VIRBAGEN OMEGA fuq il- tilqim tal- qtates ma kienx evalwat.
EXP {month/ year} The product should be used immediately after reconstitution.
JIS {xahar/ sena} Il- prodott għandu jintuża minnufih wara r- rikostituzzjoni.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
IL- KLIEM "GĦAT- TRATTAMENT TA ’ L- ANNIMALI BISS ” U KUNDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UŻU, jekk applikabbli
The import, sale, supply and/ or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory, see package leaflet for further information.
Ara l- fuljett fil- pakkett għal aktar tagħrif.
Batch number
Numru tal- lott
13/ 31 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
13/ 31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
VIRBAGEN OMEGA 10 MU for dogs and cats
VIRBAGEN OMEGA 10MU għal klieb u qtates
The freeze-dried fraction must be reconstituted with 1 ml of the specific diluent to obtain a solution containing 10 MU of recombinant interferon.
Il- porzjon freeze- dried irid ikun rikostitwit b' 1ml tad- dilwent speċifiku biex tinkiseb suspensjoni li fiha 10MU ta 'interferon rikombinanti.
Vaccination during and after VIRBAGEN OMEGA treatment is contra-indicated, until the dog appears to have recovered.
It- tilqim matul u wara l- kura b' VIRBAGEN OMEGA hu kontra- indikat, sakemm il- kelb jidher li jkun qed jirkupra.
16/ 31 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
16/ 31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Box containing 2 vials of powder fraction and 2 vials with 1 ml of solvent.
Kaxxa b' 2 kunjetti ta 'porzjon tat- trab u 2 kunjetti b' 1ml ta' solvent.
19/ 31 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
19/ 31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Box containing 1 vial of powder fraction and 1 vial with 1 ml of solvent.
Kaxxa b' kunjett 1 ta 'porzjon tat- trab u kunjett 1 b' 1ml ta' solvent.
22/ 31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
22/ 31 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
KONTENUT SKOND IL- PIŻ, VOLUM JEW NUMRU TA 'DOŻI
5 MU
5MU
ROUTE(S) OF ADMINISTRATION
MOD( I) TA 'AMMINISTRAZZJONI
Intravenous route Cats:
Jingħata ġol- vina Qtates:
Subcutaneous route
Jingħata taħt il- ġilda
EXP: month/ year
JIS: xahar/ sena
23/ 31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23/ 31 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
10 MU
10MU
24/ 31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
24/ 31 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
VIRBAGEN OMEGA Solvent for suspension for injection
VIRBAGEN OMEGA Solvent għas- suspensjoni għall- injezzjoni
26/ 31 PACKAGE LEAFLET
26/ 31 FULJETT TA ’ TAGĦRIF
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ, U L - ISEM U L- INDIRIZZ TAS- SID TA 'L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT, JEKK HUWA DIFFERENTI
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħrajn li mhumiex imsemmija f' dan il- fuljett, jekk jogħġbok informa lill- kirurgu veterinarju tiegħek.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
DOŻA GHAL KULL SPEĊI, METODU U MOD( I) TA 'AMMINISTRAZZJONI
The product should be used immediately after reconstitution.
Il- prodott għandu jintuża minnufih wara r- rikostituzzjoni.
In case of repeated treatments of chronic diseases associated with hepatic, cardiac and renal failure, the corresponding disease has to be monitored prior to administration of VIRBAGEN OMEGA The use of supplementary supportive treatments improves prognosis.
L- użu ta 'kuri ta' sapport supplimentari jtejbu il- pronjosi.
SPECIAL STORAGE PRECAUTIONS
KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN
Store and transport at 4° C ± 2° C.
Aħżen u ittrasporta f' temperatura ta '4°C ± 2°C.
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 insert with you.
F’ każ li tinjetta lilek innifsek bi żball, ħu parir mediku immedjatament, anke jekk ammont żgħir ħafna jkun injettat, u ħu l- fuljett ta ’ tagħrif miegħek.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
DATA META ĠIE RIVEDUT L- AĦĦAR IL- FULJETT INFORMATTIV
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /emea. europa. eu/.
Tagħrif dettaljat dwar dan il- prodott mediċinali veterinarju hu disponibbli fuq is- sit ta 'l- Internet tal - European Medicines Agency (EMEA) http: // www. emea. eu. int /
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rapprezentant lokali tas- sid ta ’ l- awtorizzazzjoni għall- kummerċ.
Rue de la station 17 B-1300 WAVRE Tel.:
Rue de la station 17 B- 1300 WAVRE Tel::
33 (0) 4 92 08 73 00 Danmark VIRBAC S. A.
Danmark VIRBAC S. A.
Magyarország VIRBAC S. A.
Magyarorszag VIRBAC S. A.
33 (0) 4 92 08 73 00 Malta VIRBAC S. A.
Malta VIRBAC S. A.
49 (4531) 805 555 Eesti VIRBAC S. A.
Eesti VIRBAC S. A.
33 (0) 4 92 08 73 00 Ελλάδα VIRBAC S. A.
Ελλάδα VIRBAC S. A.
33 (0) 4 92 08 73 00 Österreich VIRBAC Österreich GmbH A-1180 Wien Tel:
Österreich VIRBAC Österreich GmbH A- 1180 Wien Tel:
Tél.: + 34 93 470 79 40
Tel:
353 61 314 933
Irlanda C & M Veterinary Distributors Limited IE - Limerick Tel:
Portugal VIRBAC DE PORTUGAL LABORATÓRIOS LDA P-2080-Almeirim Tél.:
Portugall VIRBAC DE PORTUGAL LABORATÓRIOS LDA P- 2080- Almeirim Tel:
(351) 243.570 500 Slovenija VIRBAC S. A.
Slovenija VIRBAC S. A.
39 02 48 53 451 Κύπρος VIRBAC S. A.
Slovenska republika VIRBAC S. A.
33 (0) 4 92 08 73 00 Suomi/ Finland VIRBAC S. A.
30/ 31 Κύπρος VIRBAC S. A.
Pharmaceutical Target species Form
Speċi li fuqhom għandu jintuża l - prodott
Oral solution
Soluzzjoni orali Klieb
Yarvitan 5 mg/ ml oral solution for dogs
Yarvitan 5 mg/ ml soluzzjoni orali għall- klieb
Butylated hydroxyanisole (E 320) 2 mg/ ml
Butylated hydroxyanisole (E 320) 2 mg/ ml
For a full list of excipients, see section 6.1
Għal- lista sħiħa tas- sustanzi mhux attivi ara s- sezzjoni 6. 1
A colourless to slightly yellow solution.
Soluzzjoni bla kulur li tagħti daqsxejn fl- isfar.
As an aid in the management of overweight and obesity in adult dogs.
Bħala għajnuna fil- kontroll ta ’ piż żejjed u obesità fi klieb adulti.
To be used as part of an overall weight management programme which also includes appropriate dietary changes.
Biex jintuża bħala parti minn programm sħiħ għal kontroll tal- piż li jinkludi wkoll bidliet xierqa fid- dieta.
Introducing appropriate lifestyle changes (e. g. increased exercise), in conjunction with this weight management programme, may provide additional benefits.
L- introduzzjoni ta ’ bidliet adattati fil- mod ta ’ ħajja (eż aktar eżerċizzji), flimkien ma ’ dan il- programm ta ’ kontroll tal- piż jista ’ jipprovdi benefiċċji addizzjonali.
Do not use in dogs with impaired liver function.
M’ għandux jingħata ‘ l- klieb li għandhom indeboliment fil- fwied.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
M’ għandux jingħata f’ każ ta ’ ipersensittività għas- sustanza attiva jew sustanzi oħra.
Do not use in dogs during pregnancy and lactation.
M’ għandux jingħata ‘ l - klieb waqt it- tqala jew treddigħ.
Do not use in dogs less than 18 months of age.
M’ għandux jingħata ‘ l- klieb li għandhom inqas minn 18- il xahar.
Do not use in dogs in which overweight or obesity is caused by a concomitant systemic disease such as hypothyroidism or hyperadrenocorticism.
M’ għandux jingħata ‘ l- klieb fejn il- piż żejjed jew l- obesità huma kkawżati minn marda sistemika konkomittanti bħal ipotajrojdiżmu jew iperadrenokortiċiżmu.
2/ 20 4.5 Special precautions for use
4. 5 Prekawzjonijiet Speċjali għall- Użu
The use in dogs for breeding purposes has not been evaluated.
Fi klieb għal skopijiet ta ’ tnissil, l- użu tal- prodott ma ġiex evalwat.
If vomiting, significantly reduced appetite or diarrhoea repeatedly occurs, treatment should be interrupted and the advice of a veterinarian should be sought.
2/ 20 F’ każ li jkun hemm remettar, tnaqqis ta ’ l- aptit b’ mod sinifikattiv jew ikun hemm id- dijarrea li tibqa ’ sseħħ b’ mod ripetut, it- trattament għandu jiġi mwaqqaf u għandu jittieħed il- parir tal- veterinarju.
Where treatment is interrupted due to vomiting, it is recommended that when treatment is resumed, the product should be administered after a meal.
F’ każ li t- trattament hu mwaqqaf minħabba remettar, huwa rakkomandat li meta t- trattament jissokta, il- prodott għandu jiġi mogħti wara l- ikel.
In addition, treatment should be interrupted and the advice of a veterinarian should be sought where the observed body weight loss is severe and rapid.
Barra minn hekk it- trattament għandu jitwaqqaf u għandu jittieħed il- parir ta ’ veterinarju meta t- telf fil- piż korporali osservat huwa mgħaġġel u sever..
In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician.
F' każ aċċidentali ta 'amministrazzjoni lilek innifsek, fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta' informazzjoni li jkun fih ġewwa.
If accidental eye contact occurs, flush immediately with copious amounts of water.
F’ każ aċċidentali li jkun hemm kuntatt ma ’ l- għajnejn, laħlaħ minnufih b’ ammonti kbar ta ’ ilma.
A decreased appetite may occur during treatment.
Nuqqas t’ aptit jista ’ jseħħ waqt it- trattament.
This is related to the mode of action of the product and should not be considered as an adverse reaction unless it becomes very significant.
Dan hu relatat mal- mod kif jaħdem il- prodott u m’ għandux jiġi kkonsidrat bħala effett mhux mixtieq sakemm dan ma ssirx sinifikanti ħafna.
Vomiting, diarrhoea or softened stools may occur during treatment.
Jista ’ ikun hemm remettar, dijarea u ppurgar artab waqt it- trattament.
In most cases, these effects are mild and transient.
Fil- maġġoranza tal- każijiet, dawn l- effetti huma ħfief u jgħaddu malajr.
In case an adverse reaction repeatedly occurs or in case the dog stops eating for two consecutive days, treatment should be interrupted and the advice of a veterinarian should be sought.
F’ każ li l- effett mhux mixtieq iseħħ aktar minn darba jew f’ każ li l- kelb jieqaf jiekol għal jumejn wara xulxin, it- trattament għandu jiġi mwaqqaf u għandu jittieħed il- parir tal- veterinarju.
In laboratory studies, decreases in serum albumin, globulin, total protein, calcium and alkaline phosphatase and increases in ALT and AST were detected following administration of the product at the recommended treatment dose.
Fi studji fil- laboratorju, tnaqqis fl- albumina, globulina, proteini totali, kalċju u alkaline phosphatase fis- sirum u żjidiet fl- ALT u AST kienu rilevati wara amministrazzjoni tal- prodott fid- dożi rakkomandati.
In addition, hyperkalaemia was occasionally observed.
Barra minn hekk iperkalemija kienet osservata kull tant żmien.
Generally, the severity of these effects increased with increasing dose.
Ġeneralment, is- severità ta ’ dawn l- effetti żdiedet ma ’ żieda fid- doża.
Typically, these findings normalised, or appeared to be reversing, within two weeks following the end of treatment.
Tipikament, dawn l- effetti ġew lura għan- normal, jew bdew jidhru li qed ibattu, fi żmien ġimagħtejn wara it- twaqqif tat- trattament.
The following adverse reactions were observed during the clinical trials (pooled data*):
L- effetti mhux mixtieqa li ġejjin ġew osservati waqt il- provi kliniċi (tagħrif miġbur minn bosta bnadi *):
Clinical observation
Osservazzjoni klinika
Mitratapide
Mitratapide 20. 0%
Placebo
Plaċebo 5. 6%
vomiting: occasional (≤ 3x)
remettar: okkażjonali (≤ 3x)
vomiting: repeated (> 3 x) diarrhoea / soft stools
remettar: ripetut (> 3 x) dijarrea / ippurgar merħi
10.0% 10.0%
10. 0% 10. 0%
2.2% 4.4%
2. 2% 4. 4%
anorexia / decreased appetite lethargy / weakness
anoreksja / nuqqas t’ aptit telqa / dgħufija
17.8% 5.2%
17. 8% 5. 2%
10.0% 2.2%
10. 0% 2. 2%
* data from 360 dogs over the whole treatment period.
* tagħrif miġbur minn 360 kelb fuq il- perijodu ta ’ trattament kollu.
Do not use in dogs during pregnancy and lactation.
M’ għandux jintuża fi klieb waqt it- tqala u t- treddigħ.
4.8 Interaction with other medicinal products and other forms of interaction
Effetti fuq prodotti mediċinali oħra jew effetti oħra
No drug interactions were observed in studies where Yarvitan was administered concomitantly with NSAIDs (carprofen, meloxicam) or ACE inhibitors (enalapril, benazepril).
Ma kien hemm l- ebda interazzjonijiet osservati fi studji meta Yarvitan ġie mogħti flimkien ma ’ NSAIDs (carprofen, meloxicam) jew inibituri tal- ACE (enalapril, benazepril).
Interactions with other drug types were not specifically investigated.
Interazzjonijiet ma ’ tipi oħra ta ’ mediċini ma ġewx mistħarrġa b’ mod speċifiku.
The absorption of lipid soluble drugs used concomitantly with mitratapide has not been investigated.
L- assorbiment ta ’ mediċini li jinħallu fil- lipidi użati flimkien ma ’ mitratapide ma ġiex mistħarreġ.
Therefore, for dogs receiving treatments in addition to the product, drug interactions should be monitored closely.
Sabiex tagħti d - doża li suppost, il- kelb għandu jintiżen fl- ewwel jum u fil- 35 jum (i. e. fil- bidu ta ’ kull perijodu ta ’
3/ 20 4.9 Amounts to be administered and administration route
3/ 20 trattament).
Treatment should be given with food.
It- trattament għandu jiġi mogħti ma ’ l- ikel.
Use the dosing pipette as provided with the product.
Uża l- pipetta bid- dożaġġ fuqha li hija pprovduta mal- prodott.
During the first 21 days of treatment, the quantity of food the animal receives may remain unchanged.
Matul l- ewwel 21 jum tat- trattament, il- kwantità ta ’ ikel li l- annimal jirċievi tista ’ tibqa l- istess.
Thereafter, feeding should be in accordance with energy requirements for maintenance (to be calculated by the veterinarian).
Imbagħad, l- ikel għandu jingħata skond il- ħtiġijiet energetiċi għall- manteniment (li jrid jiġi kkalkulat mill- veterinarju).
This can be achieved either with a regular pet food or with a low calorie (diet) pet food.
Dan jista ’ jinkiseb jew b’ ikel reġolari ta ’ l- annimali domestiċi jew b’ ikel ta ’ l - annimali domestiċi li fih livell baxx ta ’ kaloriji.
In clinical trials, treated animals rapidly regained weight following cessation of treatment when diet was not restricted.
Fi provi kliniċi, l- annimali trattati malajr żdiedu fil- piż wara l- waqfien tat- trattament meta d- dieta ma kinetx ristretta.
In order to avoid this rebound weight gain, it is necessary to continue the feeding for maintenance regimen after the end of treatment with the product.
Sabiex wieħed jevita din iż- żieda fil- piż mill- ġdid, huwa meħtieġ li jissokta ir- reġim ta ’ l- ikel għall- manteniment wara t- tmiem tat- trattament bil- prodott.
Mitratapide therapy should be restricted to one treatment course for an individual dog.
It- trattament b’ mirtrapide għandu jiġi ristrett għal kors ta ’ trattament wieħed għal kull kelb.
The following clinical signs were observed after 3 or 5 times overdosing in dogs: softened or liquid faeces, vomiting, salivation, anorexia, severe weight loss, emaciated appearance, dehydration and pale mucosae.
Is- sinjali kliniċi li ġejjin ġew osservati wara doża eċċessiva ta ’ minn 3 sa 5 darbiet fil- klieb: ippurgar maħlul jew likwidu, remettar, tbezżlieq, anoreksja, telf ta ’ piż sever, dehra magħluba, diżidrazzjoni u mukosa bajdanija.
In case of accidental overdosing, symptomatic therapy should be administered.
F’ każ aċċidentali li tingħata doa eċċessiva, għandha tingħata terapija għas- sintomi.
No specific antidote is available.
Ma jeżisti l- ebda antidotu speċifiku.
Peripherally acting antiobesity products, ATCvet Code:
Prodotti b’ azzjoni periferika kontra l- obesità, Kodiċi vet ATC:
Mitratapide is a potent inhibitor of the microsomal triglyceride transfer protein (MTP).
Mitratapide huwa impeditur potenti tal- proteina tat- trasferriment tat- trigliċeridi microsomali (MTP).
Administration of mitratapide to dogs results in reduced uptake of dietary lipids, dose dependent decreases in serum cholesterol and triglyceride and an increased presence of triglyceride containing droplets in enterocytes.
Amministrazzjoni ta ’ mitratapide lill- klieb tirriżulta fi tnaqqis ta ’ l- assimilazzjoni tal- lipidi mill- ikel, tnaqqis ta ’ kolesterol u t- trigliċeridi fis- sirum li jiddependi mid- doża u żieda fil- preżenza tat - trigliċeridi fl- enterocytes.
It is assumed that these effects are mediated by MTP inhibition at the level of the enterocyte.
Huwa preżunt li dawn l- effetti jsiru permezz ta ’ l- impediment tal- MTP fil - livell tal- enterocytes.
This results in blockage of the uptake of dietary lipids.
Dan jirriżulta f’ imblokk fl- assimilazzjoni tal- lipidi mill- ikel.
Mitratapide also has a slight appetite decreasing effect, which is linked to its mode of action.
Mitratapide għandu wkoll kemmxejn effett li jnaqqas l- aptit, li huwa marbut mal- mod ta ’ l- azzjoni tiegħu.
Accumulation of triglycerides inside the enterocytes may be followed by decreased appetite.
Akkumulazzjoni ta ’ trigliċeridi ġewwa l- enterocytes jistgħu jikkawżaw sensazzjoni ta ’ xaba ’, li b’ feedback negattiv twassal għat- tnaqqis fl- aptit.
Mitratapide has no central effect.
Mitratapide m’ għandu l- ebda effett ċentrali.
In clinical trials, the following weight loss percentages were obtained:
Fil- provi kliniċi, il- perċentwali ta ’ telf fil- piż li ġejjin ġew miksuba:
Percentages of dogs per weight loss category for mitratapide versus placebo:
Percentwali ta ’ klieb għal kull kategorija ta ’ telf ta ’ piż għal mitratapide kontra plaċebo:
% of treated dogs*
% ta ’ klieb trattati * kategorija ta ’ telf ta ’ piż
EU field trial
provi fl- UE
US field trial
provi fl- Istati Uniti
pooled data
tagħrif miġbur
mitratapide placebo mitratapide placebo
mitratapide plaċebo mitratapide plaċebo
≥ 10% ≥ 7.5% ≥ 5%
≥ 10% ≥ 7. 5% ≥5%
6.8 11.4 22.7
6. 8 11. 4 22. 7
25.2 9.5 22.5 8.1 41.7 11.9 47.3 11.6 63.8 31.0 65.1 26.7
25. 2 9. 5 22. 5 8. 1 41. 7 11. 9 47. 3 11. 6 63. 8 31. 0 65. 1 26. 7
23.8 44.5 64.4
23. 8 44. 5 64. 4
*: in line with the recommended treatment schedule
*: skond l- iskeda rakkomandata ta ’ trattament
4/ 20 5.2 Pharmacokinetic particulars
4/ 20 5. 2 Tagħrif Farmakokinetiċi
Laboratory animals and dogs rapidly absorb orally administered mitratapide.
Annimali tal- laboratorju u klieb malajr jassorbu mitratapide mogħti oralment.
The most important metabolic transformation is sulphoxidation, which produces three active metabolites.
L- aktar tibdil metaboliku importanti huwa s- sulfossidazzjoni, li tipproduċi tliet metaboliti attivi.
Following oral administration, the bioavailability of mitratapide (parent compound and metabolites) is in the range from 55 to 69%, the volume of distribution is approximately 5 l/ kg.
Wara teħid orali, il - bijodisponibilità ta ’ mitratapide (bhala mitratapide u l- metaboliti tiegħu) hija bejn 55 sa 69%, il- volum ta ’ firxa huwa bejn wieħed u ieħor 5 l/ kg.
Mitratapide and its metabolites bind very extensively (> 99%) to plasma proteins and distribute to the tissues.
Mitratapide u l- metaboliti tiegħu jitwahhdu estensivament ħafna (> 99%) mal- proteini tal- plażma u jinfirxu fit- tessuti.
After multiple dosing, the highest concentrations are present in the adrenal glands, liver, jejunum and kidney, but there is no exposure in the brain, excluding any central effect of the product.
Wara ħafna dożaġġi, l- ogħla konċentrazzjonijiet ikunu preżenti fil- glandoli adrenali, il- fwied, il- jeġunum u l- kilwa, imma m’ hemm ma jinfirix fil- moħħ, li jeskludi kwalunkwe effett ċentrali tal- prodott.
Excretion is rapid and mainly via the faeces.
L- eliminazzjoni hija mgħaggla u fil- parti l- kbira ssir permezz ta ’ l- ippurgar.
In fed dogs, a single dose of 0.63 mg mitratapide/ kg bodyweight results in maximum concentrations of the parent substance in plasma of on average 0.012 µg/ ml attained 3.5 hours after dosing; the sulphoxide metabolites reach maximum concentration of on average 0.0136 µg/ ml and 0.0168 µg/ ml, respectively after 6.5 hours and 8.5 hours; the sulphone metabolite reaches 0.0092 µg/ ml after 17.5 hours.
Fi klieb mitmugħin, doża waħda ta 0. 63mg mitratapide/ kg piż korporali tirriżulta f’ konċentrazzjonijiet massimi tas- sustanza oriġinali fil- plażma ta ’ madwar 0. 012 ng/ ml li jintlaħqu 3. 5 sigħat wara d - dożaġġ; il- metaboliti sulfossidi jilħqu konċentrazzjoni massima medja ta ’ 0. 0136 ng/ ml u 0. 0168 ng/ ml, rispettivament wara 6. 5 sigħat u 8. 5 sigħat; il- metabolita sulphone tilħaq 0. 0092 ng/ ml wara 17– il siegħa u nofs.
At the end of a three week dosing period, mitratapide attains average steady-state concentrations of 0.0068 µg/ ml, the sulphoxide metabolites 0.0089 µg/ ml and 0.0167 µg/ ml, respectively, the sulphone 0.0471 µg/ ml.
Fl- aħħar ta ’ perijodu ta ’ dożaġġ ta ’ tliet ġimgħat, mitratapide jilħaq konċentrazzjonijiet fissi f‘ medja ta ’ 0. 0068 ng/ ml, il- metaboliti sulfossidi 0. 0089 ng/ ml u 0. 0167 ng/ ml, rispettivament, is- sulphone 0. 0471 ng/ ml.
The terminal plasma half-life is 6.3 hours for mitratapide, 9.8 hours and 11.7 hours for the sulphoxides, respectively, and 44.7 hours for the sulphone metabolite.
Il- ħalf- life finali tal- plażma hija 6. 3 sigħat għal mitratapide, 9. 8 sigħat u 11. 7 sigħat għas- sulfossidi, rispettivament, u 44. 7 sigħat għall- metabolit sulphone.
The pharmacokinetic parameters display variable dependency on dose and vary slightly between the first and the second three week treatment periods of a complete treatment schedule.
Il- parametri farmakokinetiċi juru dipendenza varjabbli fuq id- doża u jvarjaw xi ftit bejn l - ewwel u t- tieni perijodu ta ’ trattament ta ’ tliet ġimgħat ta ’ skeda kompleta ta ’ trattament.
3 years Shelf-life after first opening the immediate packaging:
Sentejn Żmien li l- prodott jibqa ’ tajjeb wara li jinfetaħ l- ippakkjar:
Do not refrigerate. This veterinary medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali veterinarju m’ għandux bżonn ta ’ l- ebda kondizzjoni speċjali sabiex jinħażen.
After each dose, the pipette should be washed and dried and the bottle cap screwed back on tightly.
Wara kull doża, il- pipetta għandha tiġi mlaħalħa u mnixxfa u l- għatu tal- flixkun magħluq sew.
55, 120 or 210 ml amber glass bottle (type III) with a child resistant polypropylene closure and dosing pipette.
Fliexken tal- ħġieġ ambra ta ’ 55, 120 jew 210 ml (tip III) b’ tap tal- polypropylene reżistenti għat- tfal u pipetta tad- dożaġġ.
The dosing pipette has a gradation in body weight: • up to 36 kg for the 55 ml bottle • up to 36 kg for the 120 ml bottle • up to 48 kg for the 210 ml bottle
Il- pipetta tad- dożaġġ hija gradata skond il- piż korporali: • sa 10 kg għal flixkun ta ’ 55 ml • sa 36 kg għal flixkun ta ’ 120 ml • sa 48 kg għal flixkun ta ’ 210 ml
5/ 20 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
5/ 20 6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użata jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Mediċina veterinarja li ma ġietx użata jew prodotti oħra għar- rimi li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż
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 tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu
6/ 20 ANNEX II
6/ 20 ANNESS II
Name and address of the manufacturer(s) responsible for batch release
Isem u indirizz tal- manufattur( i) tas- sustanza( i) bioloġika( ċi) attiva( i)
To be supplied only on veterinary prescription.
Sabiex jiġu mogħtija biss bi preskrizzjoni veterinarja
8/ 20 ANNEX III
8/ 20 ANNESS III
10/ 20 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 20 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Yarvitan 5 mg/ ml oral solution for dogs
Yarvitan 5 mg/ ml soluzzjoni orali għal klieb
55 ml: ≤ 10 kg BW 120 ml: ≤ 22 kg BW 210 ml: ≤ 40 kg BW
55 ml: ≤ 10 kg piż korporali 120 ml: ≤ 22 kg piż korporali 210 ml: ≤ 40 kg piż korporali
Once opened, use within 3 months.
La darba jinfetaħ, uża fi żmien 3 xhur.
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 għar- rimi li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż
For animal treatment only – to be supplied only on veterinary prescription.
Għal Trattament ta ’ l- Annimali Biss għandu jingħata biss bi preskrizzjoni medika.
B-2340 Beerse, Belgium
B- 2340 Beerse, Il- Belġju
12/ 20 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
12/ 20 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
LABEL AMBER GLASS BOTTLE 55 ML
TIKKETTA TAL- FLIXKUN AMBRA TAL- ĦĠIEĠ TA ’ 55 ML
Oral use.
Soluzzjoni orali.
EXP {month/ year} Once opened, use within 3 months.
JIS {xahar/ sena} La darba jinfetaħ, uża fi żmien 3 xhur.
13/ 20 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
13/ 20 DETTALJI LI GĦANDHOM JIDHRU FUQ L- IPPAKKJAR EWLIENI
LABEL AMBER GLASS BOTTLE 120 and 210 ml
TIKKETTA TAL- FLIXKUN AMBRA TAL- ĦĠIEĠ 120 u 210 ml
Once opened, use within 3 months.
La darba jinfetah, uża fi żmien 3 xhur.
Do not refrigerate
Tagħmlux fil- friġġ
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- PROVISTA U L- UŻU, jekk applikabbli,
16/ 20 PACKAGE LEAFLET Yarvitan 5 mg/ ml oral solution for dogs
16/ 20 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Yarvitan 5 mg/ ml soluzzjoni orali għal klieb
Read all of this leaflet carefully before you start administering the medicine to your dog: • Keep this leaflet.
Aqra dan il- fuljett sew qabel ma tibda tagħti l- mediċina lil kelb tiegħek: • Żomm dan il- fuljett.
You may need to read it again • If you have further questions, please ask your veterinary surgeon or your pharmacist • This medicine has been prescribed for your dog only and you should not pass it on to others.
Jista ’ jkollok bżonn terġa taqrah • Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib veterinarju jew lill- ispiżjar tiegħek • Din il- mediċina ġiet preskritta għall- kelb tiegħek u m’ għandekx tgħaddiha lil kelb ieħor
Yarvitan 5 mg/ ml oral solution for dogs Mitratapide
Yarvitan 5 mg/ ml soluzzjoni orali għal klieb Mitratapide
Mitratapide 5 mg/ ml Butylated hydroxyanisole (E 320) Yarvitan is a colourless to slightly yellow solution.
Mitratapide 5 mg/ ml Butylated hydroxyanisole (E 320) Soluzzjoni bla kulur li tagħti daqsxejn fl- isfar.
Yarvitan is indicated as an aid in the management of overweight and obesity in adult dogs.
Yarvitan huwa indikat bħala għajnuna fil- kontroll ta ’ piż żejjed u obesità fi klieb adulti.
The treatment is part of an overall weight management programme which also includes a nutrition programme.
Biex jintuża bħala parti minn programm sħiħ għal kontroll tal- piż li jinkludi wkoll bidliet xierqa fid- dieta.
Introducing appropriate lifestyle changes (e. g. increased exercise), in conjunction with this weight management programme, may provide additional benefits.
L - introduzzjoni ta ’ bidliet adattati fil- mod ta ’ ħajja (e. g. aktar eżerċizzji), flimkien ma ’ dan il- programm ta ’ kontroll tal- piż jista ’ jipprovdi benefiċċji addizzjonali.
Do not administer Yarvitan: • if your dog has impaired liver function. • if your dog is hypersensitive (allergic) to mitratapide or to any of the other ingredients. • if your dog is pregnant or during lactation. • in dogs less than 18 months of age. • if overweight or obesity in your dog is caused by a concomitant systemic disease such as hypothyroidism (this is due to a malfunction of the thyroid gland) or hyperadrenocorticism. (this is due to a malfunction of the adrenal gland).
M’ għandekx tagħti Yarvitan: • jekk il- kelb tiegħek għandu l- fwied indebolit. • jekk il- kelb tiegħek għandu ipersensittività (allerġiku) għall- mitratapide jew xi wieħed mis - sustanzi l- oħra. • jekk il- kelba tiegħek hija tqila jew qed tredda ’. • ‘ il- klieb li għandhom inqas minn 18- il xahar. • jekk il- piż żejjed jew l- obesità fil- kelb tiegħek huma kkawżati minn marda sistemika konkomittanti bħal ipotajrojdiżmu (kawża ta ’ malfunzjoni tal- glandola tat- tajrojd) jew iperadrenokortiċiżmu. (kawża ta ’ malfunzjoni tal- glandola adrenali).
Tell your veterinary surgeon if you notice any of the following: • significant loss of appetite.
Għarraf lit- tabib veterinarju hekk tinnota xi wieħed minn dawn li ġejjin: • nuqqas t’ aptit sinifikanti.
Loss of appetite may occur during treatment.
In- nuqqas t’ aptit jista ’ jseħħ waqt it- trattament.
This is related to the mode of action of the product and should not be considered as a side effect, unless it becomes very significant (this is when your dog stops eating for two consecutive days). • vomiting • diarrhoea • softened stools
Dan hu relatat mal - mod kif jaħdem il- prodott u m’ għandux jiġi kkonsidrat bħala effett mhux mixtieq, għajr meta jsir sinifikanti ħafna (dan meta l- kelb ikun waqaf milli jiekol għal jumejn konsekuttivi). • remettar • dijarrea • ippurgar merħi
In most of the cases, these side effects are mild and do not last very long.
Fil- biċċa l- kbira tal- każijiet, dawn l- effetti kollaterali huma ħfief u ma jdumux ħafna.
In case a side effect repeatedly occurs or in case the dog stops eating for two consecutive days, stop the administration of Yarvitan to your dog and seek the advice of your veterinary surgeon as soon as possible.
F’ każ illi effett kollaterali jseħħ b’ mod ripetut jew inkella jekk il- kelb jieqaf jiekol għal jumejn sħaħ, waqqaf l - amministrazzjoni tal- Yarvitan lill- kelb tiegħek u fittex li tieħu l- parir tal- veterinarju tiegħek kemm jista ’ jkun malajr.
In laboratory studies, decreases in serum albumin, globulin, total protein, calcium and alkaline phosphatase and increases in ALT and AST were detected following administration of the product at the recommended treatment dose.
Fi studji tal- laboratorju, kien hemm tnaqqis rilevat fl- albumina, globulina, proteini totali, kalċju u alkaline phosphatase fis- sirum u żjieda fl- ALT u AST wara l- għoti tal- prodott fid- doża ta ’ trattament irrakomandata.
In addition, hyperkalaemia was occasionally observed.
Barra minn hekk, minn daqqiet ġiet osservata l- iperkalemija.
Generally, the severity of these effects increased with increasing dose.
Ġeneralment, is- severita ta ’ dawn l- effetti żdidiet b’ żieda fid- doża.
Typically, these findings normalised, or appeared to be reversing, within two weeks following the end of treatment.
Tipikament, dawn l- effetti marru lura għan- normal, jew bdew jidhru li qed ibattu fi żmien ġimagħatejn wara l- aħħar tat- trattament.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħra mhux msemmija f’ dan il- fuljett, jekk jogħġbok informa lit - tabib veterinarju tiegħek:
Always administer Yarvitan exactly as your veterinary surgeon has instructed you.
Dejjem għandek tagħti Yarvitan kif jgħidlek il- veterinarju tiegħek.
You should check with your veterinary surgeon if you are unsure.
Għandek tiċċekkja mal- veterinarju tiegħek jekk inti m’ intiex ċert.
The usual dose is once daily 0.63 mg mitratapide/ kg bodyweight (1 ml of the product per 8 kg).
Id- doża li ġeneralment tingħata hi ta ’ 0. 63 mg mitratapide/ kg piż korporali kuljum (1 ml tal- prodott għal kull 8 kg).
The dosing pipettes provided with the product show graduations corresponding to the correct body weight of the dog.
Il- pipetti tad- dożaġġ ipprovduti mal- prodott juru l - gradi li jikkorispondu mal- piż korporali attwali tal- kelb.
Administer the product orally during 2 periods of 21 days with an interval of 14 days without treatment in between.
Agħti l- prodott oralment f’ 2 perijodi ta ’ 21 jum b’ intervall ta ’ 14- il jum mingħajr ma jsir ebda trattament bejnithom.
Day 1-21
Jum 1- 21
Day 22-35
Jum 22- 35
Day 36-56
Jum 36- 56
treatment
trattament
no treatment
l- ebda trattament
normal feeding
Ikel normali
nutrition programme
Programm ta ’ nutrizzjoni
In order to allow proper dosing, the dog should be weighed on day 1 and day 35 (this is at the start of each treatment period).
Sabiex tingħata d- doża li suppost, il- kelb għandu jintiżen fl- 1 jum u fil- 35 jum (dan hu l- bidu ta ’ kull perijodu ta ’ trattament).
Use the dosing pipette as provided with the product.
Uża l- pipetta li tiddoża kif ipprovduta mal- prodott.
Fill the syringe by pulling the plunger until it reaches the mark on the dosing pipette corresponding to the correct body weight of the dog.
Imla s- siringa billi tiġbed il- planġer sakemm jilħaq il- marka tal- pipetta li tikkorrispondi għal piż korporali korrett tal- kelb.
Treatment should be given with food.
It- trattament għandu jingħata ma ’ l- ikel.
Therefore, administer the product with the syringe onto a portion of the food.
Għalhekk amministra l- prodott bis- siringa f’ porzjon ta ’ l- ikel.
Once the dog has eaten the complete portion, give the remaining amount of food to the dog.
Ġaladarba l- kelb ikun kiel il- porzjon kollu, agħti l- ammont li jmiss ta ’ ikel lill- kelb.
After each dose, the syringe should be removed from the bottle.
Wara kull doża, is- siringa għandha titneħħa minn ġol- flixkun.
The pipette should be washed and dried and the cap should be screwed back on tightly.
Il- pipetta għandha tiġi mlaħalħa u mnixxfa u l- għatu magħluq sew.
18/ 20 During the first 21 days of treatment, the quantity of food the animal receives may remain unchanged.
18/ 20 Matul l- ewwel 21 jum ta ’ trattament, il- kwantità ta ’ ikel li jirċievi l- annimal tista ’ jibqa ’ l- istess.
Thereafter, your dog should follow a nutrition programme.
Wara, il- kelb tiegħek għandu jsegwi programm ta ’ nutrizzjoni.
Your veterinary surgeon will advise you on the type of food your dog will need.
It- tabib veterinarju tiegħek għandu jagħtik parir fuq it- tip ta ’ ikel li l- kelb tiegħek jeħtieġ.
This can be achieved either with a regular pet food or with a low calorie (diet) pet food.
Dan jista ’ jinkiseb jew b’ ikel regolari ta ’ l- annimali domestiċi jew b’ ikel ta ’ l- annimali domestiċi li għandu ftit kaloriji (dieta).
In order to avoid rebound weight gain, it is necessary to continue the feeding for maintenance regimen after the end of treatment with the product.
Sabiex jiġi evitat li jerġa jiżdied il- piż, huwa meħtieġ li jissokta r- reġim ta ’ l- ikel għall- manteniment wara t- tmiem tat- trattament bil- prodott.
Do not use after the expiry date stated on the label and carton (EXP.).
Tużax wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna (JIS.).
Special precautions for use in animals The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Prekawzjonijiet speċjali għall- użu fl- annimali Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabilita waqt it- tqala u fi żmien il- ħalib.
Please inform your veterinary surgeon if your dog is taking or has recently taken any other medicines, even those not prescribed.
Jekk jogħġbok għarraf lit- tabib veterinarju jekk il- kelb tiegħek qed jieħu jew riċentement ħa mediċini oħra, anke dawk mhux preskritti.
The absorption of lipid soluble drugs used concomitantly with mitratapide has not been investigated.
Interazzjonijiet ma ’ tipi oħra ta ’ mediċini ma ġewx mistħarrġa b’ mod speċifiku.
Your veterinary surgeon should monitor closely the intake of any other medicines in addition to the product.
L - assorbiment ta ’ mediċini li jinħallu fil- lipidi użati flimkien ma ’ mitratapide ma ġiex mistħarreġ.
In case vomiting, diarrhoea, softening stools repeatedly occurs or in case the dog stops eating for two consecutive days, stop the administration of Yarvitan to your dog and seek the advice of your veterinary surgeon as soon as possible.
F’ każ li jkun hemm remettar, dijareja jew l- ippurgar ikun artab ripetutament jew jekk il- kelb ma jiekolx għal jumejn wara xulxin, waqqaf l- amministrazzjoni tal- Yarvitan lill- kelb tiegħek u ħu l- parir tal- veterinarju tiegħek kemm jista ’ jkun malajr.
Where treatment is interrupted due to vomiting, it is recommended that when treatment is resumed, the product should be administered after a meal.
F’ każ li t- trattament hu interrot minħabba r- remettar, huwa rakkomandat li meta t- trattament jissokta, il- prodott għandu jiġi mogħti wara ikla.
In addition, treatment should be interrupted and the advice of a veterinarian should be sought where the observed body weight loss is severe and rapid.
Barra minn hekk it- trattament għandu jitwaqqaf u għandu jittieħed il- parir ta ’ veterinarju meta t- telf fil- piż korporali osservat huwa mgħaġġel u sever.
In case of accidental overdosing, symptomatic therapy should be administered.
F’ każ li tingħata doża eċċessiva aċċidentali, għandha tingħata terapija għas- sintomi.
Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician.
Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali F' każ aċċidentali ta ’ amministrazzjoni lilek innifsek, fittex tabib mal- ewwel u qis li turih il- pakkett jew il- fuljett ta 'informazzjoni li jkun fih ġewwa.
Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jiġu mormija ġo l- ilma jew ma ’ l- iskart domestiku.
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 tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall - Mediċini (EMEA) http: // emea. europa. eu
Pack sizes – amber glass bottles containing:
Daqsijiet tal- pakkett – flieken tal- ħġieġ ambra: li fihom:
55ml: ≤ 10 kg bodyweight, 120ml: ≤ 22 kg bodyweight, 210ml: ≤ 40 kg bodyweight.
55ml: ≤ 10 kg piż korporali, 120ml: ≤ 22 kg piż korporali, 210ml: ≤ 40 kg piż korporali.
What is Zactran?
X' inhu Zactran?
Zactran is a solution for injection for cattle that contains the active substance gamithromycin (150 mg/ ml).
Zactran huwa soluzzjoni għall- injezzjoni għall- bovini li fiha s- sustanza attiva gamithromycin (150 mg/ ml).
What is Zactran used for?
Għal xiex jintuża Zactran?
Zactran is an anibiotic.
Zactran huwa antibijotiku.
It is used in cattle to treat or to prevent Bovine Respiratory Disease (BRD) caused by the bacteria Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Jintuża fil- bovini biex jittratta jew jipprevjeni l- Marda Respiratorja fil- Bovini (BRD) ikkawżata mill- batterji Mannheimia haemolytica, Pasteurella multocida u Histophilus somni.
When using Zactran to prevent BRD the presence of the disease in the herd should be established first.
Meta jintuża Zactran għall- kura preventiva għal BRD għandu jiġi stabbilit li hemm il- marda fil- merħla qabel it- trattament.
Zactran is given as a single subcutaneous (under the skin) injection.
Zactran jingħata bħala injezzjoni waħda taħt il- ġilda.
The dose to use is calculated based on the weight of the animal being treated.
Id- doża li għandha tintuża hija kkalkulata skont il- piż tal- annimal li jkun qed jiġi trattat.
Animals weighing more than 250 kg will need to be injected at more than one site.
Għal annimali li jiżnu iktar minn 250 kg, ikun meħtieġ li jkunu injettati f’ iktar minn post wieħed.
How does Zactran work?
Kif jaħdem Zactran?
The active substance of Zactran, gamithromycin, is an antibiotic of the macrolide group.
Is- sustanza attiva f’ Zactran, gamithromycin, hija antibijotiku tal- grupp ta ’ makrolidi.
It works by blocking the bacteria’ s ribosomes, which are the parts of the cells where proteins are produced, and consequently inhibiting the growth of bacteria.
Taħdem billi timblokka r- ribosomi tal- batterji, il- parti taċ- ċelloli li jipproduċu l- proteini, u b’ hekk tinibixxi t- tkabbir tal- batterji.
How has Zactran been studied?
Kif ġie studjat Zactran?
Appropriate studies have been made to show the effectiveness of Zactran in cattle.
Studji xierqa twettqu biex juru l- effikaċja ta ’ Zactran fil- bovini.
The main clinical studies were carried out on farms in a number of countries in Europe, as well as outside the EU.
L- istudji kliniċi ewlenin twettqu f’ azjendi agrikoli f’ għadd ta ’ pajjiżi madwar l- Ewropa, kif ukoll barra l- UE.
For the treatment of BRD, the effect of Zactran was studied in comparison to another macrolide antibiotic (tulathromycin) already authorised in the EU, in cattle already affected by the disease.
Għat- trattament ta ’ BRD, ġie studjat l- effett ta ’ Zactran meta mqabbel ma ’ antibijotiku makrolidu ieħor (tulathromycin) li kien diġà awtorizzat fl- UE, fil- bovini li diġà kienu jbatu mill- marda.
For the prevention of BRD the effect of Zactran was studied in comparison to placebo (dummy treatment) in cattle which had been in contact with diseased animals on the same farm and, therefore, likely to also develop the disease.
Għall- prevenzjoni ta ’ BRD, l- effett ta ’ Zactran ġie studjat fi tqabbil ma ’ plaċebo (trattament finta) fil- bovini li kellhom kuntatt ma ’ annimali morda fl- istess farm u li, għalhekk, kien hemm il- probabbiltà li tiżviluppa fihom il- marda.
What benefit has Zactran shown during the studies?
Liema benefiċċju wera Zactran waqt l- istudji mwettqa?
Zactran has been shown to be efficacious in the treatment and prevention of BRD, associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Zactran wera li huwa effikaċi fit- trattament u l- prevenzjoni ta ’ BRD, assoċjata mal - Mannheimia haemolytica, Pasteurella multocida u Histophilus somni.
In the treatment of BRD Zactran has been shown to be as effective as tulathromycin.
Fit- trattament ta ’ BRD Zactran wera li huwa effikaċi daqs tulathromycin.
What is the risk associated with Zactran?
X’ inhu r- riskju assoċjat ma ’ Zactran?
After injection of Zactran, up to 45% of animals will show some swelling at the site of injection.
Nefħiet fil- post tal- injezzjoni jistgħu jiżviluppaw f’ sa 45% tal- annimali injettati b’ Zactran.
The animals may also show some signs of slight pain for one day.
L - annimali jistgħu jħossu wkoll xi ftit uġigħ għal jum wieħed.
The swelling generally resolves in 3 to 14 days but may persist in some animals for up to 35 days after treatment.
In- nefħiet ġeneralment jinżlu fi żmien minn 3 ġranet sa 14 il- ġurnata iżda f’ xi annimali jistgħu jippersistu sa 35 ġurnata wara t- trattament.
People with known hypersensitivity (allergy) to similar antibiotics (macrolide class) should avoid contact with Zactran.
Nies li huma ipersensittivi (allerġiċi) għal antibiotici simili (il- klassi tal- makrolidi) għandhom jevitaw li jkollhom kuntatt ma ’ Zactran.
Zactran may cause irritation to the eyes or the skin.
Zactran jista ’ jikkawża irritazzjoni fl- għajnejn jew fil - ġilda.
Therefore, contact with skin or eyes should be avoided.
Għalhekk għandu jiġi evitat kwalunkwe kuntatt mal- ġilda u l- għajnejn.