qanastek/EMEA-V3 huggingface dataset:
Place the tip of the pipette on the skin and squeeze firmly several times to empty the contents directly onto the skin.
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.
Application on the base of the skull will minimise the ability of the cat to lick the product off.
Applikazzjoni fit- tarf tal- kranju tnaqqas l- opportunita ’ ‘ l qattus li jilgħaq il- prodott.
Salivation, vomiting and neurological signs (tremor) were observed occasionally when the product was administered at up to 10 times the recommended dose in adult cats and up to 5 times the recommended dose in kittens.
Tbeżlieq, irreġettar u sinjali newroloġiċi (tregħid) ġew osservati kull tant meta l- prodott ġie applikat sa għaxar darbiet id- doża rrakkomandata fuq qtates adulti u sa 5 darbiet doża rrakkomandata fuq frieħ tal- qtates.
These symptoms were thought to occur as a result of the cat licking the application site.
Is- sintomi huma maħsuba li ġraw meta l- qattus lagħaq il- parti ttrattata.
The symptoms were completely reversible.
Is- sintomi kienu kompletament riversibbli.
There is no known specific antidote.
M ’ hemmx antidot speċifiku li hu magħruf.
4.11 Withdrawal period(s)
4 4. 11 Perjodu ta 'Tiżmim
Pharmacotherapeutic group: therapeutic antiparasitic agent; ATCvet code:
Grupp Farmako- terapewtiku: sustanza terapewtika kontra l- parassiti; Kodici veterinarja ATC:
Emodepside is a semi-synthetic compound belonging to the new chemical group of depsipeptides.
Emodepsajd hija sustanza semi- sintetika li taqa ’ fil- kategorija ġdida ta ’ sustanzi depsipeptidi.
It is active against roundworms (ascarids and hookworms).
Hija attiva kontra l- ħniex.
In this product, emodepside is responsible for the efficacy against Toxocara cati, Toxascaris leonina, and Ancylostoma tubaeforme.
F’ dan il- prodott, emodepsajd hija responsabbli għall- effett kontra Toxocara cati, Toxascaris leonina, u Ancylostoma tubaeforme.
It acts at the neuromuscular junction by stimulating presynaptic receptors belonging to the secretin receptor family which results in paralysis and death of the parasites.
Dan jirriżulta f’ paraliżi u mewt tal- parassita.
Praziquantel is a pyrazinoisoquinoline derivative effective against tapeworms such as Dipylidium caninum, Echinococcus multilocularis, and Taenia taeniaeformis.
Prazikwantel hu mnissel mill- pajrazino- isokwinolin u hu effettiv kontra l- ħniex bħall - Dipylidium caninum, Echinococcus multilocularis, u Taenia taeniaeformis.
Praziquantel is rapidly adsorbed via the surface of the parasites and acts primarily by changing the Ca++ permeability of the parasite membranes.
Prazikwantel hu assorbit faċilment minn fuq il- ġisem tal- parassita u jaħdem primarjament billi jibdel il- livell ta ’ permeabbilita tal- membrana tal- parassita għall- Ca++.
This results in severe damage to the parasite integument, contraction and paralysis, disruption of metabolism and finally leads to the death of the parasite.
Dan jirriżulta fi ħsara kbira fl - integument tal- parassita, kontrazzjoni u paraliżi, tgerfix fil- metaboliżmu, u fl- aħħar iwassal għall - mewt tal- parassita.
After topical application of this product to cats at the minimum therapeutic dose of 0.14 ml/ kg bodyweight, mean maximum serum concentrations of 32.2 ± 23.9 µg emodepside/ l and 61.3 ± 44.1 µg praziquantel/ l were observed.
Wara li tkun saret amministrazzjoni tal- prodott fuq il- ġilda tal- qtates b’ dożaġġ minimu terapewtiku ta ’ 0. 14 ml/ kg piż tal- ġisem, konċentrazzjonijiet massimi fis- serum ta ’ 32. 2 ± 23. 9 µg emidopsajd/ l u 61. 3 ± 44. 1 µg prazikwantel / l ġew osservati.
Maximum concentrations were reached for emodepside 3.2 ± 2.7 days after application and 18.7 ± 47 hours for praziquantel.
L- ogħla konċentrazzjonijiet ta ’ emidopsajd ġew milħuqa 3. 2 ± 2. 7 ġranet wara li saret l- applikazzjoni u 18. 7 ± 47 sigħat għall- prazikwantel.
Both active substances are then slowly eliminated from the serum with a half-life of 9.2 ± 3.9 days for emodepside and 4.1 ± 1.5 days for praziquantel.
Iż- żewġ sustanzi attivi jiġu eliminati bil- mod mis- serum b`nofs- ħajja ta ’ 9. 2 ± 3. 9 granet għall - emidopsajd u 4. 1 ± 1. 5 ġranet għall - prazikwantel.
After oral application in the rat, emodepside is distributed to all organs.
Wara applikazzjoni orali fuq il- far, emidopsajd tiġi mferrxa fl- organi kollha.
Faecal excretion predominates with unchanged emodepside and hydroxylated derivatives as the major excretion products.
L- ogħla konċentrazzjonijiet instabu fix- xaħam. Tneħħija anali tippredomina, fejn emodepsajd u derivattivi ħidrossilati, f’ forma mhux mibdula, kienu l- prodotti ta ’ tneħħija ewlenin.
Studies in many different species show that praziquantel is rapidly metabolised in the liver.
Studji fuq ħafna speċi differenti juru li prazikwantel jiġi metabolizzat malajr fil- fwied.
The main metabolites are monohydroxycyclohexyl derivatives of praziquantel.
Il- metaboliti prinċipali huma derivattivi monohydroxycyclohexyl tal- prazikwantel.
Renal elimination predominates.
Eliminazzjoni renali tippredomina.
5.3 Environmental properties
5. 3 Propjetajiet ambjentali
6.3 Shelf life
5 6. 3 Żmien ta 'kemm il- prodott idum tajjeb
5 6.4 Special precautions for storage
6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
Store in the original package in order to protect from moisture.
Qies tal- pakkett
0.35 ml, 0.70 ml and 1.12 ml per pipette
0. 35 ml, 0. 70 ml u 1. 12 ml kull pipetta
Blister packs containing 2, 4, 12, 20, or 40 unit dose pipettes; 0.70 ml pipette only: additional blister pack containing 80 pipettes
Folji li għandhom pipetta b´doża waħda ta´ 2, 4, 12, 20 jew 40 unit; pipetti ta ’ 0. 70 ml biss; folji oħra addizzjonali li fihom 80 pipetta
Container
Kontenut tal - kontenitur
White polypropylene pipettes with caps in aluminium blisters
Pipetti tal- polipropilin abjad b’ għetien magħmula minn folji ta ’ l- aluminjum.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodott mediċinali veterinarji mhux użati jew materjal ieħor għar- rimi li huwa mnissel minn dan il- prodott
Profender should not be allowed to enter surface water as emodepside has shown harmful effects on aquatic organisms.
Profender m’ għandu qatt jintrema fl- ilma peress li nstab li emodepsajd hu ta´periklu għall- ħut jew ħlejqiet oħra akwatici.
Bayer Animal Health GmbH D-51368 Leverkusen Germany
Bayer Animal Health GmbH D- 51368 Leverkusen Il- Ġermanja
6 [Multi-dose bottle]
6 [Flixkun ta ’ aktar minn doża wahda]
Profender spot-on solution for cats
Profender - taħlita likwida għal użu lokalizzat fuq qtates.
Roundworms (Nematodes) Toxocara cati (mature adult, immature adult, L4 and L3) Toxascaris leonina (mature adult, immature adult and L4) Ancylostoma tubaeforme (mature adult, immature adult and L4)
Ħniex (Nematois) Toxocara cati (adulti maturi, adulti mmaturi, L4 u L3) Toxascaris leonina (adulti maturi, adulti mmaturi u L4) Ancylostoma tubaeforme (adulti maturi, adulti mmaturi u L4)
Tapeworms (Cestodes) Dipylidium caninum (adult) Taenia taeniaeformis (adult) Echinococcus multilocularis (adult)
Ħniex (Cestodi) Dipylidium caninum (adult) Taenia taeniaeformis (adult) Echinococcus multilocularis (adult)
4.4 Special warnings
7 4. 4 Twissijiet speċjali
Shampooing or immersion of the animal in water directly after treatment may reduce the efficacy of the product.
L- użu ta ’ xampu jew l- għads ta ’ l- annimal ġo l- ilma eżatt wara t- trattament, jista´ jnaqqas l- effett tal - prodott.
7 Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Reżistenza tal- parassita għal kull klassi ta ’ antiħelmentiċi tista ’ tiżviluppa meta jkun hemm użu spiss u ripetut ta ’ antiħelmentiċi ta ’ dik il- klassi.
4.7 Use during pregnancy, lactation or lay
4. 7 Użu fit- tqala, fi żmien il- ħalib, jew meta jbidu l- bajd
4.8 Interaction with other medicinal products and other forms of interaction
8 4. 8 Effetti fuq prodotti mediċinali oħra jew effetti oħra
Co-treatment with other drugs that are P-glycoprotein substrates/ inhibitors (for example, ivermectin and other antiparasitic macrocyclic lactones,
Trattament flimkien ma ’ mediċina oħra li hija substrat/ inibitur tal- p- glajkoprotejn (eż. ivermektina, u lattoni makroċikliċi oħra kontra l- parassiti, eritromiċina, prednisolon u ċiklosporin) jista ’ jirriżulta f’ effetti farmakokinetiċi mediċinali.
The recommended minimum doses are 3 mg emodepside / kg body weight and 12 mg praziquantel / kg body weight, equivalent to 0.14 ml Profender / kg body weight.
Id- dożi minimi rrakkmondati huma ta´3 mg emodepsajd għal kull kg piż tal- ġisem u 12 mg prazikwantel għal kull kg piż tal- ġisem, li jiġu ekwivalenti għal 0. 14ml Profender għal kull kg piż tal - ġisem.
Either calculate the exact dose based on the individual body weight, or use the following dose volumes recommended for the different weight ranges:
Jew tikkalkula d- doża eżatta bbażata fuq il- piż individwali tal- ġisem, jew uża id- dożi li ġejjin li huma rrakkomandati għall - skedi ta ’ piż tal- ġisem:
Body Weight Volume
Piż tal - Qattus
Emodepside
Emidopsajd
of Cat (kg) ≥ 0.5 - 2.5 > 2.5 - 5 > 5 - 8
≥0. 5 – 2. 5 > 2. 5 – 5
(ml) 0.35 0.70 1.12
1. 12
(mg) 7.5 15 24
3 – 4. 8
(mg/ kg bw) 12 - 60 12 - 24 12 - 19.2
12 – 19. 2
Appropriate combination of volumes
Agħżel volumi adattati
Take the adapter, remove protective cover from the spike and insert spike into the central area of the stopper.
Neħħi l- l- adaptor, neħħi l- għatu ta ’ protezzjoni minn mal- ponta u dahhal il- ponta fin- nofs tat- tapp.
Remove screw cap.
Neħħi l- għatu bil- kamin.
Take a standard disposable 1 ml syringe with luer nozzle and connect it to the adapter.
Ħu siringa normali, ta użu waħdieni, ta’ 1 ml bil- luer nozzle u poġġiha ma ’ l - adaptor.
Then turn bottle up-side down, and withdraw the necessary volume.
Imbagħad aqleb il- flixkun ta ’ taħt fuq u iġbed il- volum mixtieq.
Replace screw cap after use.
Erġa poġġi l- għatu wara li tispiċċa.
Place the tip of the syringe on the skin and empty the contents directly onto the skin.
Poġġi t- tarf tas- siringa fuq il- ġilda u battal il- kontenut direttament fuq il- ġilda.
Salivation, vomiting and neurological signs (tremor) were observed occasionally when the product was administered at up to 10 times the recommended dose in adult cats and up to 5 times the recommended dose in kittens.
Tbeżlieq, irreġettar u sinjali newroloġiċi (tregħid) ġew osservati kull tant meta l- prodott ġie applikat sa għaxar darbiet id- doża rrakomandata fuq qtates adulti u sa 5 darbiet doża rrakkomandata fuq frieħ tal- qtates.
9 5.1 Pharmacodynamic properties
5. 1 Kwalitajiet Farmakodinamiċi
After oral application in the rat, emodepside is distributed to all organs.
Wara applikazzjoni orali fuq il- far, emidopsajd tiġi mferrexxa fl- organi kollha.
Shelf life after first opening the container:
10 Perjodu ta ’ ħażna wara li jinfetaħ il- kontenitur:
No special precautions for storage.
Dan il- prodott mediċinali veterinarju m ’ għandux bżonn ta ’ l- ebda kondizzjoni speċjali sabiex jinħażen.
10 6.5 Nature and composition of immediate packaging
6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
Pack size:
Qies tal- pakkett:
14 ml Container:
Kontenut tal- kontenitur:
Amber coloured glass bottle with teflon-coated stopper and micro-spike adapter with luer-port
14ml Flixkun tal- ħġieġ kulur isfar b’ tapp miksi bit- teflon u micro- spike adapter bil- luer port
Profender 15 mg/ 3 mg modified-release Tablets for Small Dogs Profender 50 mg/ 10 mg modified-release Tablets for Medium Dogs Profender 150 mg/ 30 mg modified-release Tablets for Large Dogs
Pilloli Profender 15 mg/ 3 mg li jerħu l- mediċina b' mod modifikat għal Klieb Żgħar Pilloli Profender 50 mg/ 10 mg li jerħu l- mediċina b' mod modifikat għal Klieb ta’ daqs Medju Pilloli Profender 150 mg/ 30 mg li jerħu l- mediċina b' mod modifikat għal Klieb Kbar
Each tablet of Profender contains:
Kull pillola Profender fiha:
Profender Tablets for Small Dogs
Pilloli Profender għal Klieb Żgħar
Profender Tablets for Medium Dogs
Pilloli Profender għal Klieb ta’ daqs Medju
Profender Tablets for Large Dogs
Pilloli Profender għal Klieb Kbar
Brown, bone-shaped tablets with a score mark on each side.
Pilloli li jerħu l- mediċina b' mod modifikat Pilloli kannella, forma ta’ għadma mmarkati b’ xaqq fuq kull ġenb.
The tablets can be divided into equal halves.
Il- pilloli jistgħu jinqasmu eżatt minn nofs.
For dogs suffering from, or at risk from, mixed parasitic infections caused by roundworms and tapeworms of the following species:
Għal klieb li qed isofru minn, jew huma f’ riskju minn infezzjonijiet ikkawżati minn ħniex u dud fl- imsaren ta ’ dawn l- ispeċi:
Toxocara canis (mature adult, immature adult, L4 and L3) Toxascaris leonina (mature adult, immature adult and L4) Ancylostoma caninum (mature adult and immature adult) Uncinaria stenocephala (mature adult and immature adult) Trichuris vulpis (mature adult, immature adult)
Ħniex (Nematodi) Toxocara canis (adulti maturi, adulti immaturi, L4 u L3) Toxascaris leonina (adulti maturi, adulti immaturi u L4) Ancylostoma caninum (adulti maturi, adulti immaturi u L4) Uncinaria stenocephala (adulti maturi, adulti immaturi) Trichuris vulpis (adulti maturi, adulti immaturi)
Dipylidium caninum Taenia spp.
Dud (Ċestodi) Dipylidium caninum Taenia spp.
Echinococcus multilocularis (mature adult and immature) Echinococcus granulosus (mature adult and immature)
Echinococcus multilocularis (adulti maturi, adulti immaturi) Echinococcus granulosus (adulti maturi, adulti immaturi) 12 4. 3 Kontra indikazzjonijiet
Do not use in puppies under 12 weeks of age or weighing less than 1 kg.
Tużax fuq ġriewi li għandhom inqas minn 12- il ġimgħa jew li jiżnu inqas minn 1 kg.
Do not use in case of hypersensitivity to the active substances or to any of the excipients.
Tużax f' każijiet ta 'sensittività għall- ingredjent/ i attiv/ i; ingredjenti miżjuda jew ingredjenti oħra
Administer only to fasted dogs.
Amministra biss fuq klieb sajmin.
For example overnight fasting is recommended if the dog is to be treated in the morning.
Per eżempju jekk il- kelb ikun se jiġi ttrattat filgħodu huwa rrikmandat li l- kelb jiġi msajjem matul il- lejl ta’ qabel.
Food may be given 4 hours or more after treatment.
Il- kelb jista ’ mbagħad jingħata l- ikel 4 sigħat jew aktar wara t- trattament.
When D. caninum infection is present, concomitant treatment against intermediate hosts such as fleas and lice should be considered to prevent reinfection.
Caninum hija preżenti, għandu jiġi kkunsidrat trattament kontra l- organiżmi intermedji, bħal briegħed u qamel, biex jilqa ’ kontra infezzjoni mill- ġdid.
No studies have been performed with severely debilitated dogs or individuals with seriously compromised kidney or liver function.
M’ hemm l- ebda studji fuq klieb li huma severement debboli jew individwi li l- funzjoni tal- fwied u l- kliewi tagħhom hija kompromessa.
Therefore, the veterinary medicinal product should only be used in such animals according to a benefit/ risk assessment by the responsible veterinarian.
Għalhekk il- prodott mediċinali veterinarju għandu jiġi użat biss fuq l- annimali wara li tkun saret valutazzjoni tar- riskju/ siwi minn veterinarju responsabbli.
In the interests of good hygiene, wash your hands after administering the tablets to the dog.
Fl- interess ta ’ iġene tajba, aħsel idejk qabel tagħti l- pilloli lill- kelb.
In case of accidental ingestion, especially in the case of children, seek medical advice and show the package leaflet or the label to the physician.
Fil- każ ta ’ indiġestjoni aċċidentali, speċjalment fil- każ tat- tfal, fittex parir mediku u uri l- fuljett tal- pakkett jew t- tikketta lit- tabib.
Echinococcosis represents a hazard for humans.
L- ekinokokkosi hija ta ’ periklu għal bniedem.
As Echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.
Peress li l- ekinokokkosi hija marda li għandha tkun notifikata ’ l- Organizzazzjoni Dinjija għas- Saħħa ta ’ l- Annimali (OIE), tagħrif speċifiku fuq it- trattament u l- follow- up, kif ukoll fuq is- sigurtà tal- persuni għandu jiġi akkwistat mingħand l- awtorità kompetenti relevanti.
4.7 Use during pregnancy or lactation
4. 7 Użu fit- Tqala, fi żmien il- ħalib
The safety of the veterinary medicinal product has not been investigated in pregnant and lactating dogs.
Is- sigurtà tal- prodott mediċinali veterinarju għadha ma ġietx mistħarrġa fuq klieb tqal jew li qegħdin ireddgħu.
Use in these dogs is therefore not recommended.
Għalhekk użu fuq dawn l- annimali m’ huwiex irrikmandat.
Emodepside is a substrate for P-glycoprotein.
Emodepside huwa substrat għal p- glajkoprotejn.
Co-treatment with other drugs that are P-glycoprotein substrates/ inhibitors (for example, ivermectin and other antiparasitic macrocyclic lactones, erythromycin, prednisolone and cyclosporine) could give rise to pharmacokinetic drug interactions.
Trattament flimkien ma ’ mediċini oħra li huma substrat/ inibitur għal p- glajkoprotejn (eż. ivermektin, u lattoni makroċikliċi oħra kontra l- parassiti, eritromiċina, prednisolon u ċiklosporin) jistgħu jirriżultaw f’ effetti farmakokinetiċi fuq xulxin.
The potential clinical consequences of such interactions have not been investigated.
Il- konsegwenzi kliniċi potenzjali t’ effetti bħal dawn għadhom ma ġewx mistħarrġa.
13 4.9 Amounts to be administered and administration route
13 4. 9 Doża rakkomandata u l- metodu ta 'amministrazzjoni
Profender is to be administered at a minimum dose of 1 mg/ kg body weight emodepside and 5 mg/ kg body weight praziquantel, according to the following dosage table.
Profender għandu jiġi amministrat b’ doża minima ta ’ 1 mg/ kg emodepside piż tal- ġisem u 5 mg/ kg praziquantel piż tal- ġisem, skond it- tabella ta’ dożaġġ t’ hawn taħt
Number of Profender tablets for Body Weight (kg)
tal- ġisem (kg)
small dogs
klieb żgħar
medium dogs
klieb ta’ daqs medju
large dogs
klieb
= 10 kg 1
1 = 10 kg 1
1 > 1.5 > 3 > 4.5 > 6 > 10 > 15 > 20 > 30 > 45
1 – > 1. 5 – > 3 – > 4. 5 – > 6 – > 10 – > 15 – > 20 – > 30 – > 45 –
1.5 3 4.5 6 10 15 20 30 45 60
1. 5 3 4. 5 6 10 15 20 30 45 60
For oral use in dogs from 12 weeks of age and weighing at least 1 kg.
Għal użu orali fi klieb li għandhom 12- il- ġimgħa l- fuq u li jiżnu ta ’ l- inqas 1 kg.
Profender tablets are meat flavoured and usually dogs will accept them without any food.
Il- pilloli Profender għandhom togħma ta ’ laħam, u normalment l- klieb ser jaċċettawhom anke jekk mingħajr ikel.
Administer only to fasted dogs.
Amministra fuq klieb sajmin biss.
For example overnight fasting is recommended if the dog is to be treated in the morning.
Per eżempju jekk il- kelb ikun se jiġi trattat filgħodu huwa rrikmandat li l- kelb jiġi msajjem matul il- lejl ta ’ qabel.
Food may be given 4 hours or more after treatment.
Il- kelb jista ’ mbagħad jingħata l- ikel wara 4 sigħat jew aktar li jkun ingħata t- trattament.
Transient muscular tremors, incoordination and depression were occasionally observed when the veterinary product was administered at overdoses of up to 5 times the recommended dose.
Tregħid ta’ muskoli li jgħaddi, nuqqas ta ’ koordinazzjoni u depressjoni ġew osservati kultant meta l- prodott mediċinali ingħata f’ dożi eċċessivi sa 5 darbiet aktar mid- doża rrikmandata.
In mdr1 mutant (-/-) Collies the margin of safety appears lower compared to the normal dog population, with mild transient tremor and/or ataxia occasionally observed after twice the recommended dose.
Fil- Collies bil - mutazzjoni mdr1 (- / -), il- marġini tas- sigurtà jidher aktar baxx meta mqabbel mal- popolazzjoni ta ’ klieb normali, bi tregħid ħafif u/ jew atassja kultant osservati wara li ngħatat doża doppja ta ’ dik rakkomandata.
The symptoms were completely self-resolving without any treatment.
Is- sintomi għaddew weħidhom kompletament mingħajr trattament.
Feeding can increase the incidence and intensity of such overdose symptoms and occasionally vomiting may occur.
It- tmiegħ jista ’ jżid l- inċidenza u l- intensità tas- sintomi ta’ dożi eċċessivi bħal dawn u kultant jista ’ jkun hemm rremettar.
Specific antidotes are not known.
Rimedji speċifiċi m’ humiex magħrufin.
14 5.1 Pharmacodynamic properties
14 5. 1 Kwalitajiet Farmakodinamiċi
Emodepside is a semi-synthetic compound belonging to the new chemical group of depsipeptides.
Emodepside hija sustanza semi- sintetika li tappartjeni lil- grupp ġdid ta ’ sustanzi depsipeptidi.
It is active against roundworms (ascarids, hookworms and whipworms).
Hija attiva kontra n- nematodi (askaridi, anċilostomi u whipworms).
In this product, emodepside is responsible for the efficacy against Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Uncinaria stenocephala and Trichuris vulpis.
F’ dan il- prodott, emodepside hija responsabbli għall- effett kontra Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Uncinaria stenocephala u Trichuris vulpis.
It acts at the neuromuscular junction by stimulating presynaptic receptors belonging to the secretin receptor family which results in paralysis and death of the parasites.
Din is- sustanza taħdem fuq il- konġunġiment newromuskolari billi tistimula ir- riċetturi presinattiċi li jappartjenu fil- kategorija tar- riċetturi tas- sekretin.
Praziquantel is a pyrazinoisoquinoline derivative effective against tapeworms such as Dipylidium caninum, Taenia spp., Echinococcus multilocularis and Echinococcus granulosus.
Praziquantel hu mnissel minn derivat pyrazinoisoquinoline u hu effettiv kontra l- ħniex taċ- ċestodi bħal Dipylidium caninum, Taenia spp., Echinococcus multilocularis u Echinococcus granulosus.
Praziquantel is rapidly adsorbed via the surface of the parasites and acts primarily by changing the calcium (Ca++) permeability of the parasite membranes.
Praziquantel hu assorbit malajr minn fuq il- ġisem tal- parassita u jaħdem primarjament billi jibdel il- permeabbilita tal- kalċju (Ca++) tal- membrana tal- parassita.
This results in severe damage to the parasite integument, contraction and paralysis, disruption of metabolism and finally leads to the death of the parasite.
Dan jirriżulta fi ħsara severa fl- integwiment, kontrazzjoni u paraliżi tal- parassita, tħarbit fil- metaboliżmu, u finalment fil- mewt tal- parassita.
Maximum concentrations were reached 2 hours after treatment for both active substances.
5. 2 Tagħrif Farmakokinetiċi
Both active substances were then eliminated from the plasma with a half-life of 1.4 to 1.7 hours.
Konċetrazzjonijiet massimi ntlaħqu sagħtejn wara t- trattament għaż- żewġ sustanzi attivi.
After oral application in the rat, emodepside is distributed to all organs.
Wara applikazzjoni orali fil- far, emodepside jinfirex fl- organi kollha.
Highest concentration levels are found in the fat.
L- ogħla konċentrazzjonijiet instabu fix- xaħam.
Unchanged emodepside and hydroxylated derivatives are the major excretion products.
Emodepside mhux mibdul u derivati idrossilati tiegħu huma l- prodotti ta ’ eliminazzjoni ewlenin.
The excretion of emodepside has not been investigated in dogs.
L- eliminazzjoni ta ’ emodepside ma ġiex mistħarreġ fil- klieb.
Studies in many different species show that praziquantel is rapidly metabolised in the liver.
Studji fuq ħafna speċi differenti juru li praziquantel jiġi metabolizzat malajr fil- fwied.
The main metabolites are monohydroxycyclohexyl derivatives of praziquantel.
Il- metaboliti prinċipali huma derivati monohydroxycyclohexyl ta ’ praziquantel.
Renal excretion of metabolites predominates.
Eliminazzjoni renali tal- metaboliti tippredomina.
Calcium hydrogen phosphate anhydrous Cellulose, microcrystalline Silica, colloidal anhydrous Croscarmellose sodium Magnesium stearate Povidone Artificial beef flavour
Calcium hydrogen phosphate anidru Cellulose, microcrystalline Silica, colloidal anidru Croscarmellose sodium Magnesium stearate Povidone Togħma artifiċjali taċ- ċanga
15 6.5 Nature and composition of immediate packaging
6. 5 In- natura u l- għamla ta ’ l- ewwel ippakkjar
Cardboard boxes containing aluminium foil blister strips.
Kaxxi tal- kartun li fihom folji ta ’ l- aluminjum.
The following pack sizes are available:
Dawn huma d- daqsijiet tal- pakketti:
Profender 15 mg/3 mg tablets for small dogs
Pilloli Profender 15 mg/ 3 mg għal klieb żgħar
2 tablets 4 tablets 10 tablets 24 tablets 50 tablets
2 pilloli 4 pilloli 10 pilloli 24 pillola 50 pillola
(1 blister strip) (1 blister strip) (1 blister strip) (3 blister strips with 8 tablets each) (5 blister strips with 10 tablets each)
(folja waħda) (folja waħda) (folja waħda) (3 folji bi 8 pilloli kull waħda) (5 folji b’ 10 pilloli kull waħda)
Profender 50 mg/10 mg tablets for medium dogs
Pilloli Profender 50 mg/ 10 mg għal klieb ta ’ daqs medju
2 tablets 4 tablets 6 tablets 24 tablets 102 tablets
2 pilloli 4 pilloli 6 pilloli 24 pillola 102 pilloli
(1 blister strip) (1 blister strip) (1 blister strip) (4 blister strips with 6 tablets each) (17 blister strips with 6 tablets each)
(folja waħda) (folja waħda) (folja waħda) (4 folji ta ’ 6 pilloli kull waħda) (17- il folja ta ’ 6 pilloli kull waħda)
Profender 150 mg/30 mg tablets for large dogs
Pilloli Profender 150 mg/ 30 mg għal klieb kbar
2 tablets 4 tablets 24 tablets 52 tablets
2 pilloli 4 pilloli 24 pillola 52 pillola
(1 blister strip) (1 blister strip) (6 blister strips with 4 tablets each) (13 blister strips with 4 tablets each)
(folja waħda) (folja waħda) (6 folji ta ’ 4 pilloli l- waħda) (13- il folja ta ’ 4 pilloli l- waħda)
Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal- pakketti jistgħu qegħdinfis- suq.
Unused half tablets must not be stored for future use and should be disposed of in accordance with local requirements.
Nofs pilloli mhux użati m’ għandhomx jiġu maħżuna għall- użu fil- ġejjieni u għandhom jintremew skond kif titlob il- liġi tal- pajjiż.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinstab fuq il- websajt ta ’ l- Aġenzija Ewropea għall- Mediċini (EMEA) http: // www. emea. europa. eu /.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL - HRUĠ TAL- LOTT
324 D-24106 Kiel Germany
324 D- 24106 Kiel Il- Ġermanja
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
KONDIZZJONIJIET JEW RESTRIZZJONIJIET TA 'L- AWTORIZZAZZJONI TAL - KUMMERĊ DWAR IL- PROVISTA JEW L- UŻU
To be supplied only on veterinary prescription.
Jigu mogħtija biss bi preskrizzjoni veterinarja.
LABELLING AND PACKAGE LEAFLET
TIKKETTA U L- FULJETT TA ’ TAGĦRIF FIL- PAKETT
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for small cats Outer carton, pack size of 2 (or 4) pipettes
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Profender – taħlita likwida għal użu lokalizzat fuq qtates żgħar Pakkett ta´ barra, pakkett ta´ 2 (jew 4) pipetti.
Profender spot-on solution for small cats
Profender - taħlita likwida għal użu lokalizzat fuq qtates żgħar
Each 0.35 ml pipette contains:
Kull pipetta ta ’ 0. 35 ml fiha:
7.5 mg emodepside, 30 mg praziquantel 5.4 mg/ml butylhydroxyanisole (E320; as antioxidant)
7. 5 mg Emodepsajd, 30 mg Prazikwantel 5. 4 mg/ ml butylhydroxyanisole (E320; bħala antiossidant)
For small cats ≥ 0.5 kg – 2.5 kg
Għall- qtates żgħar ≥ 0. 5 kg – 2. 5 kg
Toxocara cati, Toxascaris leonina, Ancylostoma tubaeforme
Ħniex / (Roundworms) Toxocara cati, Toxascaris leonina, Ancylostoma tubaeforme
Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis
Ħniex / (Tapeworms) Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis
For the complete indication, including the larval stages, read the package leaflet.
Għall- indikazzjoni kompleta, inklużiv l- istadji tal- larva, aqra l- fuljett ta´tagħrif ġol- pakket.
Read the package leaflet before use.
Aqra l- fuljett ta´tagħrif ġol- pakkett qabel tuża.
EXP {month/year}
Jiskadi {xahar / sena}
Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali biex tipproteġi mill- umdita.
Bayer Animal Health GmbH, D-51368 Leverkusen, Germany
Bayer Animal Health GmbH, D- 51368 Leverkusen, Il- Ġermanja
23 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for small cats Outer carton, pack size of 12 (20 or 40) pipettes
23 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Profender – taħlita likwida għal użu lokalizzat fuq qtates żgħar Pakkett ta´ barra, pakkett ta´ 12 (20 jew 40) pipetti.
Profender spot-on solution for small cats
Profender – taħlita likwida għal użu lokalizzat fuq qtates żgħar
12 pipettes 20 pipettes 40 pipettes
12 - il- pipetta 20 pipetta 40 pipetta
For the complete indication, including the larval stages, read the package leaflet.
Għall- indikazzjoni kompleta, inklużiv l- istadji tal- larva, aqra l- fuljett ta´tagħrif ġol- pakkett.
For user safety warnings – read the package leaflet before use.
Għas- sigurta ’ ta ’ min juża l- prodott - aqra l- fuljett ta´tagħrif ġol- pakkett qabel tuża ’.
EU/2/05/054/003 12 pipettes EU/2/05/054/004 20 pipettes EU/2/05/054/005 40 pipettes
EU/ 2/ 05/ 054/ 003 12 – il pipetta EU/ 2/ 05/ 054/ 004 20 pipetta EU/ 2/ 05/ 054/ 005 40 pipetta
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for medium cats Outer carton, pack size of 2 (or 4) pipettes
25 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Profender – taħlita likwida għal użu lokalizzat fuq qtates ta ’ daqs medju Pakkett ta´ barra, pakkett ta´ 2 (jew 4) pipetti.
Profender spot-on solution for medium cats
Profender - taħlita likwida għal użu lokalizzat fuq qtates ta ’ daqs medju
Each 0.70 ml pipette contains:
Kull pipetta ta ’ 0. 70 ml fiha:
15 mg emodepside, 60 mg praziquantel 5.4 mg/ml butylhydroxyanisole (E320; as antioxidant)
15 mg emodepsajd, 60 mg prazikwantel 5. 4 mg/ ml butylhydroxyanisole (E320; bħala antiossidant)
For medium cats > 2.5 kg – 5 kg
Għall- qtates ta ’ daqs medju > 2. 5 kg – 5 kg
For the complete indication, including the larval stages, read the package leaflet.
Għall- indikazzjoni kompleta, inklużiv l- istadji tal- larva, aqra l- fuljett ta ’ tagħrif ġol- pakkett.
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif ġol- pakkett qabel tuża.
Store in the original package in order to protect from moisture.
Aħżen fil- pakkett oriġinali biex tipproteġi mill- umdita..
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for medium cats Outer carton, pack size of 12 (20, 40 or 80) pipettes
27 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Profender – taħlita likwida għal użu lokalizzat fuq qtates ta ’ daqs medju Pakkett ta´ barra, pakkett ta´ 12 (20, 40 jew 80) pipetta.
Profender spot-on solution for medium cats
Profender – taħlita likwida għal użu lokalizzat fuq qtates ta ’ daqs medju
12 pipettes 20 pipettes 40 pipettes 80 pipettes
12 – il pipetta 20 pipetta 40 pipetta 80 pipetta
For user safety warnings – read the package leaflet before use.
Għas- sigurta ’ ta ’ min juża l- prodott - aqra l- fuljett ta´ tagħrif ġol- pakkett qabel tuża ’.
EU/2/05/054/008 12 pipettes EU/2/05/054/009 20 pipettes EU/2/05/054/010 40 pipettes EU/2/05/054/011 80 pipettes
EU/ 2/ 05/ 054/ 008 12 – il pipetta EU/ 2/ 05/ 054/ 009 20 pipetta EU/ 2/ 05/ 054/ 010 40 pipetta EU/ 2/ 05/ 054/ 011 80 pipetta
29 17.
29 17.
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for large cats Outer carton, pack size of 2 (or 4) pipettes
30 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Profender – taħlita likwida għal użu lokalizzat fuq qtates kbar Pakkett ta´ barra, pakkett ta´ 2 (jew 4) pipetti.
Profender spot-on solution for large cats
Profender - taħlita likwida għal użu lokalizzat fuq qtates kbar
Each 1.12 ml pipette contains:
Kull pipetta ta ’ 1. 12 ml fiha:
24 mg emodepside, 96 mg praziquantel 5.4 mg/ml butylhydroxyanisole (E320; as antioxidant)
24 mg emodepsajd, 96 mg prazikwantel 5. 4 mg/ ml butylhydroxyanisole (E320; bħala antiossidant)
For large cats > 5 kg – 8 kg
Għall- qtates kbar > 5kg – 8 kg
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for large cats Outer carton, pack size of 12 (20 or 40) pipettes
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Profender – taħlita likwida għal użu lokalizzat fuq qtates kbar Pakkett ta´ barra, pakkett ta´ 12 (20 jew 40) pipetta.
Profender spot-on solution for large cats
Profender – taħlita likwida għal użu lokalizzat fuq qtates kbar
For large cats > 5 kg – 8 kg
Għall- qtates kbar > 5 kg – 8 kg
EU/2/05/054/014 12 pipettes EU/2/05/054/015 20 pipettes EU/2/05/054/016 40 pipettes
EU/ 2/ 05/ 054/ 014 12 – il pipetta EU/ 2/ 05/ 054/ 015 20 pipetta EU/ 2/ 05/ 054/ 016 40 pipetta
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for cats Outer carton, Multi-dose bottle
34 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Profender – taħlita likwida għal użu lokalizzat fuq qtates Kaxxa ta´ barra, flixkun ta ’ aktar minn doża wahda.
Profender spot-on solution for cats
Profender – taħlita likwida għal użu lokalizzat fuq qtates
21.4 mg/ml emodepside, 85.8 mg/ml praziquantel 5.4 mg/ml butylhydroxyanisole (E320; as antioxidant)
21. 4 mg/ ml emodepsajd, 85. 8 mg/ ml prazikwantel 5. 4 mg/ ml butylhydroxyanisole (E320: bħala antiossidant)
For user safety warnings – read the package leaflet before use.
Għas- sigurta ’ ta ’ min juża l- prodott - aqra l- fuljett ta ’ tagħrif ġol- pakkett qabel tuża ’.
3 months
Jiskadi {xahar / sena} Uża sa tlett xhur wara li tkun ftaħt il- flixkun.
36 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Profender spot-on solution for small cats Pipette label
36 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Profender for cats (≥ 0.5 – 2.5 kg)
Profender għal qtates (≥ 0. 5 – 2. 5 kg)
EXP {month/year}
EXP {xahar/ sena}
THE WORDS “FOR ANIMAL TREATMENT ONLY”
IL- KLIEM "GĦAL TRATTAMENT TAL- ANNIMALI BISS ”
37 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Profender spot-on solution for medium cats Pipette label
37 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Profender for cats (> 2.5 –5 kg)
Profender għall- qtates (> 2. 5 – 5 kg)
38 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Profender spot-on solution for large cats Pipette label
38 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Profender for cats (> 5 – 8 kg)
Profender għall- qtates (> 5 – 8 kg)
EXP IRY DATE
DATA TA 'SKADENZA
39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Profender spot-on solution for cats Bottle label
39 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR Profender – taħlita għal użu lokalizzat għall - qtates Tikketta tal- flixkun
Profender spot-on solution for cats
Profender – taħlita għal- użu lokalizzat għall - qtates
21.4 mg/ml emodepside, 85.8 mg/ml praziquantel
21. 4 mg/ ml emodepsajd, 85. 8 mg/ ml prazikwantel
Spot-on use.
Għal- użu lokalizzat.
EXP {month/year}
DATA TA 'SKADENZA
Once opened, use by…………….{leave space for the date to be inserted}.
EXP {xahar/ sena} Jekk miftuħ uża sal -............................. {ħalli spazju biex titniżzel id- data.}
40 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Profender spot-on solution for small cats blister
40 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS Profender – taħlita likwida għal użu lokalizzat fuq qtates żgħar Folji
Profender for small cats (≥0.5 - 2.5 kg)
Profender – għall- qtates żgħar (≥0. 5 – 2. 5kg)
{month/year}
{xahar/ sena}
For animal treatment only.
Ghat- trattament ta ’ l- annimali biss.
41 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Profender spot-on solution for medium cats blister
Folji
Profender for medium cats (> 2.5 - 5 kg)
Profender – għall- qtates ta ’ daqs medju (> 2. 5 – 5 kg)
42 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Profender spot-on solution for large cats blister
42 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS Profender – taħlita likwida għal użu lokalizzat fuq qtates kbar Folji
Profender for large cats (> 5 - 8 kg)
Profender – għall- qtates kbar (> 5 – 8 kg)
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 15 mg / 3 mg Tablets for Small Dogs Outer carton, pack size of 2 (or 4) tablets
43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Pilloli Profender 15 mg/ 3 mg għal Klieb Żgħar Pakkett ta´ barra, pakkett ta´ 2 (jew 4) pilloli
Profender 15 mg / 3 mg modified-release Tablets for Small Dogs
Pilloli Profender 15 mg/ 3 mg li jerħu l- mediċina b' mod modifikat għal Klieb Żgħar
3 mg emodepside, 15 mg praziquantel.
3 mg emodepside u 15mg praziquantel.
For the complete indication, including species and larval stages, read the package leaflet.
Kura kontra ħniex u dud ta ’ l- imsaren Għall- indikazzjoni kompleta, li tinkludi l- ispeċi u stadji tal- larva, aqra l- fuljett ta´ tagħrif.
Read the package leaflet before use.
Għal- użu orali Qabel l- użu aqra l- fuljett li jinsab fil- pakkett
Read package leaflet.
Aqra l- fuljett ta ’ tagħrif.
EU/2/05/054/018 2 tablets EU/2/05/054/019 4 tablets
EU/ 2/ 05/ 054/ 018 2 pilloli EU/ 2/ 05/ 054/ 019 4 pilloli
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 15 mg / 3 mg Tablets for Small Dogs Outer carton, pack size of 10 (24 or 50) tablets
45 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Pilloli Profender 15 mg/ 3 mg għal Klieb Żgħar Pakkett ta´ barra, pakkett ta´ 10 pilloli (24 jew 50 pillola)
3 mg emodepside, 15 mg praziquantel.
3 mg emodepside u 15 mg praziquantel.
10 tablets 24 tablets 50 tablets
10 pilloli 24 pillola 50 pillola
EXP {month/year}
Jiskadi {xahar/ sena}
Read package leaflet.
Aqra l- fuljett tal- pakkett.
EU/2/05/054/020 10 tablets EU/2/05/054/021 24 tablets EU/2/05/054/022 50 tablets
EU/ 2/ 05/ 054/ 020 10 pilloli EU/ 2/ 05/ 054/ 021 24 pillola EU/ 2/ 05/ 054/ 022 50 pillola
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 50 mg / 10 mg Tablets for Medium Dogs Outer carton, pack size of 2 (or 4) tablets
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Pilloli Profender 50 mg/ 10 mg għal Klieb ta ’ daqs Medju Pakkett ta´ barra, pakkett ta´ 2 (jew 4) pilloli
Profender 50 mg / 10 mg modified-release Tablets for Medium Dogs
Pilloli Profender 50 mg/ 10 mg li jerħu l- mediċina b' mod modifikat għal Klieb ta’ daqs Medju
10 mg emodepside, 50 mg praziquantel.
10 mg emodepside u 50 mg praziquantel.
For the complete indication, including species and larval stages, read the package leaflet.
Kura kontra ħniex u dud ta ’ l- imsaren Għall- indikazzjoni kompleta, li jinkludi l- ispeċi u stadji tal- larva, aqra l- fuljett ta´ tagħrif.
EU/2/05/054/023 2 tablets EU/2/05/054/024 4 tablets
EU/ 2/ 05/ 054/ 023 2 pilloli EU/ 2/ 05/ 054/ 024 4 pilloli
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 50 mg / 10 mg Tablets for Medium Dogs Outer carton, pack size of 6 (24 or 102) tablets
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Pilloli Profender 50 mg/ 10 mg għal Klieb ta’ daqs Medju Pakkett ta´ barra, pakkett ta´ 6 pilloli (24 jew 102 pillola)
6 tablets 24 tablets 102 tablets
6 pilloli 24 pillola 102 pilloli
For the complete indication, including species and larval stages, read the package leaflet.
Kura kontra ħniex u dud ta ’ l- imsaren Għall- indikazzjoni kompleta, li jinkludi l- ispeċi u stadji tal- larva, aqra l- fuljett ta´tagħrif.
EU/2/05/054/025 6 tablets EU/2/05/054/026 24 tablets EU/2/05/054/027 102 tablets
EU/ 2/ 05/ 054/ 025 6 pilloli EU/ 2/ 05/ 054/ 026 24 pillola EU/ 2/ 05/ 054/ 027 102 pilloli
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 150 mg / 30 mg Tablets for Large Dogs Outer carton, pack size of 2 tablets
51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Pilloli Profender 150 mg/ 30 mg għal Klieb Kbar Pakkett ta´ barra, pakkett ta´ 2 pilloli
Profender 150 mg / 30 mg modified-release Tablets for Large Dogs
Pilloli Profender 150 mg / 30 mg li jerħu l- mediċina b' mod modifikat għal Klieb Kbar
30 mg emodepside, 150 mg praziquantel.
30 mg emodepside u 150 mg praziquantel.
For the complete indication, including species and larval stages, read the package leaflet.
Kura kontra ħniex u dud ta ’ l- imsaren Għall- indikazzjoni kompleta, li jinkludu l- ispeċi u stadji tal- larva, aqra l- fuljett ta´ tagħrif.
EU/2/05/054/028 2 tablets
EU/ 2/ 05/ 054/ 028 2 pilloli
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 150 mg / 30 mg Tablets for Large Dogs Outer carton, pack size of 4 (24 or 52) tablets
53 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA Pilloli Profender 150 mg/ 30 mg għal Klieb Kbar Pakkett ta´ barra, pakkett ta´ 4 pilloli (24 jew 52 pillola)
30 mg emodepside, 150 mg Praziquantel.
30 mg emodepside u 150 mg praziquantel.
4 tablets 24 tablets 52 tablets
4 pilloli 24 pillola 52 pillola
Do not use in puppies under 12 weeks of age or weighing less than 1 kg.
54 Tużax fuq ġriewi li għandhom inqas minn 12- il ġimgħa jew li jiżnu inqas minn 1 kg.
EU/2/05/054/029 4 tablets EU/2/05/054/030 24 tablets EU/2/05/054/031 52 tablets
EU/ 2/ 05/ 054/ 029 4 pilloli EU/ 2/ 05/ 054/ 030 24 pillola EU/ 2/ 05/ 054/ 031 52 pillola
55 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Profender 15 mg / 3 mg Tablets for Small Dogs Blister
55 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS Pilloli Profender 15 mg/ 3 mg għal Klieb Żgħar Folji
EXP {month/year}
{xahar/ sena}
56 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Profender 50 mg / 10 mg Tablets for Medium Dogs Blister
56 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS Pilloli Profender 50 mg/ 10 mg għal Klieb ta’ daqs Medju Folji
57 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Profender 150 mg / 30 mg Tablets for Large Dogs Blister
57 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW L- ISTRIPS Pilloli Profender 150 mg/ 30 mg għal Klieb Kbar Folji
59 [Single-dose pipettes]
59 [Pipetti ta ’ doża waħda]
PACKAGE LEAFLET Profender spot-on solution for small cats Profender spot-on solution for medium cats Profender spot-on solution for large cats
Profender - taħlita likwida għal użu lokalizzat fuq qtates kbar.
Profender contains 21.4 mg/ml emodepside and 85.8 mg/ml praziquantel.
Profender fih 21. 4 mg/ ml emodepsajd u 85. 8 mg/ ml prazikwantel.
Each unit dose (pipette) of Profender delivers:
Kull doża (pipetta) ta´ Profender fiha:
Profender for Medium Cats (> 2.5 – 5 kg)
Profender għall- qtates ta ’ daqs medju (> 2. 5 - 5 kg)
5.4 mg/ml butylhydroxyanisole (E320; as antioxidant)
5. 4 mg/ ml butylhydroxyanisole (E320; bħala antiossidant)
For cats suffering from, or at risk from, mixed parasitic infections caused by roundworms and tapeworms of the following species:
Għal qtates li qed isofru minn, jew huma fil- periklu ta´ infezzjonijiet kawżati minn parassiti diversi ikkawżati minn ħniex ta ’ dawn l- ispeċi hawn taħt:
In very rare cases following administration of Profender transient alopecia, pruritus and/or inflammation were observed at the application site.
Huwa maħsub li dan jiġri meta l- qattus jilgħaq partijiet t’ applikazzjoni, direttament wara t- trattament. F`każijiet rarissimi ġew osservati alopecia riversibbli, pruritus u/ jew infjammazzjoni fejn ġie applikat il- prodott.
DOSAGE, ROUTE AND METHOD OF ADMINISTRATION
DOŻA, MOD U METODU TA 'AMMINISTRAZZJONI
The recommended minimum doses are 3 mg emodepside / kg body weight and 12 mg praziquantel / kg body weight, equivalent to 0.14 ml Profender / kg body weight.
Id- dożi minimi rrakkomandati huma ta´ 3 mg emodepsajd għal kull kg piż tal- ġisem u 12 mg prazikwantel għal kull kg piż tal- ġisem, li jiġu ekwivalenti għal 0. 14ml Profender għal kull kg piż tal - ġisem.
Emodepside (mg/kg bw)
[mg/ kg piż tal - ġisem]
Praziquantel (mg/kg bw)
[mg/ kg piż tal - ġisem]
≥0.5 - 2.5 > 2.5 - 5 > 5 - 8
≥0. 5 – 2. 5 > 2. 5 - 5
0. 35 0.70 1.12
1. 12
A single administration per treatment is effective.
61 Amministrazzjoni waħda għal kull trattament hija effettiva.
Hold pipette in upright position, twist and pull off cap and use the opposite end of the cap to break the seal.
Aqleb l - għatu ta´ taħt fuq u użah biex tilwi u tneħhi s- siġill tal- pipetta.
Part the fur on the cat’s neck at the base of the skull until the skin is visible.
Ofroq il- pil fuq l- għonq tal- qattus fit- tarf tal- kranju sakemm tidher il- ġilda.
Place the tip of the pipette on the skin and squeeze firmly several times to empty the contents directly onto the skin.
Poġġi t- tarf tal- pipetta fuq il- ġilda u għafas il- pipetta bis- sħih kemm il- darba biex tbattal il- kontenut direttament fuq il- ġilda.
Application on the base of the skull will minimise the ability of the cat to lick the product off.
Applikjazzjoni fit- tarf tal- kranju tnaqqas l- opportunita` ´l qattus li jilgħaq il- prodott.
Store in the original package in order to protect from moisture.
Aħżen fil- pakkett originali biex tipproteġi mill- umdita.
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 benefit-risk assessment for these animals.
Għalhekk dan il - prodott għandu biss jiġi wżat wara valutazzjoni tar- riskju u benefiċċju fuq dawn l- annimali.
Shampooing or immersion of the animal in water directly after treatment may reduce the efficacy of the product.
L- użu ta ‘ xampu jew l- għads ta ’ l- annimal ġo l- ilma eżatt wara t- trattament, jista´ jnaqqas l- effett tal - prodott.
Avoid direct contact with application area while it is wet.
62 Evita kuntatt dirett mal- parti fejn tapplika l- prodott, meta din tkun imxarrba.
62 If the product accidentally gets into eyes, they should be thoroughly flushed with plenty of water.
F’ każ li l- prodott jiġu f’ kuntatt ma ’ l- għajnejn, baħbaħ malajr b’ ħafna ilma.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS
PREKAWZJONIJIET SPEĊJALI DWAR RIMI TA 'PRODOTT MHUX UŻAT JEW MATERJAL IEĦOR GĦAR- RIMI
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
L- AĦĦAR DATA META ĠIE APPROVAT IL- FULJETT INFORMATTIV FIL - PAKKETT
Profender can be used during pregnancy and lactation.
Profender jista ’ jintuża waqt it- tqala u fi żmien il- ħalib.
België/Belgique/Belgien Bayer SA-NV Louizalaan, 143, avenue Louise B–1050 Brussel/Bruxelles/Brüssel Tel/Tél: +32 2 535 66 54
63 België/ Belgique/ Belgien Bayer SA- NV Louizalaan, 143, avenue Louise B– 1050 Brussel/ Bruxelles/ Brüssel Tel/ Tél: +32 2 535 66 54
Eesti Österreich Magnum Veterinaaria AS Vae 16 EE-76401 Laagri Tel: +372 650 1920
Magnum Veterinaaria AS Vae 16 EE- 76401 Laagri Tel: +372 650 1920
France Bayer Santé Division Santé Animale 13, rue Jean Jaurès F–92807 Puteaux cédex Tél: +33 1 49 06 58 19
64 France Bayer Santé Division Santé Animale 13, rue Jean Jaurès F– 92807 Puteaux cédex Tél: +33 1 49 06 58 19
65 [Multi-dose bottle]
65 [Flixkun ta ’ aktar minn doża wahda.]
PACKAGE LEAFLET Profender spot-on solution for cats
FULJETT TA ’ TAGĦRIF FIL- PAKKETT Profender - taħlita likwida għal użu lokalizzat fuq qtates
Profender spot-on solution for cats
Profender - taħlita likwida għal użu lokalizzat fuq qtates
DOSAGE, ROUTE AND METHOD OF ADMINISTRATION
DOŻA, MOD) U METODU TA 'AMMINISTRAZZJONI
Dosage and Treatment Schedule
Skeda tad- doża utrattament
The recommended minimum doses are 3 mg emodepside / kg body weight and 12 mg praziquantel / kg body weight, equivalent to 0.14 ml Profender / kg body weight.
Id- dożi minimi rrakkmandati huma ta´ 3mg emodepsajd għal kull kg piż tal- ġisem u 12 mg prazikwantel għal kull kg piż tal- ġisem, li jiġu ekwivalenti għal 0. 14ml Profender għal kull kg piż tal - ġisem.
of Cat (kg) ≥0.5 - 2.5 > 2.5 - 5 > 5 - 8
≥0. 5 – 2. 5 > 2. 5 – 5
(mg/kg bw) 12 - 60 12 - 24 12 - 19.2
12 – 19. 2
Take the adapter, remove protective cover from the spike and insert spike into the central area of the stopper (1).
Neħħi l- l- adaptor, neħħi l- għatu ta ’ protezzjoni minn mal- ponta u dahhal il- ponta fin- nofs tat- tapp (1).
Remove screw cap (2).
Neħħi l- għatu bil- kamin (2).
Take a standard disposable 1 ml syringe with luer nozzle and connect it to the adapter (3).
Ħu siringa normali, ta użu waħdieni, ta’ 1 ml bil- luer nozzle u poġġiha ma ’ l- adaptor (3).
Then turn bottle up-side down, and withdraw the necessary volume (4).
Imbagħad aqleb il- flixkun ta ’ taħt fuq u iġbed il- volum mixtieq (4).
Replace screw cap after use.
Erġa poġġi l - għatu wara li tispiċċa.