qanastek/EMEA-V3 huggingface dataset:
Special precautions for use in animals
19 Prekawzjonijiet speċjali għall- użu fl- annimali
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Jekk tiġi injettat bi żball b' dan il- prodott, fittex għajnuna medika, anke jekk ammont żgħir ħafna jkun ġie injettat u ħu miegħek il- fuljett ta 'tagħrif li jinsab fil- pakkett.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
Jekk l- uġigħ idum għal aktar minn tnax- il siegħa, wara l- eżami mediku, erġa 'fittex parir mediku.
Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Anke jekk ġew injettati ammonti żgħar, injezzjoni bi żball ta ’ dan il - prodott tista 'tikkawż nefħa intensa, li tista' per eżempju tikkawża nekrożi iskimika u anke l- bżonn li jinqata 'xi subgħa.
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Attenzjoni minn kirurgu espert għandha tingħata mal- ewwel u jista ’ jkun hemm bżonn li jinfetaħ is- subgħa u tiġi rrigata l- parti fejn seħħet l- injezzjoni, speċjalment fejn hemm involut il- laħam tas- subgħa u t- tendin tal- muskolu.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Ebda informazzjoni dwar is- sigurtà u l- effikaċja ta ’ dan il- vaċċin ma hija disponibbli meta użat ma ’ prodott mediċinali veterinarju ieħor.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Għalhekk, deċiżjoni biex dan il- vaċċin jintuża qabel jew wara kwalunkwe prodott mediċinali veterinarju ieħor teħtieġ issir fuq bażi ta ’ każ b’ każ.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS
PREKAWZJONIJIET SPEĊJALI DWAR RIMI TA 'PRODOTT MHUX UŻATA JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
- Cardboard box with 1 and 10 vials of 25 doses.
- Kaxxa tal- kartun b’ kunjett 1 u b’ 10 kunjetti ta ’ 25 doża.
EPAR summary for the public This document is a summary of the European Public Assessment Report.
Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropea.
What is STRONGHOLD?
X’ inhu STRONGHOLD?
STRONGHOLD is a spot-on solution that contains the active substance selamectin, which belongs to a class of medicines having an antiparasitic action.
STRONGHOLD hu soluzzjoni spot- on li jkun fiha s- sustanza attiva selamectin, li tagħmel parti mill- klassi ta ’ mediċini li jkollhom azzjoni antiparassitika.
Stronghold is available in 2 different concentrations (6% and 12%) and in tubes of various strengths (15, 30, 45, 60, 120 and 240 mg). The concentration and the strength to use, depends on the weight and species of the animal being treated.
Il- konċentrazzjoni u d- doża li għandha tintuża tiddependi mill- piż u l- ispeċi ta ’ annimali li jkunu qed jiġu ttratati.
What is STRONGHOLD used for?
Għalxiex jintuża STRONGHOLD?
STRONGHOLD is used to treat and prevent infestations with parasites that live on the skin or in the fur of cats and dogs, such as fleas and mites, as well as treating worm parasites that live inside the body.
STRONGHOLD jintuża fit- trattament u l- prevenzjoni ta ’ infestazzjonijiet b’ parassiti li jgħixu fuq il- ġilda u fuq is- suf tal- klieb u l- qtates, bħall- briegħed, kif ukoll għat- trattament ta ’ parassiti dud li jgħixu fil- ġisem.
It is used in the following ways:
Jintuża b’ dawn il- modi:
to treat and prevent flea infestations in cats and dogs, by killing adult fleas, their larvae and their eggs on the animal, and in the litters of pregnant or nursing cats or dogs.
biex jittratta u jipprevjeni infestazzjonijiet mill- briegħed fil- klieb u l- qtates, bil- qtil ta ’ briegħed adulti, il- larva tagħhom u l- bajd tagħhom fuq l- annimal, u fil- frieħ ta ’ qtates u klieb li jkunu qed ireddgħu.
It can also be used as part of treatment for flea allergy dermatitis (skin inflammation) and to help control existing flea infestations, by killing eggs and larvae in the areas to which the animal has access, so breaking the flea life-cycle.
Jista ’ jintuża wkoll bħala parti mit- trattament għad- dermatite allerġika tal- briegħed (infjammazzjoni fil- ġilda) u biex jgħin fil- kontroll ta ’ infestazzjonijiet eżistenti mill- briegħed, bil- qtil tal- bajd u l- larva f’ żoni li jkollu aċċess għalihom l- annimal, u b’ hekk jiksru ċ- ċiklu tal- ħajja tal- bergħud.
to prevent heartworm disease in cats and dogs, to treat ear mites in cats and dogs, to treat adult intestinal roundworms and intestinal hookworms in cats, to treat adult intestinal roundworms in dogs to treat biting lice in dogs and cats, to treat sarcoptic mange (scabies) in dogs,
biex jipprevjenu l- heartworm disease fil- qtates u fil- klieb, biex jittrata l- parassiti fil- widnejn tal- klieb u l- qtates, biex jittratta r- roundworms u l- hookworms intestinali fil- qtates, biex jittratta r- roundworms intestinali adulti fil- klieb biex jittratta l- qamel fil- klieb u l- qtates, biex jittratta l- mard tal- ġilda fil- klieb,
contents of the tube are squeezed onto the skin after parting the fur between the shoulder
Il- kontenut tat- tubu jiġi applikat fuq il- ġilda wara li jinferaq is- suf ta ’ bejn il- ġwienaħ ta ’ l - ispallejn.
This small volume of liquid is absorbed through the skin and has an effect throughout the animal’s body.
Dan il- volum żgħir ta ’ likwidu jiġi assorbit minn ġilda u jkollu effett fil- ġisem kollu ta ’ l- annimal.
The strength used and the number of administrations depend on the weight and species of the animal being treated, and the type of parasite.
Id- doża użata u n- numru ta ’ ammministrazzjonijiet tiddependi mit- toqol u l - ispeċi ta ’ l- annimal ittrattat, u t- tip ta ’ parassit.
See the Package Leaflet for further information.
Ara l- Fuljett ta ’ Tagħrif għal iktar tagħrif.
Reproduction is authorised provided the source is acknowledged How does STRONGHOLD work?
Reproduction is authorised provided the source is acknowledged Kif jaħdem STRONGHOLD?
STRONGHOLD contains selamectin, which is an antiparasitic medicine that belongs to the ‘avermectin’ class.
STRONGHOLD ikun fih selamectin, li hu mediċina antiparassitika li tagħmel parti mill- klassi magħrufa bħala ‘ avermectin ’.
Selamectin activates special proteins called ‘chloride channels’ on the surface of nerve and muscle cells, disrupting their normal electrical activity.
Selamectin jattiva proteini speċjali magħrufa bħala ‘ kanali tal - klorur ’ fuq is- superfiċje taċ- ċelloli tan- nervituri u tal- muskoli, u b’ hekk iħarbtu l- attività elettrika normali.
This causes the paralysis or death of the parasites.
Dan jikkawża l- paraliżi jew il- mewt tal- parassiti.
How has STRONGHOLD been studied?
Kif ġie studjat STRONGHOLD?
STRONGHOLD has been studied in the treatment of a wide range of breeds of dog and cat for the parasitic infestations listed above.
STRONGHOLD ġie studjat fit- trattament ta ’ varjetà wiesgħa ta ’ razez tal- klieb u l- qtates għall- infestazzjonijiet parassitiċi msemmija hawn fuq.
What benefit has STRONGHOLD shown during the studies?
X’ benefiċċju wera STRONGHOLD f’ dawn l- istudji?
STRONGHOLD treatment was found to be effective after a single administration or repeated treatments at monthly intervals, depending on the type of infestation it was being used to treat or prevent.
Instab li jekk it- trattament bi STRONGHOLD ikunx iktar effettiv wara amministrazzjoni waħdanija jew bi trattament ripetut kull xahar jiddependi mit- tip ta ’ infestazzjoni li kien qed jittratta.
In field studies, it reduced the flea comb counts by up to 98% in cats and 99% in dogs 90 days after treatment, as well as preventing flea eggs from hatching, and killing and preventing the development of flea larvae.
Fl- istudji fl- ambjent naturali, naqqas l- għadd ta ’ briegħed b’ sa 98% fil- qtates u 99% fil- klieb wara t- trattament, kif ukoll fil- prevenzjoni tat- tfaqqis tal- bajd u fil- prevenzjoni ta ’ l- iżvilupp tal- larva tal- briegħed.
Field studies also showed that STRONGHOLD was 100% effective in preventing heart worm disease in dogs and cats.
L- istudji fl- ambjent naturali wrew li STRONGHOLD kien 100% effettiv fil- prevenzjoni tal- heart worm disease fil- klieb u l- qtates.
It is also effective in treating ear mites in cats and dogs.
Kien effettiv ukoll fit - trattament ta ’ parassiti tal- widna fil- klieb u l- qtates.
In the treatment of sarcoptic mange in dogs, two treatments given 30 days apart were required to completely eliminate the mites in dogs.
Fit- trattament tal- mard tal- ġilda fil- klieb, kien hemm bżonn żewġ trattamenti bi 30 jum bejniethom biex jeliminaw kompletament il - parassiti fil- klieb.
STRONGHOLD was also effective in the treatment of adult intestinal hookworms in cats, adult intestinal roundworms in cats and dogs, and biting lice in dogs and cats.
STRONGHOLD kien effettiv ukoll fit- trattament ta ’ hookworms intestinali adulti fil- qtates, roundworms intestinali adulti fil- qtates u l- klieb, u qamel li jigdmu fil- klieb u l- qtates.
Shampooing or soaking the animal two hours or more after treatment did not affect the medicine’s effectiveness.
Il- ħasil jew l- għorik ta ’ l- annimal għal sagħtejn jew iktar wara t- trattament m’ affettwax l - effikaċja tal- mediċina.
What is the risk associated with STRONGHOLD?
X’ inhu r- riskju assoċjat ma ’ STRONGHOLD?
In rare cases, STRONGHOLD causes temporary alopecia (hair loss) at the application site in cats.
F’ każijiet rari, STRONGHOLD jikkawża twaqqigħ ta ’ xagħar temporanju fis- siti fejn jiġi applikat fil- qtates.
Very rarely, there is also temporary irritation at the application site.
F’ każijiet rari ħafna, kien hemm ukoll irritazzjoni temporanja fis- sit ta ’ l - applikazzjoni.
On rare occasions, STRONGHOLD may produce clumping of the hair at the application site or the appearance of a small quantity of a white powder.
F’ okkażjonijiet rari, STRONGHOLD jista ’ jwassal biex is- suf fis- sit ta ’ l- applikazzjoni jagħqad f’ boċċi jew biex titfaċċa kwantità żgħira ta ’ trab abjad.
This does not affect the safety or effectiveness of the medicine.
Dan ma jaffettwax is- sigurtà u l- effIKAĊJA tal- mediċina.
STRONGHOLD must not be used in animals under six weeks of age.
STRONGHOLD m’ għandux jintuża f’ annimali ta ’ inqas minn sitt ġimgħat.
It must also not be used in cats that are suffering from another disease or that are debilitated and underweight for their size and age.
M’ għandux jintuża fil- qtates li jkunu qed ibatu minn marda oħra jew li jkunu dgħajfa jew li jkunu jiżnu inqas milli suppost skond l- età u d- daqs tagħhom.
The Package Leaflet should be read before use.
Qabel ma jintuża dan il- prodott għandu jinqara l- Fuljett ta ’ Tagħrif.
Do not smoke, eat or drink while handling STRONGHOLD.
Billi jaqbad malajr ħafna, STRONGHOLD għandu jinżamm ’ il bogħod mis- sħana, minn xrar, minn fjammi jew minn sorsi ta ’ tqabbid ta ’ nar.
If STRONGHOLD gets into the eyes, flush the eyes immediately with water and seek medical attention.
M’ għandekx tpejjep, tiekol jew tixrob waqt li tkun qed timmanipola STRONGHOLD.
Keep treated animals away from fires and other sources of ignition for at least 30 minutes or until the hair coat is dry.
Aħsel idejk wara li tużah u laħlaħ il- ġilda bl- ilma u s- sapun biex tneħħi xi fdalijiet tal- prodott.
People with sensitive skin or known allergy to products of this type should handle STRONGHOLD with caution.
Jekk STRONGHOLD jidħol fl- għajnejn, laħlaħ l- għajnejn immedjatament bl- ilma u kellem tabib.
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of STRONGHOLD exceed the risks for the treatment and prevention of parasitic infestations in cats and dogs.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) qabel li l- benefiċċji ta ’ STRONGHOLD huma ikbar mir- riskji tiegħu għat- trattament u l- prevenzjoni ta ’ infestazzjonijiet parassitiċi fil- qtates u l- klieb.
The Committee recommended that STRONGHOLD be given a marketing authorisation.
Il- Kumitat irrakkomanda li STRONGHOLD jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
The benefit-risk balance may be found in module 6 of this EPAR.
Il- bilanċ bejn ir- riskju u l- benefiċċju jinstab fil- modulu 6 ta ’ dan l- EPAR.
Other information about STRONGHOLD:
Tagħrif ieħor dwar STRONGHOLD:
The European Commission granted a marketing authorisation valid throughout the European Union for STRONGHOLD to Pfizer Ltd. on 25 November 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal STRONGHOLD lil Pfizer Ltd. fil- 25 ta ’ Novembru 1999.
The marketing authorisation was renewed on 25 November 2004.
L - awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fil- 25 ta ’ Novembru 2004.
Information on the prescription status of this product may be found on the label/outer package.
Informazzjoni dwar l- istejtus ta ’ preskrizzjoni ta ’ dan il- prodott tista ’ tinstab fuq it- tikketta/ pakkett ta ’ barra.
STRONGHOLD 15 mg spot-on solution
STRONGHOLD 15 mg soluzzjoni għal użu topikali
STRONGHOLD 30 mg spot-on solution
STRONGHOLD 30 mg soluzzjoni għal użu topikali
STRONGHOLD 45 mg spot-on solution
STRONGHOLD 45 mg soluzzjoni għal użu topikali
STRONGHOLD 60 mg spot-on solution
STRONGHOLD 60 mg soluzzjoni għal użu topikali
STRONGHOLD 120 mg spot-on solution
STRONGHOLD 120 mg soluzzjoni għal użu topikali
STRONGHOLD 240 mg spot-on solution
STRONGHOLD 240 mg soluzzjoni għal użu topikali
Each unit dose (tube) of STRONGHOLD delivers:
Kull doża waħda (tubu) ta ’ STRONGHOLD tagħti:
Active substance
Sustanza( i) Attiva( i)
6% w/ v solution
soluzzjoni 6% w/ v
12% w/ v solution 6% w/ v solution 12% w/ v solution 12% w/ v solution 12% w/ v solution
soluzzjoni 12% w/ v soluzzjoni 6% w/ v soluzzjoni 12% w/ v soluzzjoni 12% w/ v soluzzjoni 12% w/ v
Selamectin Selamectin Selamectin Selamectin Selamectin
Selamektin Selamektin Selamektin Selamektin Selamektin
Excipients
Ingredjenti Oħra
0.08% butylated hydroxytoluene
0. 08% butylated hydroxytoluene
Spot-on solution
Soluzzjoni għal użu topikali.
Dogs, cats
Klieb, qtates
Cats and dogs: treatment and prevention of flea infestations caused by Ctenocephalides spp. for one month following a single administration.
Qtates u klieb: kura u prevenzjoni minn infestazzjonijiet tal- briegħed ikkawżat mill- ispeċi Ctenocephalides sa xahar wara li tingħata doża waħda.
This is as a result of the adulticidal, larvicidal and ovicidal properties of the product.
Dan jiġri billi l- prodott joqtol kemm il - bergħud kif ukoll il- larva u l- bajd tiegħu.
The product is ovicidal for 3 weeks after administration.
Il- prodott joqtol il- bajd sa tliet ġimgħat wara li jingħata.
Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will also aid in the prevention of flea infestations in the litter up to seven weeks of age.
Bi tnaqqis fil- popolazzjoni tal- briegħed, trattament kull xahar ta ’ annimali tqal u li qed irreddgħu jgħin ukoll biex ihħares il- btan sa seba ’ ġimgħat minn infestazzjonijiet tal- briegħed.
The product can be used as part of a treatment strategy for flea allergy dermatitis and through its ovicidal and larvicidal action may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Il- prodott jista ’ jintuża bħala parti minn programm ta ’ kura tad- dermatite kkawżata minn allerġija għall- briegħed u billi joqtol il- bajd u l- larva jista ’ jgħin biex jikkontrolla infestazzjonijiet tal- briegħed fl- ambjent f’ dawk l- inħawi fejn jersaq l- annimal.
2 Cats and dogs: prevention of heartworm disease caused by Dirofilaria immitis with monthly administration.
2 Qtates u klieb: prevenzjoni mill- marda tal- heartworm ikkawżata mid- Dirofilaria immitis b’ amministrazzjoni kull xahar.
STRONGHOLD may be safely administered to animals infected with adult heartworms, however, it is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more living in countries where a vector exists should be tested for existing adult heartworm infections before beginning medication with STRONGHOLD.
STRONGHOLD jista ’ jintuża bla periklu fuq annimali infettati bil- forma adulta tal- heartworm, imma prattika tajba veterinarja titlob li l- annimali kollha ta ’ ‘ l fuq minn sitt xhur u li jgħixu f’ pajjiżi fejn jeżistu parassiti li jġorru il- marda, għandhom jiġu ttestjati għal infezzjoni bil- forma adulta tal - heartworm qabel ma tinbeda l- kura bi STRONGHOLD.
This product is not effective against adult D. immitis.
Dan il- prodott ma jaħdimx kontra l- forma adulta tad- D. immitis.
Cats and dogs: treatment of ear mites (O. cynotis).
Qtates u klieb: kura għad- dud tal- widnejn (O. cynotis).
Cats: treatment of adult roundworms (Toxocara cati) and adult intestinal hookworms (Ancylostoma tubaeforme).
Qtates: kura għall- forma adulta tal- ħniex it- tondi (Toxocara cati) u għall- forma adulta tal- hookworm fl- imsaren (Ancylostoma tubaeforme).
Cats: treatment of biting lice infestations (Felicola subrostratus)
Qtates: kura għal infestazzjonijiet ta ’ qamel li jigdem (Felicola subrostratus).
Dogs: treatment of biting lice infestations (Trichodectes canis)
Klieb: kura għal infestazzjonijiet ta ’ qamel li jigdem (Trichodectes canis).
Dogs: treatment of sarcoptic mange (caused by S. scabiei).
Klieb: kura għal sarcoptic mange (ikkawżata minn S. scabiei).
Dogs: treatment of adult intestinal roundworms (Toxocara canis)
Klieb: kura għall- forma adulta tal- ħniex todi (Toxocara canis) fl- imsaren.
Do not use in animals under 6 weeks of age.
Tużax fuq annimali ta ’ taħt is- sitt ġimgħat.
Do not use in cats that are suffering from concomitant disease, or are debilitated and underweight (for size and age).
Tużax fuq qtates li qed ibatu minn xi mard ieħor fl- istess żmien jew li jkunu debboli u ta ’ piż baxx (għad- daqs u l- eta ’ tagħhom).
Animals may be bathed 2 hours after treatment without loss of efficacy.
Annimali jistgħu jinħaslu sagħtejn wara il- kura mingħajr ma jkun hemm nuqqas fl- effett.
For ear mite treatment, do not apply directly to the ear canal.
Għall- kura tad- dud tal- widnejn, tapplikax direttament fil- kanal tal- widnejn.
It is important to apply the dose as indicated to minimise the quantity that the animal can lick off.
Huwa mportanti li tingħata d- doża kif indikat biex jitnaqqas l- ammont li l- annimal jista ’ jilgħaq.
If significant licking does occur, a brief period of hypersalivation may rarely be observed in cats.
Jekk l- annimal jilgħaq fit- tul, f’ każi rari jista ’ jkun hemm produzzjoni għolja ta ’ bżieq fil- qtates, għal perjodu qasir.
This product is to be applied to the skin surface only.
Dan il- prodott għandu jiġi applikat biss fuq il- wiċċ tal- ġilda.
Do not administer orally or parenterally.
Tagħtix mill- ħalq jew permezz ta ’ injezzjoni.
Do not apply when the animal’ s hair coat is wet.
Tapplikax meta l- pil ta ’ l- annimal ikun imxarrab.
However, shampooing or soaking the animal 2 or more hours after treatment will not reduce the efficacy of the product.
Iżda jekk taħsel b’ xampu jew tgħaddas l- annimal sagħtejn jew aktar wara l- kura, ma jnaqqasx l- effett.
Do not allow treated animals to bathe in water courses until at least two hours after treatment administration.
Tħallix annimali kkurati jidħlu f’ ilma ġieri ta ’ l- anqas sa sagħtejn minn meta tingħata l- kura.
Read package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel ma tuża.
This product is highly flammable; keep away from heat, sparks, open flame or other sources of ignition.
Dan il- prodott jieħu n- nar malajr - Żomm il- bogħod mis- sħana, xrar tan- nar, fjammi jew affarijiet oħra li jistgħu iqabbdu n- nar.
3 Do not smoke, eat or drink while handling the product.
3 Tpejjipx, tiekolx u tixrobx waqt li qed tmiss il- prodott.
Wash hands after use and wash off any product in contact with the skin immediately with soap and water.
Aħsel idejk wara li tuża u aħsel fil- pront bis- sapun u bl- ilma jekk xi ftit mill- prodott imiss mal- ġilda.
If accidental eye exposure occurs, flush the eyes immediately with water and seek medical attention.
F’ każ aċċidentali li fih jintlaqtu l- għajnejn, laħlaħ fil- pront b’ ilma nadif u fittex kura medika.
Keep treated animals away from fires and other sources of ignition for at least 30 minutes or until the hair coat is dry.
Żomm annimali kkurati l- bogħod minn nirien u affarijiet oħra li jistgħu iqabbdu n- nar għal mill- anqas tletin minuta jew sakemm il- pil ikun niexef.
Avoid direct contact with treated animals until the application area is dry.
Evita kuntatt dirett ma ’ annimali kkurati sakemm tinxef ir- roqgħa fejn ġie applikat.
Keep children away from treated animals for at least 30 minutes following application of the product or until the hair coat is dry.
Żomm it- tfal il - bogħod minn annimali kkurati għal mill- anqas tletin minuta wara l- applikazzjoni jew sakemm il- pil ikun niexef.
Use of the product in cats has on rare occasions been associated with a mild transient alopecia at the site of application.
L- użu tal- prodott fuq il- qtates ġie li kkaġuna, f’ każi rari, telf żgħir u li jgħaddi ta ’ pil fuq il- parti fejn ikun ġie applikat.
On very rare occasions transient focal irritation may also be observed.
F’ każi rari ħafna jista ’ jkun hemm irritazzjoni li tgħaddi fuq il- parti fejn ikun ġie applikat.
The alopecia and irritation are normally self-resolving, but symptomatic therapy may be applicable in some circumstances.
In- nuqqas ta ’ pil u irritazzjoni normalment jgħaddu waħedhom, imma f’ xi każi tista ’ tingħata xi kura biex ittaffi s- sintomi.
On rare occasions, application of the product may produce a local temporary clumping of the hair at the application site and/ or an occasional appearance of a small quantity of a white powder.
F’ każi rari l- applikazzjoni tista ’ twassal biex il- pil fil- post fejn ġie applikat jitgħaqqad temporanjament u/ jew f’ xi każi titfaċċa kwantita ’ żgħira ta ’ trab abjad.
This is normal and will disappear typically within 24 hours of treatment administration and does not affect either the safety or efficacy of the product.
Din hija ħaġa normali u titlaq fi żmien 24 siegħa minn meta jiġi applikat u ma taffettwax il- ħarsien tas- saħħa jew l- effett tal- prodott.
Exceptionally, as with other macrocyclic lactones, reversible neurological signs have been observed after use of the product.
Kif jiġri ma ’ macrocyclic lactones oħrajn, f’ każijiet eċċezzjonali, wara li jintuża l- prodott ġew osservati sinjali newroloġiċi li huma riversibbli.
STRONGHOLD can be used in breeding, pregnant and lactating cats and dogs.
STRONGHOLD jista ’ jintuża waqt it- tnissil, tqala jew fi żmien il- ħalib fil- qtates u fil- klieb.
In extensive field testing no interactions between STRONGHOLD and routinely used veterinary medicinal products or medical or surgical procedures were observed.
Fi studji estensivi waqt l- użu ma kienux osservati effetti bejn STRONGHOLD u prodotti mediċinali veterinarji komuni jew proċeduri mediċi u kirurġiċi.
For external use only.
Għal użu fuq barra biss.
Apply topically to the skin at the base of the neck in front of the shoulder blades.
Applika topikalment fuq il- ġilda fin- naħa t’ isfel ta ’ l- għonq quddiem l- għadmiet ta ’ l- ispalel.
STRONGHOLD should be administered as a single topical application of a unit dose delivering a minimum of 6 mg/ kg selamectin.
STRONGHOLD għandu jingħata f’ applikazzjoni topikali ta ’ doża waħda li tagħti mill- anqas 6 mg/ kg selamektin.
When concurrent infestations or infections in the same animal are to be treated with the product, only one topical application of the recommended 6 mg/ kg dose should be administered at any one time.
Meta jkunu qed jiġu ikkurati aktar minn infestazzjoni jew infezzjoni waħda fl- istess annimal, applikazzjoni topikali waħda biss ta ’ 6 mg/ kg hija rakkomandata f’ ħin wieħed.
The appropriate length of the treatment period for individual parasites is specified below.
It- tul xieraq tal- perjodu ta ’ kura għal kull parassita jidher hawn taħt.
4 Administer in accordance with the following table:
Agħti skond kif indikat fit- tabella li tmiss:
Cats (kg)
Qtates (kg) ≤2. 5 2. 6- 7. 5 > 7. 5
Tube cap colour
Kulur tat - tapp tat- tubu Roża Ikħal
15 45 Appropriate combination of tubes
mg ta ’ selamektin mogħtija 15 45 Taħlita xierqa ta ’ tubi
60 60 60
Qawwa (mg/ ml) 60 60 60
0.25 0.75 Appropriate combination of tubes
Volum amministrat (daqs nominali tat- tubu – ml) 0. 25 0. 75 Taħlita xierqa ta ’ tubi
Dogs (kg)
4 Klieb (kg)
Tube cap colour
Kulur tat - tapp tat- tubu
mg of selamectin dispensed
mg ta ’ selamektin mogħtija
Potency (mg/ ml)
Qawwa (mg/ ml)
Administered volume (nominal tube size- ml)
Volum amministrat (daqs nominali tat- tubu – ml)
Rose Violet Brown Red Green
Roża Vjola Kannella Aħmar Aħdar
15 30 60 120 240 Appropriate combination of tubes
15 30 60 120 240 Taħlita xierqa ta ’ tubi
0.25 0.25 0.5 1.0 2.0 Appropriate combination of tubes
0. 25 0. 25 0. 5 1. 0 2. 0 Taħlita xierqa ta ’ tubi
Flea treatment and prevention (cats and dogs)
Kura u prevenzjoni mill- briegħed (qtates u klieb)
Following administration of the product, the adult fleas on the animal are killed, no viable eggs are produced, and larvae (found only in the environment) are also killed.
Wara li jiġi applikat il- prodott, il- briegħad adulti fuq l- annimal jinqatlu u ma jkunx hemm aktar bajd vijabbli u l- larva (li jinsabu biss fl- ambjent) jinqatlu ukoll.
This stops flea reproduction, breaks the flea lifecycle and may aid in the control of existing environmental flea infestations in areas to which the animal has access.
B’ hekk il- bergħud ma jirriproduċiex, jinkiser iċ- ciklu tal- ħajja tal- bergħud u dan jista ’ jgħin biex jikkontrolla infestazzjonijiet tal- briegħed fl- ambjent f’ dawk l- inħawi fejn jersaq l- annimal..
For the prevention of flea infestations, the product should be administered at monthly intervals throughout the flea season, starting one month before fleas become active.
Għal prevenzjoni minn infestazzjonijiet tal- briegħed, il- prodott għandu jingħata kull xahar waqt l - istaġun tal- briegħed u xahar qabel ma l- briegħed isiru attivi.
Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will aid prevention of flea infestations in the litter up to seven weeks of age.
Billi l- popolazzjoni ta ’ briegħed titnaqqas, il- kura ta ’ kull xahar f’ annimali tqal jew li qed ireddgħu, tgħin biex tħares ‘ il boton minn infestazzjonijiet tal- briegħed sa l- eta ’ ta ’ seba ’ ġimgħat.
For use as part of a treatment strategy for flea allergy dermatitis the product should be administered at monthly intervals.
Għal użu bħala parti minn programm ta ’ kura tad- dermatite kkawżata minn allerġija għall- briegħed, il - prodott għandu jiġi applikat kull xahar.
Prevention of heartworm disease (cats and dogs)
Prevenzjoni mill- mard tal- heartworm (qtates u klieb)
The product may be administered year-round or at least within one month of the animal’ s first exposure to mosquitoes and monthly thereafter until the end of the mosquito season.
Il- prodott jista ’ jingħata s- sena kollha jew ta ’ l- anqas fi żmien xahar minn meta l- annimal ġie espost għan- nemus għall- ewwel darba, u kull xahar wara sakemm jagħlaq l- istaġun tan- nemus.
The final dose must be given within one month after the last exposure to mosquitoes.
L- aħħar doża għandha tingħata sa xahar wara li l- annimal l- aħħar ġie espost għan- nemus.
If a dose is missed and a monthly interval between dosing is exceeded then immediate administration of the product and resumption of monthly dosing will minimise the opportunity for the development of adult heartworms.
Jekk tinqabeż xi doża jew l- intervall bejn doża u oħra ikun ta ’ aktar minn xahar, għandha tingħata doża immedjata u terġa ’ tibda tingħata mill- ġdid, doża fix- xahar u b’ hekk titnaqqas l- opportunita ’ biex jiżviluppaw heartworms adulti.
When replacing another heartworm preventive product in a heartworm disease prevention programme, the first dose of the product must be given within a month of the last dose of the former medication.
Meta jkun qed jiġi mibdul prodott għall- prevenzjoni tal- heartworm fi programm ta ’ prevenzjoni mill- mard tal- heartworm, l- ewwel doża tal- prodott għanda tingħata fi żmien xahar mill - aħħar doża tal- mediċina ta ’ qabel.
Treatment of roundworm infections (cats and dogs)
Kura għal infezzjonijiet tal- ħniex tondi (qtates u klieb)
A single dose of the product should be administered.
Għanda tingħata doża waħda tal- prodott.
Treatment of biting lice (cats and dogs)
Kura għall- qamel li jigdem (qtates u klieb)
Treatment of ear mites (cats)
Kura għad- dud tal- widnejn (qtates)
5 Treatment of ear mites (dogs)
Kura għad- dud tal- widnejn (klieb)
A single dose of the product should be administered.
Għanda tingħata doża waħda tal- prodott għal xahrejn fuq xulxin.
A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Frak mhux imwaħħal għandu jitneħħa bil- mod mill- kanal ta ’ barra tal- widna waqt kull trattament.
Treatment of hookworm infections (cats)
Kura għal infezzjonijiet tal- hookworm (qtates)
Treatment of sarcoptic mange (dogs)
5/ 45 Kura għal sarcoptic mange (klieb)
For complete elimination of the mites, a single dose of the product should be administered for two consecutive months.
Biex jitneħħa d- dud kollu, għanda tingħata doża waħda tal- prodott għal xahrejn fuq xulxin.
Remove the STRONGHOLD tube from its protective package
Neħħi t- tubu ta ’ STRONGHOLD mill- pakkett protettiv.
Holding the tube upright, firmly depress the cap to puncture the applicator seal, then remove the cap
Filwaqt li żżomm it- tubu wieqaf, agħfas it- tapp bis- saħħa biex ittaqqab is - siġil ta ’ l- applikatur, imbgħad neħħi t- tapp.
Part the hair at the base of your animal’ s neck in front of the shoulder blades to expose a small area of skin
Ofroq il- pil fin- naħa t’ isfel ta ’ l- għonq ta ’ l- annimal tiegħek quddiem l - għadmiet ta ’ l- ispalel biex tikxef roqgħa żgħira tal- ġilda.
Apply the tip of the STRONGHOLD tube directly to the skin without massaging.
Applika l- ponta tat- tubu ta ’ STRONGHOLD direttament fuq il- ġilda mingħajr ma timmassaġġja.
Squeeze the tube firmly to empty the contents in one spot.
Agħfas it- tubu b’ saħħtek biex tiżvojta l- kontenut f’ roqgħa waħda.
Avoid contact between the product and your fingers.
Evita li tmiss il- prodott b’ subgħajk.
STRONGHOLD was administered at 10 times the recommended dose, and no undesirable effects were observed.
STRONGHOLD ingħata f’ doża li kienet għaxar darbiet aktar minn dik irrakkomandata, u ma dehrux effetti mhux mixtieqa.
The product was administered at 3 times the recommended dose to cats and dogs infected with adult heartworms and no undesirable effects were observed.
Il- prodott ingħata f’ doża tlett darbiet aktar minn dik rakkomandata fi qtates u klieb li kellhom heartworms adulti u ma dehrux effetti mhux mixtieqa.
The product was also administered at 3 times the recommended dose to breeding male and female cats and dogs, including pregnant and lactating females nursing their litters and at 5 times the recommended dose to ivermectin-sensitive collies, and no undesirable effects were observed.
Il- prodott ingħata wkoll f’ doża tlett darbiet aktar minn dik rakkomandata fi qtates u klieb irġiel u nisa waqt it- tnissil kif ukoll f’ nisa tqal u waqt li qed ireddgħu il- btan tagħhom, u f’ doża ħames darbiet aktar minn dik irrakkomandata fi klieb tar- razza collie sensittivi għall- ivermektin u ma dehrux effetti mhux mixtieqa.
6 4.11 Withdrawal period(s)
4. 11 Perjodu ta 'Tiżmim
PHARMACOLOGICAL PROPERTIES
KWALITAJIET < FARMAKOLOĠIĊI > < IMMUNOLOĠIĊI >
Pharmacotherapeutic group: therapeutic antiparasitic agent, ATCvet code:
Grupp farmakoterapewtiku: sustanza terapewtika kontra l- parassiti
QP54A A05 selamectin
QP54A A05 selamektin
5.1 Pharmacodynamic properties
6 5. 1 Kwalitajiet Farmakodinamiċi
Selamectin is a semi-synthetic compound of the avermectin class.
Selamektin hija sustanza semi- sintetika tal- klassi ta ’ l- avermektin.
Selamectin paralyses and/ or kills a wide range of invertebrate parasites through interference with their chloride channel conductance causing disruption of normal neurotransmission.
Selamektin tipparaliżża u/ jew toqtol firxa wiesgħa ta ’ parassiti invertebrati billi tfixkel il- kunduttivita ’ tal- kanali tal- kloru u b’ hekk tikkawża tħarbit fin- newrotrasmissjoni normali.
This inhibits the electrical activity of nerve cells in nematodes and muscle cells in arthropods leading to their paralysis and/ or death.
Dan ma jħallix li ssir attivita ’ elettrika fiċ- ċelluli tas - sistema nervuża tan- nematodi u taċ- ċelluli tal- muskoli fl- artropodi u b’ hekk iwassal għal paraliżi u/ jew il- mewt tagħhom.
Selamectin has adulticidal, ovicidal and larvicidal activity against fleas.
Selamektin joqtol il- forma adulta, il- bajd u l- larvi tal- briegħed.
Therefore, it effectively breaks the flea life cycle by killing adults (on the animal), preventing the hatching of eggs (on the animal and in its environment) and by killing larvae (environment only).
B’ hekk, b’ mod effettiv tkisser iċ- ċiklu tal- ħajja tal- bergħud billi toqtol l- adulti (fuq l- annimal), ma tħalliex il- bajd ifaqqas (fuq l- annimal u fl - ambjent) u toqtol il- larvi (fl- ambjent biss).
Debris from selamectin- treated pets kills flea eggs and larvae not previously exposed to selamectin and thus may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Frak minn annimali ttrattati bis- selamektin joqtol il- bajd tal- briegħed u l- larvi li ma kienux esposti qabel għas- selamektin u b’ hekk jista ’ jgħin biex jikkontrolla infestazzjonijiet tal- briegħed fl- ambjent f’ dawk l- inħawi fejn jersaq l- annimal.
Activity has also been demonstrated againstheartworm larvae.
Instab ukoll li jkun hemm effett kontra l - larvi tal- heartworm.
Following topical administration selamectin is absorbed from the skin reaching maximum plasma concentrations approximately 1 and 3 days after administration in cats and dogs respectively.
Wara li tingħata b’ mod topikali, selamektin tiġi assorbita mil- ġilda u tilħaq l- ogħla livelli fid- demm, bejn wieħed u ieħor ġurnata wara li tkun ingħatat lill- qtates u tlett- ijiem wara li tkun ingħatat lill- klieb.
Following absorption from the skin selamectin distributes systemically and is slowly eliminated from plasma as manifested in detectable plasma concentrations in dogs and cats 30 days after administration of a single topical dose at 6 mg/ kg.
Wara li tiġi assorbita mil- ġilda, selamektin tinfirex fis- sistema u tiġi eliminata mid- demm bil- mod, tant li konċentrazzjonijiet li jistgħu jitkejjlu, jinstabu fid- demm tal- klieb u tal- qtates sa 30 ġurnata wara li tkun ingħatat doża topikali ta ’ 6 mg għal kull kg piż.
The prolonged persistence and slow elimination of selamectin from plasma is reflected in the terminal elimination half-life values of 8 and 11 days in cats and dogs respectively.
Il- persistenza fit- tul tas- selamektin u l - eliminazzjoni mid- demm bil- mod huma riflessi f’ valuri tat- terminal elimination half- life ta ’ tmien t - ijiem fil- qtates u ħdax- il jum fil- klieb.
The systemic persistence of selamectin in plasma and the lack of extensive metabolism provide effective concentrations of selamectin for the duration of the inter-dosing interval (30 days).
Il- persistenza sistemika tas- selamektin fid- demm u n- nuqqas ta ’ metaboliżmu estensiv iwasslu għal saħħa effettiva biżżejjed fil- perjodu ta ’ bejn doża u oħra (30 ġurnata).
Selamectin may adversely affect fish or certain water-borne organisms on which they feed.
Selamektin jista ’ jkollha effett ħażin fuq il- ħut jew fuq ċerti ħlejjaq ta ’ l- ilma li jservu bħala ikel għall - ħut.
Containers and residual contents should be disposed of along with collected domestic refuse to avoid contamination of any water courses.
Il- kontenituri u materjal żejjed għandhom jintefgħu ma ’ l- iskart domestiku biex ma ssirx kontaminazzjoni minn fejn jista ’ jgħaddi ilma ġieri.
0.08% butylated hydroxytoluene.
0. 08% butylated hydroxytoluene
3 years.
Tlett snin.
Store in the unopened foil package in a dry place.
Aħżen fil- pakkett tal- folja, mhux miftuħ f’ post xott.
6.5 Nature and composition of immediate packaging
7 6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
STRONGHOLD is available in packs of three tubes (all tube sizes), six tubes (all tube sizes except 15 mg selamectin), or fifteen tubes (15 mg selamectin tube size only).
STRONGHOLD jiġi f’ pakketti ta ’ tlett tubi (tubi tad- daqsijiet kollha), ta ’ sitt tubi (tubi tad- daqsijiet kollha ħlief 15 mg selamektin), jew ta ’ ħmistax- il tubu (tubi ta ’ 15 mg selamektin biss).
Not all pack sizes may be marketed.
Jista ’ jkun li mhux id- daqs tal- pakketti kollha jistgħu qegħdin fis- suq.
The product will be in translucent polypropylene unit dose tubes in an aluminium and aluminium/ PVC blister overwrap.
Il- prodott ikun f’ tubi trasparenti tal- polypropilin, ta ’ doża waħda, f’ folja b’ kisja ta ’ aluminju u aluminju/ PVC.
The tubes are colour coded as follows:
It- tubi għandhom it- tapp ikkulurit hekk kif ġej:
Tubes with rose caps contain 0.25ml of 6% w/ v solution and deliver 15 mg of selamectin Tubes with blue caps contain 0.75 ml of 6% w/ v solution and deliver 45 mg of selamectin Tubes with violet caps contain 0.25 ml of 12% w/ v solution and deliver 30 mg of selamectin Tubes with brown caps contain 0.5 ml of 12% w/ v solution and deliver 60 mg of selamectin Tubes with red caps contain 1.0 ml of 12% w/ v solution and deliver 120 mg of selamectin Tubes with green caps contain 2.0 ml of 12% w/ v solution and deliver 240 mg of selamectin
Tubi b’ tappijiet roża fihom 0. 25ml ta ’ soluzzjoni 6% w/ v u jagħtu 15 mg selamektin Tubi b’ tappijiet koħol fihom 0. 75ml ta ’ soluzzjoni 6% w/ v u jagħtu 45 mg selamektin Tubi b’ tappijiet vjola fihom 0. 25ml ta ’ soluzzjoni 12% w/ v u jagħtu 30 mg selamektin Tubi b’ tappijiet kannella fihom 0. 5ml ta ’ soluzzjoni 12% w/ v u jagħtu 60 mg selamektin Tubi b’ tappijiet ħomor fihom 1. 0ml ta ’ soluzzjoni 12% w/ v u jagħtu 120 mg selamektin Tubi b’ tappijiet ħodor fihom 2. 0ml ta ’ soluzzjoni 12% w/ v u jagħtu 240 mg selamektin
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Prodott li ma ntużax jew materjal ħażin żejjed għandhom jintremew skond kif jitolbu ħtiġijiet lokali.
Sandwich Kent, CT13 9NJ United Kingdom
Pfizer Ltd Sandwich Kent CT13 9NJ United Kingdom
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA’ L- EWWEL AWTORIZZAZZJONI / TIĠDID TAL- AWTORIZZAZZJONI
25/ 11/ 1999 Renewal:
25/ 11/ 1999 Tiġdid:
10 DATE OF REVISION OF THE TEXT
DATA TA’ META ĠIET RIVEDUTA DIN IL- KITBA
8 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 tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // emea. europa. eu
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA( I) BIOLOĠIKA ATTIVA U SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL - KUMMERĊ INKLUŻI RESTRIZZJONIJIET FUQ IL - FORNIMENT U L- UŻU
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIOLOĠIKA( ĊI) ATTIVA( I) U SID (/ S- SIDIEN TA ’) L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
Pfizer Service Company bvba Hoge Wei, 10 B-1930 Zaventem Belgium
Pfizer Service Company bvba Hoge Wei, 10 B- 1930 Zaventem Belġju
LABELLING
12 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON LABEL, 15 mg (ALL PACK SIZES)
TIKKETTA TAL- KAXXA, 15 mg (DAQSIJIET KOLLHA)
Spot-on solution.
Soluzzjoni għal użu topikali.
Three tubes each containing 0.25 ml (15 mg selamectin).
Tliet tubi li fihom 0. 25 ml (15 mg selamektin) kull wieħed.
Fifteen tubes each containing 0.25 ml (15 mg selamectin).
Ħmistax- il tubu li fihom 0. 25 ml (15 mg selamektin) kull wieħed.
Cats and dogs weighing 2.5 kg or less
Qtates u klieb li jiżnu 2. 5 kg jew anqas
Spot-on solution for internal and external parasites
Soluzzjoni għal użu topikali għal parassiti interni u esterni
Cats and dogs:
Qtates u klieb:
Treatment and prevention of flea infestations (Ctenocephalides spp.); kills adult fleas, eggs and larvae; use as part of a treatment strategy for flea allergy dermatitis; may aid in the control of existing environmental flea infestations in areas to which the animal has access; treatment of adult roundworms (Toxocara spp.); prevention of heartworm disease (Dirofilaria immitis); treatment of biting lice (Felicola subrostratus (cats) and Trichodectes canis (dogs)); treatment of ear mites (Otodectes cynotis).
Kura u prevenzjoni minn infestazzjonijiet tal- briegħed (Ctenocephalides spp.); joqtol briegħed adulti, bajd u larvi; uża bħala parti minn programm ta ’ kura tad- dermatite kkawżata minn allerġija għall - briegħed; jista ’ jgħin biex jikkontrolla infestazzjonijiet tal- briegħed fl- ambjent f’ dawk l- inħawi fejn jersaq l- annimal; kura għall- forma adulta tal- ħniex tondi tal- imsaren (Toxocara spp.); prevenzjoni mill- marda tal- heartworm (Dirofilaria immitis); kura għal qamel li jigdem (Felicola subrostratus (cats) and Trichodectes canis (dogs)); kura għad- dud tal- widnejn (Otodectes cynotis).
Dogs:
Qtates: kura għall- forma adulta tal- hookworm fl- imsaren (Ancylostoma tubaeforme).
Treatment of sarcoptic mange (Sarcoptes scabiei);
Klieb: kura għal sarcoptic mange (Sarcoptes scabiei).
See package leaflet for complete indications and directions for use.
Ara l- fuljett tal- pakkett għal informazzjoni sħiħa fuq indikazzjonijiet u kif għandek tuża.
See package leaflet for complete warnings.
Ara l- fuljett tal- pakkett għal twissijiet sħaħ.
For ear mite treatment do not apply directly to the ear canal.
Għall- kura tad- dud tal- widnejn, tapplikax direttament fil- kanal tal- widnejn.
Highly Flammable; keep away from heat, sparks, open flame or other sources of ignition.
Jieħu n- nar malajr: żomm il- bogħod mis- sħana, xrar tan- nar, fjammi jew affarijiet oħra li jistgħu iqabbdu n- nar.
Keep children away from treated animals for at least 30 minutes following application of the product or until the hair coat is dry.
Żomm it- tfal il- bogħod minn annimali kkurati għal mill- anqas tletin minuta wara l- aplikazzjoni jew sakemm il- pil ikun niexef.
Do not smoke, eat or drink while handling the product.
Tpejjipx, tiekolx u tixrobx waqt li qed tmiss il- prodott.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Prodott li ma ntużax jew materjal żejjed għandhom jintremew skond kif jitolbu ħtiġijiet lokali.
For animal treatment only - to be supplied only on veterinary prescription.
Għat- trattament ta ’ l- annimali biss
Pfizer Ltd Sandwich Kent CT13 9NJ United Kingdom
Pfizer Ltd Sandwich Kent CT13 9NJ Renju Unit
EU/ 2/ 99/ 014/ 001 (3 tubes) EU/ 2/ 99/ 014/ 012 (15 tubes)
EU/ 2/ 99/ 014/ 001 (3 tubi) EU/ 2/ 99/ 014/ 012 (15- il tubu)
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
15 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA’ BARRA
CARTON LABEL, 30 mg (ALL PACK SIZES)
TIKKETTA TAL- KAXXA, 30 mg (DAQSIJIET KOLLHA)
Selamectin 30 mg
Selamektin 30 mg
Three tubes each containing 0.25 ml (30 mg selamectin).
Tliet tubi li fihom 0. 25 ml (30 mg selamektin) kull wieħed.
Six tubes each containing 0.25 ml (30 mg selamectin).
Sitt tubi li fihom 0. 25 ml (30 mg selamektin) kull wieħed.
Dogs weighing 2.6 – 5.0 kg.
Klieb li jiżnu bejn 2. 6 kg u 5 kg.
Treatment and prevention of flea infestations (Ctenocephalides spp.); kills adult fleas, eggs and larvae; use as part of a treatment strategy for flea allergy dermatitis; may aid in the control of existing environmental flea infestations in areas to which the animal has access; treatment of adult roundworms (Toxocara canis); prevention of heartworm disease (Dirofilaria immitis); treatment of sarcoptic mange (Sarcoptes scabiei); treatment of biting lice (Trichodectes canis); treatment of ear mites (Otodectes cynotis).
Kura u prevenzjoni minn infestazzjonijiet tal- briegħed (Ctenocephalides spp.); joqtol briegħed adulti, bajd u larvi; uża bħala parti minn programm ta ’ kura tad- dermatite kkawżata minn allerġija għall - briegħed; jista ’ jgħin biex jikkontrolla infestazzjonijiet tal- briegħed fl- ambjent f’ dawk l- inħawi fejn jersaq l- annimal; kura għall- forma adulta tal- ħniex tondi tal- imsaren (Toxocara canis); prevenzjoni mill- marda tal- heartworm (Dirofilaria immitis); kura għal sarcoptic mange (Sarcoptes scabiei); kura għal qamel li jigdem (Trichodectes canis); kura għad- dud tal- widnejn (Otodectes cynotis).
Do not use in animals under 6 weeks of age.
Tużax fuq qtates li qed ibatu minn xi mard ieħor fl- istess żmien jew li jkunu debboli u ta ’ piż baxx (għad- daqs u l- eta ’ tagħhom).
Highly Flammable; keep away from heat, sparks, open flame or other sources of ignition.
Jieħu n- nar malajr - Żomm il- bogħod mis- sħana, xrar tan- nar, fjammi jew affarijiet oħra li jistgħu iqabbdu n- nar.
EU/ 2/ 99/ 014/ 003 (3 tubes) EU/ 2/ 99/ 014/ 007 (6 tubes)
EU/ 2/ 99/ 014/ 003 (3 tubi) EU/ 2/ 99/ 014/ 007 (6 tubi)
19 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
18 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON LABEL, 45 mg (ALL PACK SIZES)
TIKKETTA TAL- KAXXA, 45 mg (DAQSIJIET KOLLHA)
Selamectin 45 mg
Selamektin 45 mg
Three tubes each containing 0.75 ml (45 mg selamectin).
Tliet tubi li fihom 0. 75 ml (45 mg selamektin) kull wieħed.
Six tubes each containing 0.75 ml (45 mg selamectin).
Sitt tubi li fihom 0. 75 ml (45 mg selamektin) kull wieħed.
Cats weighing 2.6 – 7.5 kg.
Qtates u klieb li jiżnu bejn 2. 6 kg u 7. 5 kg.
Treatment and prevention of flea infestations (Ctenocephalides spp.); kills adult fleas, eggs and larvae; use as part of a treatment strategy for flea allergy dermatitis; may aid in the control of existing environmental flea infestations in areas to which the animal has access; treatment of adult roundworms (Toxocara cati); prevention of heartworm disease (Dirofilaria immitis); treatment of ear mites (Otodectes cynotis); treatment of biting lice (Felicola subrostratus); treatment of adult intestinal hookworms (Ancylostoma tubaeforme).
Kura u prevenzjoni minn infestazzjonijiet tal- briegħed (Ctenocephalides spp.); joqtol briegħed adulti, bajd u larvi; uża bħala parti minn programm ta ’ kura tad- dermatite kkawżata minn allerġija għall - briegħed; jista ’ jgħin biex jikkontrolla infestazzjonijiet tal- briegħed fl- ambjent f’ dawk l- inħawi fejn jersaq l- annimal; kura għall- forma adulta tal- ħniex tondi tal- imsaren (Toxocara spp.); prevenzjoni mill- marda tal- heartworm (Dirofilaria immitis); kura għad- dud tal- widnejn (Otodectes cynotis). kura għal qamel li jigdem (Felicola subrostratus; kura għall- forma adulta tal- hookworm fl- imsaren (Ancylostoma tubaeforme).
EU/ 2/ 99/ 014/ 002 (3 tubes) EU/ 2/ 99/ 014/ 008 (6 tubes)
EU/ 2/ 99/ 014/ 002 (3 tubi) EU/ 2/ 99/ 014/ 008 (6 tubi)
22 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON LABEL, 60 mg (ALL PACK SIZES)
TIKKETTA TAL- KAXXA, 60 mg (DAQSIJIET KOLLHA)
Selamectin 60 mg
Selamektin 60 mg
Three tubes each containing 0.5 ml (60 mg selamectin).
Tliet tubi li fihom 0. 5 ml (60 mg selamektin) kull wieħed.
Six tubes each containing 0.5 ml (60 mg selamectin).
Sitt tubi li fihom 0. 5 ml (60 mg selamektin) kull wieħed.
Dogs weighing 5.1 – 10.0 kg.
Klieb li jiżnu bejn 5. 1 kg u 10 kg.
Highly Flammable; keep away from heat, sparks, open flame or other sources of ignition.
Jieħu n- nar malajr: zomm il- bogħod mis- sħana, xrar tan- nar, fjammi jew affarijiet oħra li jistgħu iqabbdu n- nar.
EU/ 2/ 99/ 014/ 004 (3 tubes) EU/ 2/ 99/ 014/ 009 (6 tubes)
EU/ 2/ 99/ 014/ 004 (3 tubi) EU/ 2/ 99/ 014/ 009 (6 tubi)
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
24 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON LABEL, 120 mg (ALL PACK SIZES)
TIKKETTA TAL- KAXXA, 120 mg (DAQSIJIET KOLLHA)
Selamectin 120 mg
Selamektin 120 mg