qanastek/EMEA-V3 huggingface dataset:
Imidacloprid, 1-(6-Chloro-3-pyridylmethyl)-N-nitro-imidazolidin-2-ylideneamine is an ectoparasiticide belonging to the chloronicotinyl group of compounds.
Imidakloprid, 1 - (6- Chloro- 3- pyridylmethyl) - N- nitro- imidazolidin- 2- ylideneamin hija sustanza, kontra l- parassiti li jgħixu fuq il- pil jew ġilda, li tagħmel mal- grupp ta´sustanzi msejħa chloronicotinyl.
Chemically, it is more accurately described as a chloronicotinyl nitroguanidine.
Mil - lat tal- kimika tissejjaħ chloronicotinyl nitroguanidine.
Imidacloprid is effective against larval flea stages and adult fleas.
Imidakloprid huwa effettiv kontra l- istadju tal - larva tal- bergħud u briegħed adulti.
Flea larvae in the pet’ s surroundings are killed after contact with a pet treated with the product.
Briegħed fi stat ta´ larva li jkunu fl- inħawi fejn ikun qiegħed l - annimal, jiġu meqruda wara li jiġu f´kuntatt ma’ l- annimal li jkun itrattat bil- prodott.
The ensuing inhibition of cholinergic transmission in insects results in paralysis and death.
Imidakloprid għandu affinita´ qawwija fuq it- tessut/ organu li jirrispondi għall- Aċetilkolina Nikotinerġika fir- reġjun post sinaptiku tas- sistema nervuża ċentrali tal- bergħud. In- nuqqas ta´ trasmissjoni kolinerġika li jiġi kkaġunat fuq l- insett, jipparalizza u joqtol l- insett.
Due to the weak nature of the interaction with mammalian nicotinergic receptors and the postulated poor penetration through the blood-brain barrier in mammals, it has virtually no effect on the mammalian CNS.
Minħabba li l- effett ta´ l - Imidakloprid fuq it - tessuti/ organi, li jirrispondu għal sustanzi nikotinerġiċi fuq l- annimali li jreddgħu huwa żgħir ħafna, u l- penetrazzjoni meħtieġa fil- blood- brain barrier ta´ l- annimali li jreddgħu hija żgħira ħafna, dan m´għandux effett fuq is- sistema ċentrali ta´ l- annimali li jreddgħu.
Imidacloprid has minimal pharmacological activity in mammals.
Imidakloprid għandu effet farmakoloġiku minimali fuq l- annimali li jreddgħu.
Moxidectin is active against larval stages (L3, L4) of Dirofilaria immitis.
Moksidektin, 23 – (O- metiloksim) - F28249 alpha huwa lattonju makroċikliku tat- tieni ġenerazzjoni mill- familja ta’ mibelmiċin. Din hija parassita li taħdem kontra ħafna parassiti interni u esterni. Moksidektin taħdem kontra stadji tal- larva (L3, L4) tad- Dirofilaria immitis.
It is also active against gastrointestinal nematodes.
Hija taħdem ukoll kontra ħniex gastro- intestinali.
Moxidectin interacts with GABA and glutamate-gated chloride channels.
Moksidektin għandu effett fuq aċidu gammaaminobutiriku u Glutamate- gated chloride channels.
This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state.
Dan jikkaġuna l- ftuħ tal- kanali tal- kloru ta´ l- għaqda post sinaptika, d- dħul ta´jone tal- kloru u l- induzzjoni ta´stat ta´mistrieħ irriversibbli.
The result is flaccid paralysis of affected parasites, followed by their death and/ or expulsion.
Dan jirriżulta paraliżi mitluqa fuq il- parassita affetwata li jwassal għall- mewt u/ jew qerda tagħha.
Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 1 to 2 days after treatment in cats.
5. 2 Tagħrif Farmakokinetiċi
Following absorption from the skin, moxidectin is distributed systemically and is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.
Dan jintwera
Environmental properties
Propjetajiet ambjentali
See section 6.6.
Ara sezzjoni 6. 6
None known.
M' hemm xejn magħruf.
Shelf life of the veterinary medicinal product as packaged for sale:
Żmien ta’ tiżmim tal- prodott mediċinarju huwa muri fuq il- pakkett tal- bejħ:
6.4 Special precautions for storage
Tagħrif speċjali dwar kif għandu jinħażen
Do not store above 30°C.
Taħżinx fejn it- temperatura tkun l´ fuq minn 30 °C.
Pack sizes
Qies tal- pakkett
0.4 ml and 0.8 ml per pipette
0. 4 ml, u 0. 8 ml kull pipetta
Blister pack containing 3, 4, 6, 21 or 42 unit dose pipettes
Strixxi li għandhom pipetta b´doża ta´ 3, 4, 6, 21 jew 42
Container material
Kontenut tal- kontenitur
White polypropylene unit dose pipette with screw cap
Pipetta b´doża waħda tal- polipropilin abjad b´tap bil- kamin
Not all pack sizes may be marketed.
Jista´ jkun li mhux id- daqs tal- pakketti kollha jista´qegħdin fis- suq.
Any unused 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 li ntużaw għal din il- mediċina għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
Advocate should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
Advocate ma għandu qatt jitħalla jmur man- nixxiegħat ta´ l- ilma minħabba li jista´jkun ta´periklu għall - ħut jew ħlejqiet oħra akwatici.
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 /.
Advocate spot-on solution for small dogs Advocate spot-on solution for medium dogs Advocate spot-on solution for large dogs Advocate spot-on solution for extra-large dogs
Advocate - taħlita likwida għal użu lokalizzat fuq klieb ta´ kobor medju Advocate - taħlita likwida għal użu lokalizzat fuq klieb kbar Advocate - taħlita likwida għal użu lokalizzat fuq klieb kbar ħafna
Advocate for dogs contains 100 mg/ ml imidacloprid and 25 mg/ ml moxidectin.
Advocate għall- klieb li fih 100 mg/ ml Imidakloprid u 25 mg/ ml Moksidektin
Each unit dose (pipette) delivers:
Kull doża waħda tagħti:
Unit Dose
Doża waħda
Advocate for large dogs (> 10-25 kg) Advocate for extra-large dogs (> 25-40 kg)
Advocate għall- klieb żgħar (≤ 4 kg) Advocate għall- klieb ta´ kobor medju (> 4- 10 kg) Advocate għall- klieb kbar (> 10- 25 kg) Advocate għall- klieb kbar ħafna (> 25- 40 kg)
Benzyl alcohol Butylhydroxytoluene 1 mg/ ml (E 321; as antioxidant)
Benzyl alcohol 1 mg/ ml butylhydroxytoluene( E321; bħala antiossidant)
For dogs suffering from, or at risk from, mixed parasitic infections:
Għall- klieb li qed isofru minn, jew huma fil- periklu t´ infezzjonijiet kawżati minn parassiti diversi:
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Għat- trattament u għall- prevenzjoni ta´ mard tal- briegħed (Ctenocephalides felis), trattament għal - qamel li jigdem (Trichodectes canis), trattament għall- infezzjoni tad- dudu tal- widna (Otodectes cynotis) sarkoptik mange (ikkawżata minn Sarcoptes scabiei var canis), domodikosis (ikkawżata minn Demodex canis), prevenzioni ta´ mard tad- dudu tal- qalb (larva L3 u L4 tad- Dirofilaria immitis), trattament ta’ Angiostrongylus vasorum u t- trattament ta´nfezzjonijiet ta´ħniex gastro- intestinali (larva L4, adulti mmaturi u maturi tat - Toxocara canis u Ancylostoma caninum u Unicinaria stenocephala,
9 4.3 Contraindications
9 Dan il- prodott fih il- moksidektin (laktonju makroċikliku), għalhekk, adulti tat - Toxascaris leonina u Trichuris vulpis).
Do not use in puppies under 7 weeks of age.
Tużax fuq ġriewi li huma iżgħar minn 7 ġimgħat.
For cats, the corresponding “ Advocate for cat ” product, which contains 100 mg/ ml imidacloprid and 10 mg/ ml moxidectin, must be used.
Għall - qtates għandu jintuża il- prodott apposta għalihom “ Advocate għall- qtates ”, li fih 100 mg/ ml Imidakloprid u 10 mg/ ml Moksidektin.
4.4 Special warnings
4. 4 Twissijiet speċjali < għal kull speċi li għaliha hu indikat il- prodott >
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Resistenza tal- parassita għal xi klassi partikulari ta´sustanza kontra d- dud tista´tiżviluppa wara li jsir użu frekwenti u repetut ta´din is- sustanza ta´din il- klassi.
There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a risk-benefit assessment for these animals.
Hemm esperjenza limita fuq l- użu tal- prodott fuq annimali morda u debboli, għalhekk il- prodott m´għandux jiġi wżat fuq bażi ta´ valutazzjoni tar- riskju u benefiċċju fuq dawn l- annimali.
When the product is applied in 3 to 4 separate spots (see section 4.9), specific care should be taken to prevent the animal licking the application sites.
Meta l- prodott jiġi applikat fuq 3 jew 4 partijiet differenti (ara sezzjoni 4. 9), għandha tingħata attenzjoni speċjali biex tevita li l- annimal jilgħaq il- partijiet t´applikazzjoni.
This product contains moxidectin (a macrocyclic lactone), therefore special care should be taken with Collies, Old English Sheepdogs and related breeds or crossbreeds, to correctly administer the product as described under section 4.9; in particular, oral uptake by the recipient and/ or other animals in close contact should be prevented.
Dan il- prodott fih il- moksidektin (laktonju makroċikliku), għalhekk għandha tingħata attenzjoni speċjali fuq klieb tar- razza Collies, Old English Sheepdogs u razzez simili jew taħlit ta´razzez simili, biex il- prodott jiġi amministrat kif spjegat fis- sezzjoni 4. 9 (doża) ¸ partikularment għandu jiġi evitat li annimali trattati / jew annimali oħra li jiġu f ’ kuntatt magħhom, jilgħaqu l- mediċina.
Advocate should not be allowed to enter surface waters as it has harmful effects on aquatic organisms: moxidectin is highly toxic to aquatic organisms.
Advocate ma għandu qatt jitħalla jmur man- nixxiegħat ta´ l- ilma minħabba li jista´jkun ta´periklu għall- ħut jew ħlejqiet oħra akwatici:
Dogs should not be allowed to swim in surface waters for 4 days after treatment.
Moksidektin huwa velenuż ħafna għall- ħlejqiet akwatiċi.
Although the product may be safely administered to dogs infected with adult heartworms, it has no therapeutic effect against adult Dirofilaria immitis.
Għalkemm il- prodott jista´jiġi użat mingħajr periklu fuq klieb li huma nfettati bil- marda tad- dudu tal - qalb adult, dan m´għandux effet terapewtiku kontra Dirofilaria immitis adulti.
It is therefore recommended that all dogs 6 months of age or more, living in areas endemic for heartworm, should be tested for existing adult heartworm infection before being treated with the product.
Huwa għalhekk rikommandat illi l- klieb li għandhom minn 6 xhur l´fuq, u li joqgħodu f´postijiet fejn igħix id- dudu tal- qalb, jiġu eżaminati għall- infezzjoni tad- dud tal- qalb adulti qabel jigu trattati bil- prodott.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
10 Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali veterinarju lill- annimali
10 People with a known hypersensitivity to either benzyl alcohol, imidacloprid or moxidectin should administer the product with caution.
Tmellisx jew tippetna l- annimal wara l- applikazzjoni qabel ma ’ tinxef il- parti fejn tapplika Nies li għandhom sensittivita kbira kemm għall- benzyl alcohol Imidakloprid u Moksidektin għandhom jamministraw il- prodott b´kawtela.
Use of the product may result in transient pruritus in dogs.
L- użu tal- prodott jista´jikkawża prurite li jgħaddi, fuq il- klieb.
On rare occasions greasy hair, erythema and vomiting can occur.
F´okkażjonijiet rari jista´ jikkawża pil żejtni, eritema u jista´jikkawża wkoll rriġettar.
These signs disappear without further treatment.
Dawn is- sinjali jisparixxu mingħajr ma jsir xi trattament.
If the animal licks the application site after treatment, transient neurological signs may be observed infrequently (see section 4.10 –).
Il- prodott jista` f’ każijijiet rari, jikkawża reazzjonijiet lokali sensittivi ħafna. Jekk l- annimal jilgħaq il- post ta´l- applikazzjoni wara t- trattament, sintomi newroloġici li jgħaddu, jistgħu jiġu kultant osservati (ara sezzjoni 4. 10).
The product tastes bitter.
Il- prodott għandu togħma morra.
Salivation may occasionally occur if the animal licks the application site immediately after treatment.
Bżieq jista´ jifforma kultant jekk l- annimal jilgħaq il- post t´applikazzjoni hekk kif jiġi trattat.
This is not a sign of intoxication and disappears within some minutes without treatment.
Dan m´huwiex sinjal t’ intoksikazzjoni u tisparixxi fi ftit minuti mingħajr xi trattament.
Correct application will minimise licking of the application sites.
Jekk il- prodott jiġi applikat tajjeb, inqas jista´ jilgħaq l- annimal il- post t´applikazzjoni.
Use only according to the risk-benefit assessment by the responsible veterinarian.
Studji fil- laboratorju bl- użu t´Imidakloprid u Moksidektin fuq il- far u l- fniek ma pprovdewx evidenza ta 'ħsara fit- tqala, ħsara lill- fetu jew ħsara lill- omm Uża biss skond il- valutazzjoni tar- riskju u benefiċċju tal- veterinarju responsabbli..
No interactions between Advocate and routinely used veterinary medicinal products or medical or surgical procedures have been observed.
L- ebda reazzjoni ma ġiet osservata meta l- Advocate jintuża flimkien ma kwalunkwe prodott ieħor li jingħata regolari, jew proċeduri mediċinali jew kirurġici.
The recommended minimum doses are 10 mg/ kg bodyweight imidacloprid and 2.5 mg/ kg bodyweight moxidectin, equivalent to 0.1ml/ kg bodyweight Advocate for dogs.
Id- dożi minimi rrikkmandati huma ta´10 mg Imidakloprid għal kull kg użin tal- ġisem. u 2. 5 mg Moksidektin għal kull kg użin tal- ġisem, li jiġu ekwivalenti għal 0. 1 ml Advocate għall- klieb, għal kull kg użin tal- ġisem.
The treatment schedule should be based on the local epidemiological situation.
11 L- iskeda ta´ trattament għandha tiġi bbażata fuq il- sitwazzjoni epidemjoloġika.
Weight of dog [kg]
kelb [kg]
Pipette size to be used
[mg/ kg użin tal - ġisem]
Volume Imidacloprid Moxidectin [ml] [mg/ kg bw] [mg/ kg bw]
[mg/ kg użin tal - ġisem]
≤ 4 kg
≤ 4kg
Advocate for small dogs
Advocate għall- klieb żgħar
minimum of minimum of 10 2.5
Advocate għall- klieb ta´qies medju
> 4 – 10 kg Advocate for medium dogs > 10 – 25 kg Advocate for large dogs > 25 – 40 kg Advocate for extra-large dogs
10- 25
1.0 2.5 4.0
2. 5- 6. 25
10 - 25 10 - 25 10 - 16
10- 25 10- 16
2.5 - 6.25 2.5 – 6.25 2.5 - 4
2. 5- 6. 25 2. 5- 4
The product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.
Il- prodott għandu jigi amministrat f´ intervalli ta´xahar meta jiġi użat bħala parti mill- istrateġija għall- kura ta´dermatite kawżata minn allerġija għall- briegħed.
Treatment of biting lice (Trichodectes canis)
Trattament tal- qamel li jigdem (Trichodectes canis)
A single dose should be administered.
Doża waħda għandha tiġi amministrata.
A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Huwa rrikmandat li ssir vista oħra mill- veterinarju wara 30 ġurnata mill- ewwel trattament peress li jista ’ jkun hemm xi annimali li jkollhom bżonn it- tieni trattament.
Treatment of ear mite infestation (Otodectes cynotis)
Trattament ta ’ l- infezzjoni tad- dudu tal- widna (Otodectes cynotis)
A single dose of the product should be administered.
Doża waħda tal- prodott għandha tiġi amministrata.
Loose debris should be gently removed from the external ear canal at each treatment.
Frak li jista ’ jibqa għandu jiġi mneħhi mill- parti ta ’ barra tal- kanal tal- widna ma ’ kull trattament.
A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Eżami ieħor minn veterinarju għandu jsir 30 ġurnata wara li jiġi rrikmandat peress li biċċa mill- l- annimali jirrikjedu t- tieni trattament.
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis)
Canis)
A single dose should be administered twice 4 weeks apart.
Doża waħda għandha tiġi amministrata darbtejn – it- tieni doża wara 4 ġimgħat.
Treatment of demodicosis (caused by Demodex canis)
Trattament ta ’ domodikosis (ikkawżata minn Demodex canis)
A single dose administered 2 to 4 times at 4 weekly intervals is efficacious against Demodex canis and leads to a marked improvement of clinical signs.
Doża waħda amminstrata minn 2 sa 4 darbiet b’ intervalli ta ’ 4 ġimgħat taħdem kontra Demodex canis u twassal għal- titjib fis- sinjali kliniċi.
As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Billi demodikosis hija marda b’ ħana fatturi, huwa rrikmandat fejn possibli, li titratta wkoll xi marda li hija konnessa kif jeħtieġ.
Heartworm prevention
Prevenzjoni tad- dudu tal- qalb.
Dogs in areas endemic for heartworm, or those which have travelled to endemic areas, may be infected with adult heartworms.
Klieb li jgħixu jew li jiġu meħuda f´postijiet fejn jgħix id- dudu tal- qalb, jistgħu jkunu nfettati bid- dud tal- qalb adulti.
For prevention of heartworm disease, the product must be applied at regular monthly intervals during the time of the year when mosquitoes (the intermediate hosts which carry and transmit heartworm larvae) are present.
Għall- prevenzjoni tal- marda tad- dudu tal- qalb, il- prodott għandu jiġi applikat regularment f´intervalli ta´xahar, waqt iż- żmien tas- sena meta n- nemus (li permezz tagħhom jinġarru u jinfirxu l- larva tad- dud tal- qalb) huma preżenti.
The product may be administered throughout the year or at least 1 month before the first expected exposure to mosquitoes.
Il- prodott jista´jiġi amministrat matul is- sena kollha jew ta´ l- inqas xahar
Treatment should continue at regular monthly intervals until 1 month after the last exposure to mosquitoes.
12 qabel l- ewwel espożizzjoni mistennija ta´nemus.
In non-endemic areas there should be no risk of dogs having heartworm.
F´postijiet fejn ma jgħix id- dudu tal- qalb, m´għandux ikun hemm riskju li l- klieb jieħdu d- dudu tal - qalb.
Treatment of Angiostrongylus vasorum
Trattament ta ’ Angiostrogylus vasorum
Roundworm, hookworm and whipworm treatment
Trattament għall- ħniex
12 In areas endemic for heartworm, monthly treatment may significantly reduce the risk of re-infection caused by the respective round-, hook- and whipworms.
F´postijiet fejn jgħix id- dudu tal- qalb, trattament ta´ kull xahar inaqqas ir- riskju li jerġa jkun hemm infezzjoni kkaġunata speċjalment mill- ħniex.
In areas non-endemic for heartworm, the product can be used as part of a seasonal prevention programme against fleas and gastrointestinal nematodes.
F´postijiet li mhumiex endemiċi għad- dudu tal- qalb, il - prodott jista´ jiġi wżat bħala programm ta´ prevenzjoni kontra l- briegħed u ħniex gastro- intestinali.
Studies have shown that monthly treatment of dogs will prevent infections caused by Uncinaria stenocephala.
Studji juru li l- kura ta´ kull xahar fuq il- klieb tipprevedi infezzjonijiet ikkawżati minn Uncinaria stenocephala.
For dogs up to 25 kg:
Għall- klieb li jiżnu sa 25 kg:
With the dog in a standing position, part the coat between the shoulder blades until the skin is visible.
Bil- kelb f´qaghda wieqfa, ofroq il- pil bejn l- għadam ta´l- ispallal sakemm tidher il- ġilda.
Place the tip of the pipette on the skin and squeeze the pipette firmly several times to empty its contents directly onto the skin.
Jekk possibli applika fuq ġilda ntatta Poġġi t- tarf tal- pipetta fuq il- ġilda u għafas il- pipetta bis- sħiħ kemm il- darba biex tbattal il- kontenut direttament fuq il- ġilda.
For dogs of more than 25 kg:
Għall- klieb li jiżnu aktar minn 25 kg:
The entire contents of the pipette should be applied evenly as 3 or 4 spots along the top of the back, from between the shoulders to the base of the tail.
Biex l- applikazzjoni tkun faċli, il- kelb għandu jkun f´qagħda wieqfa. Il- kontenut kollu tal- pipetta għandu jiġi applikat bl- istess ammont fuq tlieta jew erba´ partijiet fuq id- dahar tal- kelb, minn bejn l - ispallel sa fejn jibda d- denb.
At each spot, part the coat until the skin is visible.
Fuq kull parti, ofroq il- pil sakemm tidher il- ġilda.
Wherever possible apply to undamaged skin.
Jekk possibli applika
Place the tip of the pipette on the skin and gently squeeze the pipette to expel a portion of its contents directly onto the skin.
13 fuq ġilda ntatta Poġġi t- tarf tal- pipetta fuq il- ġilda u għafas bil- mod il- pipetta biex toħroġ ftit mill - kontenut direttament fuq il- ġilda.
Do not apply an excessive amount of solution at any one spot, as that could cause some of the product to run down the animal’ s side.
Tapplikax ammont eċċessiv tat- taħlita fuq parti waħda tal- ġisem, għaliex hekk it- taħlita tista´ ċċarċar mal- ġnub.
13 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti) jekk ikun hemm bżonn
Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs.
Id- doża rrikmandata ġiet ittollerata sa 10 darbiet mill - klieb kbar, mingħajr l- ebda evidenza t´effetti avversarji jew sinjali klinici mhux mixtieqa.
The product was administered to puppies at up to 5 times the recommended dose, every 2 weeks for 6 treatments, and there were no serious safety concerns.
Il- prodott ġie amministrat sa 5 darbiet bid- doża rrikkmandata fuq ġriewi kull ġimgħatejn għal- 6 trattamenti, u ma kienx hemm affari serji ta´sigurta´ Midriasi li tgħaddi, tbeżzieq, irreġettar u respirazzjoni mgħaġġla li tgħaddi ġew osservati.
After accidental oral ingestion, transient neurological signs such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may occur infrequently.
Wara li l- prodott jittieħed aċcidentalment orali, sintomi newroloġiċi li jgħaddu bħal għejja, tregħid ma´kullimkien, sinjali fl- għajnejn (twessiegħ fit- toqba tal- mamma tal- għajn, ftit akkomodazzjoni ta´l - għajn, oxxillazzjoni kontinwa waħda ġo l- oħra tal- boċċi tal- għajnejn), respirazzjoni li mhix normali, tbeżżieq u rriġettar jistgħu jsiru, mhux ta´spiss.
Ivermectin-sensitive Collie dogs tolerated up to 5 times the recommended dose without any adverse effects.
Klieb tar- razza tal- Collie sensitivi għall- vermettina ttolerraw id- doża rrikommandata sa 5 darbiet mingħajr affetti avversarji.
However, when 40% of the unit dose was given orally, severe neurological signs were observed.
Imma, meta 40% ġiet mogħtija oralment, sinjali newroloġiċi ġew osservati.
Oral administration of 10% of the recommended dose produced no adverse effects.
Amministrazzjoni orali ta´10% tad- doża rrikommandata ma ħalliet l´ebda effetti avversarji.
Dogs infected with adult heartworms tolerated up to 5 times the recommended dose, every 2 weeks for 3 treatments, without any adverse effects.
Klieb infettati bid- dud tal- qalb adult, ittolleraw id- doża rrikommandata sa 5 darbiet, kull gimagħtejn għal 3 trattamenti, mingħajr affetti avversarji.
Flea larvae in the pet’ s surroundings are killed after contact with a pet treated with the product.
Briegħed fi stat ta´ larva li jkunu fl- inħawi fejn ikun qiegħed l - annimal, jiġu meqruda wara li jiġu f´kuntatt ma´l- annimal li jkun itrattat bil- prodott.
Imidacloprid has a high affinity for the nicotinergic acetylcholine receptors in the post-synaptic region of the central nervous system (CNS) of the flea.
Imidakloprid għandu affinita´ kbira fuq it- tessut/ organu li jirrispondi għall - Aċetilkolina Nikotinerġika fir- reġjun post sinaptiku tas- sistema nervuża ċentrali tal- bergħud.
The ensuing inhibition of cholinergic transmission in insects results in paralysis and death.
In- nuqqas ta´ trasmissjoni kolinerġika li jiġi kkaġunat fuq l- insett, jipparalizza u joqtol l- insett.
Imidacloprid has minimal pharmacological activity in mammals.
Minħabba li l- effett ta´ l - Imidakloprid fuq t - tessuti/ organi, li jirrispondu għal sustanzi nikotinerġiċi fuq l- annimali li jreddgħu, huwa żgħir ħafna. u l- penetrazzjoni meħtieġa fil- blood- brain barrier ta´l- annimali li jreddgħu hija żgħira ħafna, dan
Moxidectin, 23-(O-methyloxime)-F28249 alpha is a second-generation macrocyclic lactone of the milbemycin family.
14 m´għandux effett fuq is- sistema ċentrali ta´l- annimali li jreddgħu.
It is a parasiticide which is active against many internal and external parasites.
Imidakloprid għandu effet farmakoloġiku minimali fuq l- annimali li jreddgħu.
Moxidectin is active against larval stages (L3, L4) of Dirofilaria immitis.
Moksidektin, 23 - (O- metiloksim) - F28249 alpha huwa lattonju makroċikliku tat- tieni ġenerazzjoni mill - familja ta´mibelmiċin. Din hija parassita li taħdem kontra ħafna parassiti interni u esterni. Moksidektin taħdem kontra stadji tal- larva (L3, L4) tad- Dirofilaria immitis.
It is also active against gastrointestinal nematodes.
Hija taħdem ukoll kontra ħniex gastro - intestinali.
This leads to opening of the chloride channels on the postsynaptic junction, the inflow of chloride ions and induction of an irreversible resting state.
Dan jikkaġuna l- ftuħ tal- kanali tal- kloru ta´ l- għaqda post sinaptika, d- dħul ta´jone tal- kloru u l - induzzjoni ta´stat ta´mistrieħ irriversibbli.
After topical administration of the product, imidacloprid is rapidly distributed over the animal’ s skin within one day of application.
Wara li tkun saret amministrazzjoni topikali tal- prodott, Imidakloprid jinfirex malajr fuq il- ġilda ta´ l - annimal fi żmien ġurnata meta jiġi applikat.
It can be found on the body surface throughout the treatment interval.
Imidakloprid jista´jinstab fuq il - parti ta´ barra tal- ġisem matul iż- żmien tat- trattament.
Moxidectin is absorbed through the skin, reaching maximum plasma concentrations approximately 4 to 9 days after treatment in dogs.
Moksidektin igħaddi minn ġol- ġilda, u jilħaq konċentrazzjoni massima fil- plasma, bejn wieħed u ieħor minn 4 sa 9 t´ ijiem wara trattament fuq il- klieb.
Following absorption from the skin, moxidectin is distributed
Wara li jgħaddi għal ġol- ġilda, Moksidektin jinfirex b´mod sistematiku u jiġi mneħħi bil- mod mill- plasma.
14 systemically and is slowly eliminated from the plasma as manifested by detectable moxidectin concentrations in plasma throughout the treatment interval of one month.
Dan jintwera biċ- ċar fil- konċentrazzjoni ta´ Moksidektin fil- plasma li tista´tiġi eżaminata, matul iż- żmien tat - trattament ta´xahar.
See sections 4.5. and 6.6
Ara sezzjoni 4. 5 u 6. 6
0.4 ml, 1.0 ml, 2.5 ml and 4.0 ml per pipette
0. 4 ml, 1. 0ml, 2. 5ml u 4. 0 ml kull pipetta
Not all pack sizes may be marketed.
15 Jista´ jkun li mhux id- daqs tal- pakketti kollha jista´qegħdin fis- suq.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA (/ BIOLOĠIĊI) ATTIVA( I) U SID/ S- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ 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
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA ’ L - AWTORIZZAZZJONI TAL- KUMMERĊ DWAR L- UŻU SIGUR U EFFETTIV
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTURA( I) TAS- SUSTANZA( I) BIOLOĠIKA( ĊI) ATTIVA( I) U SID (/ S- SIDIEN TA ’) L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str.
KVP Pharma + Veterinär Produkte GmbH Projjensdorfer Str.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR IL- PROVISTA U L- UŻU
Veterinary medicinal product subject to prescription.
Sabiex jiġu mogħtija biss bi preskrizzjoni veterinarja.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Is- sid ta ’ l- awtorizzazzjoni tal- manifattura għandu jinforma lill- Kommissjoni Ewropeja fuq pjanijiet ta ’ manifattura għall- prodott mediċinali awtorizzat b’ din id- deċiżżjoni.
Not applicable.
Mhux appklikabbli
LABELLING AND PACKAGE LEAFLET
TIKETTA U L- FULJETT TA ’ TAGĦRIF FIL- PAKETT
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Advocate spot-on solution for small cats Outer carton, pack size of 3, 4, 6, 21 and 42 pipettes.
20 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Advocate – taħlita likwida għal użu lokalizzat fuq qtates żgħar Pakkett ta´ barra, pakkett ta´ 3, 4, 6, 21 u 42 pipetti.
Advocate spot-on solution for small cats
Advocate – taħlita likwida għal użu lokalizzat fuq il- friegħ tal- qtates
Each 0.4 ml pipette contains:
Kull pipetta ta´0. 4ml fiha:
40 mg imidacloprid, 4 mg moxidectin Benzyl alcohol 1 mg/ ml butylhydroxytoluene (E321: as antioxidant)
40 mg Imidakloprid, 4mg Moksidektin Benzyl alchol 1 mg/ ml butylhydroxytoluene (E321: bħala antiossidant)
Spot-on solution
Taħlita għal użu lokalizzat
For small cats weighing 4 kg or less
Għall- qtates żgħar li jiżnu 4 kg jew inqas
For cats suffering from, or at risk from, mixed parasitic infections:
Għal qtates li jsofru, jew qegħdin fir- riskju t´ infezzjonijiet kawżati minn parassiti diversi:
For the treatment and prevention of flea infestation (Ctenocephalides felis), treatment of ear mite infestation (Otodectes cynotis), prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis) and treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara cati and Ancylostoma tubaeforme).
Għat- trattament u għall- prevenzjoni ta´ mard tal- briegħed (Ctenocephalides felis), trattament ta ’ l - infezzjoni tal - dudu tal- widna (Otodectes cynotis) prevenzjoni ta´ mard tad- dud tal- qalb (larva L3 u L4 tad- Dirofilaria immitis) u t- trattament ta´nfezzjonijiet ta´ħniex gastro- intestinali (larva L4, adulti mmaturi u maturi tat- Toxocara cati u Ancylostoma tubaeforme).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Il- prodott jista´jiġi wżat bħala parti mill- istrateġija ta´ trattament tad- dermatite kawżata mill- allerġija tal- briegħed.
For external use only.
Għal użu estern biss.
Read the package leaflet before use.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett.
[Not applicable]
[mhux applikabbli]
Read the package leaflet before use.
Aqra l- fuljett ta 'tagħrif fil- pakkett qabel tuża.
Do not use in kittens under 9 weeks of age.
Tużax fuq friegħ ta´qtates iżgħar minn 9 ġimgħat.
Consult your veterinarian before using the product on pregnant or lactating cats, or on sick or debilitated cats, or on cats under 1 kg.
Saqsi l- veterinarju tiegħek qabel tuża l- prodott fuq qtates ħbiela jew li qed jaħilbu, jew fuq qtates morda jew debboli, jew fuq qtates li jiżnu inqas minn 1 kg.
EXP {month/ year}
Jiskadi {xahar/ sena}
Do not store above 30 °C
Taħżinx f' temperatura l- fuq minn 30°C
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Advocate should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
Advocate ma għandu qatt jitħalla jmur man- nixxiegħat tal- ilma minħabba li jista´ jkun ta 'periklu għall - ħut jew ħlejqiet oħra akwatiċi.
For animal treatment only - to be supplied only on veterinary prescription.
Għal Trattament ta ’ l- Annimali Biss għandu jingħata biss bi preskrizzjoni medika.
Bayer Animal Health GmbH, D-51368 Leverkusen, Germany
Bayer Animal Health GmbH, D- 51368 Leverkusen, Germany
3 pipettes 6 pipettes 4 pipettes 21 pipettes
3 pipetti 6 pipetti
EU/ 2/ 03/ 039/ 020
EU/ 2/ 03/ 039/ 013 EU/ 2/ 03/ 039/ 019 EU/ 2/ 03/ 039/ 020
42 pipettes
4 pipetti 21 pipetti 42 pipetti
Flea
Bergħud
Larvae
Larvae
Hookworm
Ħniex fl- imsaren
Roundworm
Ħniex fl- imsaren
Heartworm
Dudu tal- qalb
23 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Advocate spot-on solution for large cats Outer carton, pack size of 3, 4, 6, 21 and 42 pipettes.
23 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Advocate – taħlita likwida għal użu lokalizzat fuq qtaters kbar Pakkett ta´ barra, pakkett ta´ 3, 4, 6, 21 u 42 pipetti.
Advocate spot-on solution for large cats
Advocate – taħlita likwida għal użu lokalizzat fuq qtaters kbar
Each 0.8 ml pipette contains:
Kull pipetta ta´0. 8ml fiha:
80 mg imidacloprid, 8 mg moxidectin Benzyl alcohol 1 mg/ ml butylhydroxytoluene (E321: as antioxidant)
80 mg Imidakloprid, 8 mg Moksidektin Benzyl alcohol 1 mg/ ml butylhydroxytoluene (E321: bħala antiossidant)
For large cats weighing between 4 kg and 8 kg
Għall- qtates li jiżnu minn 4 kg sa 8 kg
For the treatment and prevention of flea infestation (Ctenocephalides felis), treatment of ear mite infestation (Otodectes cynotis), prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis) and treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara cati and Ancylostoma tubaeforme).
Għat- trattament u għall- prevenzjoni ta´ mard tal- briegħed (Ctenocephalides felis), trattament ta ’ l - infezzjoni tad- dudu tal- widna (Otodectes cynotis) prevenzjoni ta´ mard tad- dud tal- qalb (larva L3 u L4 tad- Dirofilaria immitis) u t- trattament ta´nfezzjonijiet ta´ħniex gastro- intestinali (larva L4, adulti mmaturi u maturi tat- Toxocara cati u Ancylostoma tubaeforme).
Read the package leaflet before use.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
EU/ 2/ 03/ 039/ 003 EU/ 2/ 03/ 039/ 004 EU/ 2/ 03/ 039/ 014 EU/ 2/ 03/ 039/ 021
EU/ 2/ 03/ 039/ 003
3 pipettes 6 pipettes 4 pipettes 21 pipettes
3 pipetti
EU/ 2/ 03/ 039/ 022
EU/ 2/ 03/ 039/ 004 EU/ 2/ 03/ 039/ 014 EU/ 2/ 03/ 039/ 021 EU/ 2/ 03/ 039/ 022
42 pipettes
6 pipetti 4 pipetti 21 pipetti 42 pipetti
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Advocate spot-on solution for small dogs Outer carton, pack size of 3, 4, 6, 21 and 42 pipettes.
26 T TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Advocate – taħlita likwida għal użu lokalizzat fuq klieb żgħar Pakkett ta´ barra, pakkett ta´ 3, 4, 6, 21 u 42 pipetti.
Advocate spot-on solution for small dogs
Advocate – taħlita likwida għal użu lokalizzat fuq klieb żgħar
Benzyl alcohol 1 mg/ ml butylhydroxytoluene (E321: as antioxidant)
40 mg Imidakloprid, 10 mg Moksidektin Bezyl alcohol 1 mg/ ml butylhydroxytoluene (E321: bħala antiossidant)
For small dogs weighing 4 kg or less
Għall - klieb żgħar li jiżnu 4 kg jew inqas
For the treatment and prevention of flea infestation (Ctenocephalides felis), treatment of biting lice (Trichodectes canis), treatment of ear mite infestation (Otodectes cynotis), sarcoptic mange (caused by Sarcoptes scabiei var. canis), demodicosis (caused by Demodex canis), prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis), treatment of Angiostrongylus vasorum and treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala, adults of Toxascaris leonina and Trichuris vulpis).
Għat- trattament u għall- prevenzjoni ta´ mard tal- briegħed (Ctenocephalides felis), trattament tal - qamel li jigdem (Trichodectes canis), trattament ta ’ l- infezzjoni tad- dudu tal- widna (Otodectes cynotis) sarkoptik mange (ikkawżata minn Sarcoptes scabiei var. canis), domodikosis (caused by Demodex canis), prevenzioni ta´ mard tad- dudu tal- qalb (larva L3 u L4 tad- Dirofilaria immitis), trattament ta ’ Angiostrongylus vasorum u t- trattament ta´nfezzjonijiet ta´ħniex gastro- intestinali (larva L4, adulti mmaturi u maturi tat - Toxocara canis u Ancylostoma caninum u Unicinaria stenocephala, adulti tat - Toxascaris leonina u Trichuris vulpis).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Il- prodott jista´jiġi wżat bħala parti mill- istrategija ta´trattament tad- dermatite kawżata mill- allerġija tal- briegħed.
27 Read the package leaflet before use.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
Do not use in puppies under 7 weeks of age.
Tużax fuq griewi iżgħar minn 7 ġimgħat.
Consult your veterinarian before using the product on pregnant or lactating bitches, or on sick or debilitated dogs, or on dogs under 1 kg.
Saqsi l- veterinarju tiegħek qabel tuża l- prodott fuq klieb ħbiela jew li qed jaħilbu, jew fuq klieb morda jew debboli, jew fuq klieb li jiżnu inqas minn 1 kg.
4 pipettes 21 pipettes 42 pipettes
3 pipetti 6 pipetti 4 pipetti 21 pipetti 42 pipetti
Whipworm
Whipworm
Louse
Qamla
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Advocate spot-on solution for medium dogs Outer carton, pack size of 3, 4, 6, 21 and 42 pipettes.
29 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Advocate – taħlita likwida għal użu lokalizzat fuq klieb ta´ kobor medju Pakkett ta´ barra, pakkett ta´ 3, 4, 6, 21 u 42 pipetti.
Advocate spot-on solution for medium dogs
Advocate – taħlita likwida għal użu lokalizzat fuq klieb ta´ kobor medju
Each 1 ml pipette contains:
Kull pipetta ta´1 ml fiha:
Benzyl alcohol 1 mg/ ml butylhydroxytoluene (E321: as antioxidant)
100 mg Imidakloprid, 25 mg Moksidektin Benzyl alcohol 1 mg/ ml butylhydroxytoluene (E321: bħala antiossidant)
For medium dogs weighing between 4 kg and 10 kg
Għall- klieb ta´kobor medju li jiżnu minn 4 kg sa 10kg
30 Read the package leaflet before use.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
6 pipettes 4 pipettes 21 pipettes 42 pipettes
3 pipetti 6 pipetti 4 pipetti 21 pipetti 42 pipetti
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Advocate spot-on solution for large dogs Outer carton, pack size of 3, 4, 6, 21 and 42 pipettes.
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Advocate – taħlita likwida għal użu lokalizzat fuq klieb kbar Pakkett ta´ barra, pakkett ta´ 3, 4, 6, 21 u 42 pipetti.
Advocate spot-on solution for large dogs
Advocate – taħlita likwida għal użu lokalizzat fuq klieb kbar
Each 2.5 ml pipette contains:
Kull pipetta ta´ 2. 5 ml fiha:
Benzyl alcohol 1 mg/ ml butylhydroxytoluene (E321: as antioxidant)
250 mg Imidakloprid, 62. 5 mg Moksidektin Benzyl alcohol 1 mg/ ml butylhydroxytoluene (E321: bħala antiossidant)
For large dogs weighing between 10 kg and 25 kg
Għall- klieb kbar li jiżnu minn 10 kg sa 25 kg
33 Read the package leaflet before use.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Advocate spot-on solution for extra-large dogs Outer carton, pack size of 3, 4, 6, 21 and 42 pipettes.
35 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Advocate – taħlita likwida għal użu lokalizzat fuq klieb kbar ħafna Pakkett ta´ barra, pakkett ta´ 3, 4, 6, 21 u 42 pipetti.
Advocate spot-on solution for extra-large dogs
Advocate – taħlita likwida għal użu lokalizzat fuq klieb kbar ħafna
Each 4 ml pipette contains:
Kull pipetta ta´ 4 ml fiha:
Benzyl alcohol 1 mg/ ml butylhydroxytoluene (E321: as antioxidant)
400 mg Imidakloprid, 100 mg Moksidektin Benzyl alcohol 1 mg/ ml butylhydroxytoluene (E321: bħala antiossidant)
For extra-large dogs weighing between 25 kg and 40 kg
Għall- klieb kbar ħafna li jiżnu minn 25 kg sa 40 kg
36 Read the package leaflet before use.
Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
38 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Advocate for small cats Pipette label
38 ĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR Advocate għal qtates żgħar Tikketta tal- pipetta
Advocate for cats
Advocate għal qtates
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
KONTENUT BĦALA PIŻ, VOLUM JEW NUMRU TA 'DOŻI
ROUTE(S) OF ADMINISTRATION
MOD TA AMMINISTRAZZJONI
Spot-on
Użu lokalizzat
{month/ year}
Jiskadi {xahar/ sena}
39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Advocate for large cats Pipette label
39 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR Advocate għal qtates kbar Tikketta tal- pipetta
40 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Advocate for small dogs Pipette label
40 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR Advocate għal klieb żgħar Tikketta tal- pipetta
Advocate for dogs
Advocate għal klieb
41 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Advocate for medium dogs Pipette label
41 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR Advocate għal klieb ta´kobor medju Tikketta tal- pipetta
42 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Advocate for large dogs Pipette label
42 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR Advocate għal klieb kbar Tikketta tal- pipetta
43 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Advocate for extra-large dogs Pipette label
43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR Advocate għal klieb kbar ħafna Tikketta tal- pipetta
44 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
44 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI Advocate – taħlita likwida għal qtates żgħar
Advocate for small cats
Advocate għal qtates żgħar
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
KONTENUT BL- UŻIN, VOLUM JEW NUMRU TA´ DOŻA
45 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
45 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI Advocate – taħlita likwida għal qtates kbar
Advocate for large cats
Advocate għal qtates kbar
46 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
46 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI Advocate – taħlita likwida għal klieb żgħar
Advocate for small dogs
Advocate għal klieb żgħar
47 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
47 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI Advocate – taħlita likwida għal klieb ta´ kobor medju
Advocate for medium dogs
Advocate għal klieb ta´ kobor medju
48 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
48 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI Advocate – taħlita likwida għal klieb kbar
Advocate for large dogs
Advocate għal klieb kbar
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS
49 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI Advocate – taħlita likwida għal klieb kbar ħafna
Advocate for extra-large dogs
Advocate għal klieb kbar ħafna
PACKAGE LEAFLET
FULJETT TA 'TAGĦRIF FIL- PAKKETT
51 PACKAGE LEAFLET Advocate spot-on solution for cats
51 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Advocate għal qtates
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
1 L- ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- KUMMERĊ, U L - ISEM U L- INDIRIZZ TAS- SID TAL- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
Bayer Animal Health GmbH 51368 Leverkusen Germany
Sid l- Awtorizzazzjoni tal- Kummerċ Bayer Animal Health GmbH D- 51368 Leverkusen Germany
Manufacturer for the batch release:
Manifattur li jħalli l- konsenja tmur fis- suq:
324, 24106 Kiel Germany
324, D- 24106 Kiel Germany
Each unit dose pipette delivers:
Kull doża waħda tagħti:
Advocate for small cats (≤ 4 kg) Advocate for large cats (> 4-8 kg)
Advocate għall- qtates żgħar (≤ 4 kg) Advocate għall- qtates kbar (> 4- 8 kg)
Benzyl alcohol, 1 mg/ ml butylhydroxytoluene (E 321; as antioxidant)
Benzyl alcohol 1 mg/ ml butylhydroxytoluene (E321; bħala antiossidant)
For cats suffering from, or at risk from, mixed parasitic infections:
Għal qtates li jsofru, jew qegħin fir- riskju t´ infezzjonijiet kawżati minn parassiti diversi:
For the treatment and prevention of flea infestation (Ctenocephalides felis), treatment of ear mite infestation (Otodectes cynotis), prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis) and treatment of infections with gastrointestinal nematodes (L4 larvae, immature adults and adults of Toxocara cati and Ancylostoma tubaeforme).
Għat- trattament u għall- prevenzjoni ta´ mard tal- briegħed (Ctenocephalides felis), trattament ta ’ l - infezzjoni tad- dudu tal- widna (Otodectes cynotis), prevenzioni ta´ mard tad- dud tal- qalb (larva L3 u L4 tad- Dirofilaria immitis) u t- trattament ta´nfezzjonijiet ta´ħniex gastro- intestinali (larva L4, adulti mmaturi u maturi tat- Toxocara cati u Ancylostoma tubaeforme).
The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Il- prodott jista´jiġi wżat bħala parti mill- istrateġija ta´trattament tad- dermatite kawżata mill- allerġija tal- briegħed.
52 produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
52 Il- Ħarsien tas- Saħħa tal- Prodott mediċinali veterinarju ma ġiex stabbilit waqt it- tqala u fi żmien il - ħalib.
Use only according to the risk-benefit assessment by the responsible veterinarian.
Uża biss skond il- valutazzjoni tar - riskju u benefiċċju tal- veterinarju responsabbli..
If the animal licks the application site after treatment, transient neurological signs such as ataxia, generalised tremors, ocular signs (dilated pupils, little pupillary reflex, nystagmus), abnormal respiration, salivation and vomiting may occur infrequently.
Il- prodott jista` f’ każijijiet rari, jikkawża reazzjonijiet lokali sensittivi ħafna. Jekk l- annimal jilgħaq il- post ta´l- applikazzjoni wara t- trattament, sintomi newroloġici li jgħaddu bħal għejja, tregħid ma´kullimkien, sinjali fl- għajnejn (twessiegħ fit- toqba tal- mamma tal- għajn, ftit akkomodazzjoni ta´l - għajn, oxxillazzjoni kontinwa waħda ġo l- oħra tal- boċċi tal- għajnejn), respirazzjoni li mhix normali, tbeżżieq u rriġettar jistgħu jsiru, kultant.
This is not a sign of intoxication and disappears within some minutes without treatment.
Dan m´huwiex sinjal t’ intossikazzjoni, u tisparixxi fi ftit minuti mingħajr xi trattament.
Correct application will minimise licking of the application site.
Jekk il- prodott jiġi applikat tajjeb, inqas jilgħaq l- annimal il- post t´applikazzjoni.
In case of accidental oral uptake, symptomatic treatment should be performed by a veterinary surgeon.
F´każ li l- prodott jittieħed aċċidentalment orali, trattament simptomatiċi għandu jiġi meħud. minn tabib veterinarju.
There is no known specific antidote.
M´hemm l- ebda antidot speċifiku magħruf.
The use of activated charcoal may be beneficial.
L- użu ta´ karbonju attivat jista´jkun ta´benefiċċju.
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.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
DOŻA GĦAL KULL SPEĊJE, MOD( I) U METODU TA 'AMMINISTRAZZJONI
For external use only.
Għall- użu estern biss.
To prevent licking, apply topically to the skin restricting the area of application to the cat’ s neck at the base of the skull.
Biex tevita li l- annimal jilgħaq l- mediċina, applika topikali fuq il- ġilda u llimita l- applikazzjoni fuq l - għonq tal- qattus, fuq in- naħa ta´wara tal- kranju.
Dosage schedule
Skeda tad- doża
The recommended minimum doses are 10 mg/ kg bodyweight imidacloprid and 1.0 mg/ kg bodyweight moxidectin, equivalent to 0.1 ml/ kg bodyweight Advocate for cats.
Id- dożi minimi rrikkmandati huma ta´10mg Imidakloprid għal kull kg użin tal- ġisem. u 1. 0 mg Moksidektin għal kull kg użin tal- ġisem, li jiġu ekwivalenti għal 0. 1ml Advocate għall- qtates, għal kull kg użin tal- ġisem.
The treatment schedule should be based on the local epidemiological situation.
L- iskeda ta´ trattament għandha tiġi bbażata fuq il- sitwazzjoni epidemjoloġika lokali.
Weight of cat [kg]
Użin tal -
Volume Imidacloprid [ml] [mg/ kg bw]
[mg/ kg użin tal - ġisem]
Moxidectin [mg/ kg bw]
[mg/ kg użin tal - ġisem]
minimum of 10
Minimu ta´ 10
minimum of 1
Minimu ta´1
appropriate combination of pipettes
Il- kombinazzjoni adattata tal- pipetti
53 Flea treatment and prevention
Trattament u prevenjoni tal- briegħed
One treatment prevents further flea infestation for 4 weeks.
Trattament wieħed jippreveni t- tixrid ta´ briegħed għall - 4 ġimgħat.
Pre-existing pupae in the environment may continue to emerge for 6 weeks or longer after treatment is initiated depending upon climatic conditions.
Pupa li tkun qiegħda fl- inħawi tista´titfaċċa wara 6 ġimgħat jew aktar wara li l- kura tiġi mibdija, jiddependi fuq il- kundizzjonijiet tal - klima.