qanastek/EMEA-V3 huggingface dataset:
Place the tip of the syringe on the skin and empty the contents directly onto the skin (5).
Poġġi t- tarf tas- siringa fuq il- ġilda u battal il- kontenut direttament fuq il- ġilda (5).
67 Application on the base of the skull will minimise the ability of the cat to lick the product off.
67 Applikazzjoni fit- tarf tal- kranju tnaqqas l- opportunita ’ ‘ l qattus li jilgħaq il- prodott.
3 months
Meta tiftaħ il- pakkett uża sa tlett xhur.
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.
05.09.08
16/ 01/ 2007
Lyngby
Danmark Bayer A/ S, Bayer HealthCare Animal Health Division Nørgaardsvej 32
Nederland Bayer B.V., Animal Health Division Energieweg 1 NL-3641 RT Mijdrecht Tel: +31 297 280 467
Nederland Bayer B. V., Animal Health Division Energieweg 1 NL- 3641 RT Mijdrecht
70 Tel: +39 02 3978 1
70 I- 20156 Milano Tel: +39 02 3978 1
FIN-20101 Turku/Åbo Puh/Tel: +358 10 4261
Tengströminkatu 8, PL/ PB 425 FIN- 20101 Turku/ Åbo Puh/ Tel: +358 10 4261
71 PACKAGE LEAFLET Profender Modified-Release Tablets for Dogs
71 FULJETT TA ’ TAGĦRIF FIL- PAKKETT Pilloli Profender li jerħu l- mediċina b' mod modifikat għal- Klieb
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
1 L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ, U L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI LI JĦALLI L- KONSENJA TMUR FIS- SUQ, JEKK DIFFERENTI
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
STATEMENT OF THE ACTIVE SUBSTANCES
3 DIKJARAZZJONI TAS- SUSTANZI ATTIVI
INDICATIONS
4 INDIKAZZJONIJIET
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 ħbiex 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 u adulti mmaturi) Uncinaria stenocephala (adulti maturi, adulti immaturi) Trichuris vulpis (adulti maturi, adulti immaturi)
Dipylidium caninum Taenia spp.
72 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)
Do not use in case of hypersensitivity to the active substances or to any of the excipients.
Tużax f' każijiet ta 'sensittivita għall- ingredjent/ i attiv/ i; ingredjenti miżjuda jew ingredjenti oħra
DOSAGE, ROUTE AND METHOD OF ADMINISTRATION
8 DOŻA, MOD U METODU TA 'AMMINISTRAZZJONI
For oral use in dogs from 12 weeks of age and weighing at least 1 kg.
Sabiex jingħata mill- ħalq lil ġriewi li għandhom aktar minn 12- il ġimgħa jew li jiżnu ta ’ l- inqas 1 kg.
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 jingħata 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)
Numru ta ’ pilloli profender għal Piż tal- ġisem (kg)
large dogs
klieb kbar
= 3 kg 1
1 = 10 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 mingħajr ikel.
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 msawwam matul il- lejl ta’ qabel.
Store in the original package in order to protect from moisture.
Aħżen fil- pakkett originali biex tipproteġi mill- umdità.
Do not use after the expiry date stated on the carton or blister.
Tużax wara d- data ta ’ l- iskadenza fuq it- tikketta u fuq il- pakkett jew folja.
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.
The safety of this 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 l- użu fuq dawn l- annimali mhux rakkomandat.
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 huma kompromessi.
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 ta’ riskju/ siwi minn veterinarju responsabbli.
Temporary trembling, incoordination and depression were occasionally observed when the veterinary product was administered at overdoses of up to 5 times the recommended dose.
Tregħid temporanju li jgħaddi, nuqqas ta ’ koordinazzjoni u depressjoni ġew osservati kultant meta l- prodott mediċinali ġie amministrat f’ dożi żejda, 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.
Feeding can increase the frequency and intensity of such overdose symptoms and occasionally vomiting may occur.
It- tmiegħ jista ’ jżid l- inċidenza u l- intensità ta’ dożi żejda bħal dawn u kultant jista ’ jkun hemm rremettar.
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 jipproteġi kontra infezzjoni oħra.
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.
To the user:
Lil min jamministra l- prodott:
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’ inġestjoni aċċidentali, speċjalment fil- każ tat- tfal, fittex parir mediku u uri l- fuljett tal- pakkett jew it- tikketta lit- tabib.
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
(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 ta ’ 8 pilloli kull waħda) (5 folji ta ’ 10 pilloli kull waħda)
(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)
What is ProMeris Duo?
X’ inhu ProMeris Duo?
ProMeris Duo is a clear, yellow-to-amber solution that contains metaflumizone and amitraz as active substances.
ProMeris Duo huwa soluzzjoni trasparenti ta ’ lewn isfar jagħti fl- ambra li fih is- sustanzi attivi metaflumizone u amitraz.
It is given to dogs with a pre-filled spot-on pipette, a small plastic container that is already filled with the correct amount of ProMeris Duo needed to treat one dog.
Jingħata lil klieb permezz ta ’ pipetti għal użu lokalizzat (spot- on) mimlija minn qabel, kontenitur tal- plastik żgħir li jkun mimli minn qabel bl- ammont meħtieġ ta ’ ProMeris Duo għat- trattament ta ’ kelb wieħed.
ProMeris Duo is available in five different sizes for various weights of dog.
ProMeris Duo huwa disponibbli f’ ħames daqsijiet skont il- piż tal- kelb.
The contents of the pipette are squeezed onto the skin after parting the fur at the back of the head.
Il- kontenut tal- pipetta jintgħafsu għal ġol- ġilda wara li jkun inferaq il- pil fuq in- naħa ta ’ wara tar- ras.
What is ProMeris Duo used for?
Għal xiex jintuża ProMeris Duo?
ProMeris Duo is an ‘ ectoparasiticide’.
ProMeris Duo huwa “ ektoparasitiċid ” (ectoparasiticide).
This means that it will kill parasites that live on or in the skin or in the fur of animals, such as fleas, ticks, lice and Demodex mites (mites that cause demodicosis or ‘ mange’).
Dan ifisser li joqtol il- parassiti li jgħixu fuq jew fil- ġilda jew il- pil tal- annimali, bħall- briegħed, qurdien, qamel u dud Demodex (dud li jikkawża demodiċożi jew “ ġarab ”).
ProMeris Duo is used in dogs over eight weeks of age to treat and to prevent tick and flea infestations, and to treat demodicosis (caused by Demodex mites) and lice infestations.
ProMeris Duo jintuża fil- klieb ta ’ aktar minn tmien ġimgħat biex jittratta u jipprevjeni impestazzjoni ta ’ qurdien u briegħed, u biex jitratta d- demodiċożi (ikkawżat minn dud Demodex) u impestazzjoni ta ’ qamel.
It can also be used as part of a treatment strategy for the control of flea allergy dermatitis, an allergic reaction to flea bites.
Jista ’ jintuża wkoll bħala parti minn strateġija ta ’ trattament għall- kontroll ta ’ dermatite allerġija tal- briegħed, reazzjoni allerġika għall- qris mill - briegħed.
How does ProMeris Duo work?
Kif jaħdem ProMeris Duo?
Both active substances in ProMeris Duo, metaflumizone and amitraz, interfere with the neural activity of the parasites and consequently lead to their death.
Iż- żewġ sustanzi attivi fi ProMeris Duo, metaflumizone u amitraz, jinterferixxu mal- attività tan- nervituri fil- parassiti u konsegwentement jirriżulta fil- mewt tagħhom.
How has ProMeris Duo been studied?
Kif ġie studjat ProMeris Duo?
Data were provided on pharmaceutical quality, the safety of the medicine in dogs and its safety in humans (people who come into contact with the medicine) and in the environment.
Ġiet ipprovduta dejta dwar il- kwalità farmaċewtika, is- sigurtà tal- mediċina fil- klieb u s- sigurtà tagħha fil- bniedem (nies li jkollhom kuntatt dirett mal- mediċina) u fl- ambjent.
The effectiveness of ProMeris Duo against flea, lice and tick infestations and Demodex mites has been studied in a number of studies, including one study in dogs infested with fleas or ticks carried out at veterinary practices in Germany and France.
L- effikaċja ta ’ ProMeris Duo kontra impestazzjonijiet ta ’ briegħed, qamel u qurdien u dud Demodex ġiet studjata f’ għadd ta ’ studji, inkluż studju wieħed fil- klieb li kellhom il- briegħed jew il- qurdien li twettaq fi kliniċi veterinarji fil- Ġermanja u Franza.
The effectiveness was 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Klieb ta ’ diversi razez, 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. measured looking at the clinical signs and the number of Demodex mites in skin scrapings taken every four weeks, for several weeks following monthly administration of the treatment.
Reproduction is authorised provided the source is acknowledged. etajiet u piżijiet ingħataw ProMeris Duo jew mediċini oħra awtorizzati fl- Unjoni Ewropea (UE) għall- impestazzjoni ta ’ briegħed u qurdien.
A further study compared the effectiveness of ProMeris Duo with that of fipronil (another medicine for the treatment of lice).
Studju ieħor qabbel l- effikaċja ta ’ ProMeris Duo ma ’ dik ta ’ fipronil (mediċina oħra għat - trattament tal- qamel).
The effectiveness was measured by looking at the number of lice on the dogs after treatment.
L- effikaċja tkejlet billi ġie osservat l- għadd ta ’ qamel fuq il- klieb wara t- trattament.
What benefit has ProMeris Duo shown during the studies?
X’ benefiċċju wera ProMeris Duo waqt l- istudji?
The results of the studies showed that ProMeris Duo is effective in the treatment and prevention of flea and tick infestations, and in the treatment of demodicosis and lice infestation in dogs.
Ir- riżultati tal- istudji wrew li ProMeris Duo huwa effikaċi fit- trattament u l- prevenzjoni ta ’ impestazzjonijiet ta ’ briegħed u qurdien, u fit- trattament tad- demodiċożi u impestazzjoni tal - qamel fil- klieb.
The medicine killed most fleas within 24 hours, most ticks within 48 hours and most lice within a week of treatment.
Il- mediċina qatlet il- biċċa l- kbira tal- briegħed fi żmien 24 siegħa, il - maġġoranza tal- qurdien fi żmien 48 siegħa u l- parti l- kbira tal- qamel fi żmien ġimgħa ta ’ trattament.
Demodicosis was usually cured within three to six months of treatment.
Il- kura tad- demodiċożi normalment tieħu bejn tlieta u sitt xhur ta ’ trattament.
The effectiveness of ProMeris Duo lasted for at least six weeks against fleas and for four weeks against ticks.
L - effikaċja bi ProMeris Duo dam talinqas sitt ġimgħat kontra l- briegħed u erba ’ ġimgħat għall - qurdien.
What is the risk associated with ProMeris Duo?
X’ inhu r- riskju assoċjat ma ’ ProMeris Duo?
The most common side effects in dogs are sedation (sleepiness), lethargy (a lack of energy), reduced nervous system activity, hyperglycaemia (high blood sugar levels), bradycardia (slow heart rate), and slow, shallow breathing.
L- effetti sekondarji l- iktar komuni huma l- ħedla, letarġija (nuqqas ta ’ enerġija), attività mnaqqsa tas- sistema nervuża, ipergliċemija (livelli għoljin taz- zokkor fid- demm), bradikardija (taħbit tal- qalb mhux mgħaġġel), teħid tan- nifs bil- mod u mhux qawwi.
These usually disappear without treatment within 24 hours.
Is- soltu jgħibu mingħajr it- trattament fi żmien 24 siegħa.
There may also be a change in appearance of the fur (oily appearance and clumping or spiking of hair) at the application site.
Jista ’ jkun hemm ukoll tibdil fl- apparenza tal- pil (apparenza żejtnija jew tagħqid tax- xagħar jew jitla xwiek) fis- sit tal- applikazzjoni.
In rare cases, temporary irritation may occur at the site of application.
F’ każijiet rari, jista ’ jkun hemm irritazzjoni temporanja fis- sit tal- applikazzjoni.
In very rare cases, temporary local hair loss may occur.
F’ każijiet rari ħafna, jista ’ jkun hemm telf temporanju lokali tax- xagħar.
If a dog licks the application area, the dog might salivate considerably for a short period.
Jekk kelb jilgħaq is- sit tal- applikazzjoni, jista ’ jesperjenza tibżiq konsiderevoli għal perjodu ta ’ żmien qasir.
ProMeris Duo must not be used in puppies less than eight weeks old since it has not been sufficiently studied in these animals.
ProMeris Duo ma għandux jintuża fil- ġriewi ta ’ inqas minn tmien ġimgħat minħabba li għadu ma ġiex studjat biżżejjed f’ dawn l- annimali.
As for other products in this group, ProMeris Duo should not be used in sick dogs, dogs that have just recovered from an illness or dogs that are suffering from heat stress.
Bħall- prodotti l- oħra f’ dan il- grupp, ProMeris Duo ma għandux jintuża fil- klieb morda, klieb li għadhom kif irkupraw minn marda jew klieb li qegħdin ibatu minn stress ta ’ sħana.
This medicine is specifically developed for dogs and should not be used in any other animal species.
Din il- mediċina hija żviluppata speċifikament għall - klieb u ma għandhiex tintuża fi speċi oħra ta ’ annimal.
As a precautionary measure, avoid direct contact with the treated dog and do not allow children to play with the treated dog until the application site is dry.
Bħala prekawzjoni, evita l- kuntatt dirett ma ’ kelb ittrattat u tħallix lit- tfal jilgħabu miegħu sakemm jixxotta s- sit tal- applikazzjoni.
Recently treated animals should not be allowed to sleep in the same bed as their owners, especially children.
Annimali ttrattati reċentement ma għandhomx jitħallaw jorqdu fl- istess sodda ma ’ sidhom, partikolarment mat- tfal.
ProMeris Duo contains components that, on very rare occasions, can irritate the airways in some people.
ProMeris Duo fih komponenti li, f’ każijiet rari jistgħu jirritaw l- imnifsejn ta ’ xi nies.
It is recommended that the product is applied in the open air or in a well-ventilated room.
Huwa rakkomandat li l - prodott jiġi applikat fil- beraħ jew f’ kamra b’ ventilazzjoni tajba.
Amitraz is a monoamine oxidase inhibitor (MOAI).
Amitraz huwa inibitur tal- ossidażi monoamina (monoamine oxidase inhibitor - MOAI).
People taking MOAI-containing medicines, such as antidepressants, should take particular care when handling ProMeris Duo.
Persuni li jieħdu mediċini li fihom MOAI, bħal ma huma antidepressivi, għandhom jagħtu attenzjoni partikolari fl- użu ta ’ ProMeris Duo.
Avoid touching the skin with the pipette’ s contents.
Evita li tmiss il- ġilda bil- kontenut tal- pipetta.
Protective gloves are recommended when handling the medicine.
Ingwanti protettivi huma rrakkomandati waqt l - użu tal- mediċina.
Wash the skin and rinse eyes with water, if accidental exposure occurs.
F’ każ ta ’ esponiment bi żball, aħsel il- ġilda u laħlaħ l- għajnejn bl- ilma.
Do not smoke, eat or drink when applying ProMeris Duo.
Tpejjipx, tikolx u tixrobs meta tkun qed tapplika ProMeris Duo.
ProMeris Duo should not enter surface water, as this may be harmful for fish and other aquatic organisms.
Paġna 2/ 3 ©EMEA 2009 ProMeris Duo m’ għandux jidħol fl- ilma f’ wiċċ l- art minħabba li jista ’ jkun perikoluż għall- ħut u għall- organiżmi oħra tal- ilma.
Why has ProMeris Duo been approved?
Għaliex ġie approvat ProMeris Duo?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProMeris Duo exceed the risks for the treatment and prevention of flea and tick infestations, and the treatment of demodicosis and lice infestation in dogs.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu Veterinarju (CVMP) ikkonkluda li l- benefiċċji ta ’ ProMeris Duo huma akbar mir- riskji tiegħu fit- trattament u l- prevenzjoni ta ’ impestazzjonijiet ta ’ briegħed u qurdien, u fit- trattament tad- demodiċożi u imprestazzjoni tal - qamel fil- klieb.
The Committee recommended that ProMeris Duo be given a marketing authorisation.
Il- Kumitat irrakkomanda li ProMeris Duo jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Other information about ProMeris Duo:
Tagħrif ieħor dwar ProMeris Duo:
The European Commission granted a marketing authorisation valid throughout the European Union for ProMeris Duo to Fort Dodge Animal Health on 19 December 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea għal ProMeris Duo lil Fort Dodge Animal Health fid- 19 ta ’ Diċembru 2006.
Information on the prescription status of this product may be found on the label/ outer package.
L - informazzjoni dwar l- istat tal- preskrizzjoni ta ’ dan il- prodott jista ’ jiġi kkonsultat fuq it - tikketta jew fuq il- qoxra tal- pakkett.
This summary was last updated on 19 February 2009.
Dan is- sommarju ġie aġġornat l- aħħar fid- 19 ta ’ Frar 2009.
Page 2/ 2 ©EMEA 2009
Paġna 3/ 3 ©EMEA 2009
ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/ large sized dogs ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs ProMeris Duo 999 mg + 999mg Spot-on for extra large dogs
ProMeris Duo 100. 5 mg + 100. 5 mg għall- Użu Lokalizzat għall- klieb żgħar ProMeris Duo 199. 5 mg + 199. 5 mg għall- Użu Lokalizzat għall- klieb ta ’ daqs medju ProMeris Duo 499. 5 mg + 499. 5 mg għall- Użu Lokalizzat għall- klieb ta ’ daqs medju/ kbir ProMeris Duo 799. 5 mg + 799. 5 mg għall- Użu Lokalizzat għall- klieb kbar ProMeris Duo 999 mg + 999mg għall- Użu Lokalizzat għall- klieb kbar ħafna
Active substances Each ml contains 150 mg metaflumizone and 150 mg amitraz.
Kull ml fih 150 mg metaflumizone u 150 mg amitraz.
Each unit dose (pipette) of ProMeris Duo delivers:
Kull unità ta ’ doża (pipetta) ta ’ ProMeris Duo tagħti:
ProMeris Duo Spot-on for Dogs
ProMeris Duo għall- Użu Lokalizzat għall- klieb Ghall- Klieb Żgħar (≤ 5 kg)
Volume (ml)
Volum (ml) 0. 67
Metaflumizone (mg)
Metaflumizone (mg) 100. 5
Amitraz (mg)
Amitraz (mg) 100. 5
for Small Dogs (≤ 5 kg) for Medium Sized Dogs - (5.1 – 10.0 kg) for Medium/ Large Sized Dogs (10.1 – 25.0 kg) for Large Dogs (25.1 – 40.0 kg) for Extra Large Dogs (40.1 – 50.0 kg)
Ghall- Klieb ta ’ daqs Medju (5. 1 – 10. 0 kg) Ghall- Klieb ta ’ daqs Medju/ Kbir (10. 1 – 25. 0 kg) Ghall- Klieb Kbar (25. 1 – 40. 0 kg) Ghall- Klieb Kbar Ħafna (40. 1 – 50. 0 kg)
0.67 1.33 3.33 5.33 6.66
1. 33 3. 33 5. 33 6. 66
100.5 199.5 499.5 799.5 999
199. 5 499. 5 799. 5 999
Spot-on solution A clear, yellow to amber solution
Soluzzjoni għall- Użu Lokalizzat Soluzzjoni ċara, safra sa amber
Dogs over 8 weeks of age
Klieb b’ età ’ l fuq minn 8 ġimgħat
For the treatment and prevention of infestations by fleas (Ctenocephalides canis and C. felis), and ticks (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus and Dermacentor variabilis), and treatment of demodicosis (caused by Demodex spp.) and lice (Trichodectes canis) in dogs.
Għall- kura u l- prevenzjoni ta ’ infestazzjonijiet minn briegħed (Ctenocephalides canis u C. felis) u qurdien (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus u Dermacentor variabilis), u għall- kura ta ’ demodikosi (ikkawżata minn Demodex spp.) u tal- qamel (Trichodectes canis) fil- klieb.
The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).
Il- prodott mediċinali veterinarju jista ’ jintuża bħala parti minn strateġija ta ’ kura għal dermatite allerġika tal- bergħud (FAD).
Do not administer to puppies under 8 weeks of age.
Tużax fi ġriewi taħt l- età ta ’ 8 ġimgħat.
Do not administer to cats Do not administer to sick or debilitated dogs or dogs suffering from heat stress.
Tużax fil- qtates Tużax fi klieb morda jew dgħajfa jew klieb li qed isofru minn stress għas- sħana.
2/ 39 4.4 Special warnings
2/ 43 4. 4 Twissijiet speċjali
Avoid contact with the eyes of the dog and avoid oral ingestion by the dog.
Evita kuntatt ma ’ l- għajnejn tal- kelb u evita inġestjoni orali mill- kelb.
The veterinary medicinal product remains effective if the animal becomes wet.
Il- prodott mediċinali veterinarju jibqa ’ effettiv jekk l- annimal jixxarrab.
However, prolonged, intense exposure to water should be avoided.
Iżda, espożizzjoni fit- tul u intensa għall- ilma għandha tiġi evitata.
Dogs should be prevented from accessing streams and rivers for the 24-hour period following treatment.
Il- klieb m’ għandhomx jitħallew imorru f’ nixxigħat u xmajjar għal perjodu ta ’ 24 siegħa wara l- kura.
In cases of frequent water exposure the duration of activity may be reduced.
F’ każ ta ’ espożizzjoni frekwenti għall- ilma, it- tul ta ’ żmien li jdum attiv jista ’ jonqos.
In these cases do not treat more frequently than once a fortnight.
F’ dawn il- każijiet tikkurax b’ mod aktar frekwenti minn darba kull ġimagħtejn.
If the dog requires shampooing, it is better to do so before applying the veterinary medicinal product.
Jekk il- kelb jinħtieġ li jinħasel b’ xampù, dan aħjar isir qabel ma tapplika l- prodott mediċinali veterinarju.
For optimum control of flea problems in a multi-pet household, all pets in the household should be treated with a suitable insecticide.
Għall- kontroll ottimali tal- problemi tal- briegħed f’ dar fejn hemm aktar minn annimal wieħed, l - annimali kollha fid- dar għandhom jiġu trattati b’ insettiċida xieraq.
In addition it is recommended to treat the environment with a suitable insecticide.
Barra minn hekk huwa rakkomandat li l- ambjent jiġi ttrattat b’ insettiċida xieraq.
For use only under the supervision of a veterinary surgeon.
Għall- użu taħt is- superviżjoni ta ’ kirurgu veterinarju biss.
This veterinary medicinal product is for spot-on application only.
Dan il- prodott mediċinali veterinarju huwa għall- użu lokalizzat biss.
Do not administer orally or via any other route.
Tagħtix mill- ħalq jew minn xi rotta oħra.
It is important to apply the dose to an area where the animal cannot lick it off and to make sure that animals do not lick each other following treatment.
Huwa importanti li tapplika d- doża f’ post fejn l- annimal ma jistax jilgħaqu u jneħħih u li tiżgura li l - annimali ma jilgħaqux lil xulxin wara l- kura.
Care should be taken to ensure that the content of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/ or other animals.
Għandha tittieħed attenzjoni sabiex jiġi żgurat li l- kontenut tal- pipetta jew id- doża applikata ma tiġix f’ kuntatt ma ’ l- għajnejn jew mal- ħalq tar- reċipjent u/ jew ta ’ annimali oħra.
This product should not be administered by children.
Il- pipetti maħżuna għandhom jinżammu fil- pakkett tal - folja intatt. Dan il- prodott m’ għandux jingħata mit- tfal.
This product contains amitraz, which can lead to adverse neurological effects in humans and especially in children.
Dan il prodott fih amitraz, li jista ’ jwassal għall- effetti avversi newroloġiċi fil- bnedmin u speċjalment fit- tfal.
Children should not have access to used pipettes.
It- tfal m’ għandhomx ikollhom aċċess għall- pipetti wżati.
Used pipettes should be disposed of immediately.
Pipetti wżati għandhom jintremew minnufiħ.
Amitraz is a monoamine oxidase inhibitor (MOAI); therefore, people taking MOAI-containing medication should take particular care when handling this product.
Amitraz huwa inibitur ta ’ monoamine oxidase (MOAI); għalhekk, persuni li qed jieħdu mediċini li fihom MOAI għandhom jimmaniġġjaw dan il- prodott b’ attenzjoni speċjali.
Avoid direct contact with treated animals until the application site is dry.
Evita kuntatt dirett ma ’ annimali trattati sakemm il- post tal- applikazzjoni jinxef.
Children should not be allowed to have contact with treated animals until the application site is dry.
It- tfal m’ għandhomx jitħallew li jkollhom kuntatt ma ’ annimali trattati qabel ma l- post tal- applikazzjoni jinxef.
Recently treated animals should not be allowed to sleep with the owners, especially children.
Annimali li għadhom kif ġew ikkurati m’ għandhomx jitħallew jorqdu mas- sidien tagħhom, speċjalment tfal.
ProMeris Duo contains components that, on very rare occasions, can cause respiratory irritation in certain people.
ProMeris Duo fih komponenti li f’ okkażjonijiet rari ħafna jistgħu jikkawżaw irritazzjoni respiratorja f’ xi individwi.
To minimise the potential for inhalation, it is recommended that the product is applied in open air or in well ventilated rooms.
Biex jitnaqqas il- potenzjal ta ’ teħid man- nifs, huwa rrakkomandat li l- applikazzjoni tal - prodott issir fil- miftuħ jew f’ postijiet b’ ċirkolazzjoni ta ’ arja tajba.
This product may cause skin sensitisation and allergic reactions in humans.
Dan il- prodott jista ’ jikkawża sensibilizzazzjoni tal- ġilda u reazzjonijiet allerġiċi fil- bnedmin.
Dermal exposure to the product should therefore be avoided.
Għalhekk, espożizzjoni tal- ġilda għall- prodott għandu jiġi evitat.
The use of protective gloves while handling the product is recommended.
Huwa rakkomandat li waqt l - immaniġġjar tal- prodott jintużaw ingwanti ta ’ protezzjoni.
3/ 39 If ill effects are noted following exposure to the product, seek immediate medical assistance, and show the product packaging to the physician.
Jekk jiġu nnutati effetti ħżiena wara espożizzjoni għall- prodott, fittex assistenza medika minnufiħ, u uri l- pakkett ta ’ barra tal- prodott lit- tabib.
Wash hands thoroughly after use.
3/ 43 Aħsel l- idejn sew wara l- użu.
In case of accidental spillage onto skin, wash off immediately with soap and water.
F’ każ ta ’ tixrid aċċidentali fuq il- ġilda, aħsel minnufiħ bis- sapun u bl - ilma.
This product may cause mild eye irritation.
Dan il- prodott jista ’ jikkawża irritazzjoni ħafifa fl- għajnejn.
If the product accidentally gets into eyes, they should be thoroughly flushed with water.
Jekk bi żball il- prodott jidħol fl- għajnejn, dawn għandhom jitlaħalħu sew bl- ilma.
Do not smoke, drink or eat while handling the product.
Tpejjipx, tixrobx jew tiekolx waqt li qed timmaniġġja l- prodott.
Known side-effects of amitraz and metabolites, such as sedation, lethargy, CNS depression, hyperglycaemia, bradycardia and slow, shallow breathing may be observed in a small number of animals.
F’ numru żgħir ta ’ annimali jistgħu jiġu osservati effetti mhux mixtieqa, magħrufa ta ’ amitraz u l - metaboliti, bħal sedazzjoni, letarġija, depressjoni tas- CNS, ipergliċemija, bradikarjda, u nifs baxx u bil- mod.
Most of these signs are due to alpha-2-adreno-receptor agonist effects.
Il- biċċa l- kbira ta ’ dawn is- sinjali huma minħabba l- effetti agonisti tar- riċettur alfa- 2- adreno.
Signs are usually transitory and generally resolved without treatment within 24 hours.
Is- sinjali ħafna drabi huma transitorji u ġeneralment jgħaddu mingħajr kura f’ temp ta ’ 24 siegħa.
If symptoms are severe or persist the alpha-2-adreno-receptor antagonist atipamezole hydrochloride may be used at a dose of 0.2 mg/ kg bodyweight by intramuscular injection to reverse these side-effects.
Jekk is- sintomi huma severi jew jippersistu jista ’ jintuża l- antagonist tar- riċettur alpha- 2- adreno atipamezole hydrochloride f’ doża ta ’ 0. 2 mg/ kg piż tal- ġisem permeżż ta ’ injezzjoni ġol- muskoli biex ireġġa ’ lura dawn l- effetti mhux mixtieqa.
Hypersalivation may occur if the animal licks the application site immediately after treatment.
Tista ’ sseħħ ipersalivazzjoni jekk l- annimal jilaq il- post ta ’ l- applikazzjoni eżatt wara l- kura.
This is not a sign of intoxication and disappears within minutes without treatment.
Dan mhux sinjal ta ’ intossikazzjoni u jgħaddi wara ftit minuti mingħajr kura.
Correct application will minimise licking of the application site.
Applikazzjoni korretta tnaqqas li l- annimal jilgħaq il- post ta ’ l- applikazzjoni.
The application of the veterinary medicinal product may produce a local, temporary oily appearance and clumping or spiking of the hair at the application site.
L- applikazzjoni tal- prodott mediċinali veterinarju tista ’ tipproduċi dehra temporanjament żejtnija u tagħqid jew ippuntar tax- xahar fil- post ta ’ applikazzjoni.
A dry residue may also be observed.
Jista ’ jkun osservat ukoll fdal niexef.
This is normal and will generally resolve within a few days after administration, though may persist longer on rare occasions.
Dan huwa normali u ġeneralment jgħaddi fi ftit ġranet wara l- applikazzjoni, għalkemm f’ każijiet rari, jista ’ jippersisti għal aktar fit- tul.
These changes do not affect the safety or efficacy of the veterinary medicinal product.
Dawn il- bidliet ma jaffettwawx is- sigurtà u l- effikaċja tal- prodott mediċinali veterinarju.
In rare cases, transient irritation may occur at the site of product application.
F’ każijiet rari, tista ’ sseħħ irritazzjoni temporanja fis- sit ta ’ l- applikazzjoni tal- prodott.
In very rare cases temporary local hair loss may occur.
F’ każijiet rari ħafna jista ’ jkun hemm telf temporanju lokali tal- pil.
Can be used during pregnancy and lactation.
Jista 'jintuza waqt it- tqala u fi zmien il- halib
Treatment with other products containing amitraz is not recommended whilst the dog is being treated with ProMeris Duo Spot-On for Dogs.
Kura bi prodotti oħra li fihom amitraz mhux rakkomandat waqt li l- kelb qed jiġi kkurat b’ ProMeris Duo għall- Użu Lokalizzat għall- Klieb.
The recommended minimum dose is 20 mg/ kg bodyweight for each of metaflumizone and amitraz, equivalent to 0.133ml/ kg bodyweight.
Id- doża minima rakkomandata hija ta ’ 20 mg/ kg piż tal- ġisem għal metaflumizone kif ukoll għal amitraz, ekwivalent għal 0. 133 ml/ kg piż tal- ġisem.
The following table defines the size of pipette to be used according to the weight of the dog.
It- tabella li ġejja tiddefinixxi id- daqs tal- pipetta li għandha tintuża skond il- piż tal- kelb.
Weight Range of
4/ 43 Firxa ta ’ Piż tal- Kelb
Pipette size to be used
Daqs tal- pipetta li għandha tintuża
≤ 5 5.1 – 10.0 10.1 – 25.0 25.1 – 40.0 40.1 – 50.0
5. 1 – 10. 0 10. 1 – 25. 0 25. 1 – 40. 0 40. 1 – 50. 0
ProMeris Duo ProMeris Duo ProMeris Duo ProMeris Duo ProMeris Duo
ProMeris ProMeris ProMeris ProMeris
for Small Dogs Medium Sized Dogs for Medium/ Large Sized Dogs for Large Dogs for Extra Large Dogs
Duo għall- Klieb ta ’ daqs Medju Duo għall- Klieb ta ’ daqs Medju/ Kbir Duo għall- Klieb Kbar Duo għall- Klieb Kbar Ħafna
33 5.33 6.66
1. 33 3. 33 5. 33 6. 66
For dogs more than 50 kg, use a combination of two pipettes that most closely matches the body weight.
Għall- klieb akbar minn 50 kg, uża kombinazzjoni ta ’ żewġ pipetti li l- aktar jaqblu mal- piż tal- ġisem.
Method of administration:
Metodu ta ’ amministrazzjoni:
For external use only.
Għall- użu minn barra biss.
Spot-on use.
Għall- Użu Lokalizzat.
Remove the pipette from the package.
Neħħi l- pipetta mill- pakkett.
Hold the pipette upright, bend the tip of the pipette to break the tip along the scored line.
Żomm il- pipetta wieqfa, għawweġ il- ponta biex taqsam il- ponta tul il - linja mmarkata.
The top of the tip will fold back against the pipette.
It- tarf ta ’ fuq tal- ponta tintlewa lura ma ’ wara tal- pipetta.
Part the hair and apply the contents of the pipette to a single spot on the skin of the dog at the base of the skull.
Ferraq il- pil u applika il- kontenut tal- pipetta f’ post wieħed fuq il- ġilda tal- kelb fil- bażi tar- ras.
Place the tip of the pipette on the skin and squeeze the pipette to empty the entire contents.
Poġġi l- ponta tal- pipetta fuq il- ġilda u għafas il- pipetta sabiex tbattal il- kontenut kollu tagħha.
Do not apply the veterinary medicinal product to the surface of the dog’ s hair coat.
Tapplikax il- prodott mediċinali veterinarju fuq il- wiċċ tal- pil tal- kelb.
Treatment schedule:
Programm ta ’ kura:
For optimal control of flea and/ or tick infestation the product should be administered at monthly intervals throughout the flea and/ or tick season, or the treatment schedule can be based on the local epidemiological situation.
Għall- kontroll ottimali ta ’ infestazzjoni tal- briegħed u/ jew qurdien il- prodott għandu jingħata f’ intervalli ta ’ xahar matul l- istaġun tal- briegħed u/ jew qurdien, jew il- programm ta ’ kura jista ’ jiġi bbażat fuq is- sitwazzjoni epidemjoloġika lokali.
Kills most ticks within 48 hours.
Joqtol il- biċċa l- kbira tal- qurdien fi żmien 48 siegħa.
For treatment of biting lice a single dose should be sufficient.
Għall- kura ta ’ qamel li jigdem doża waħda għandha tkun biżżejjed.
For treatment of demodicosis, the product should be administered at monthly intervals until clinical signs resolve.
Il- biċċa l- kbira tal- qamel imut fi żmien 7t ijiem. Għall- kura ta ’ demodikosi, l- prodott għandu jiġi amministrat f’ intervalli ta ’ kull xahar sakemm is- sinjali kliniċi jgħaddu.
Where possible, treatment should not be discontinued until skin scrapings are negative on at least two monthly occasions.
Fejn possibbli, il- kura m’ għandhiex titwaqqaf qabel kampjuni tal - ġilda jkunu negattivi f’ minn ta ’ l- inqas żewġ okkażjonijiet f’ xahar.
As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Peress li demodikosi hija marda kkawżata minn diversi fatturi, fejn possibbli, huwa rrakkomandat li tikkura wkoll kif jixraq, xi marda li hemm preżenti.
The veterinary medicinal product will prevent flea infestation for up to 6 weeks and tick infestation for 4 weeks following a single administration.
Il- prodott mediċinali veterinarju iwaqqaf l- infestazzjoni mill- briegħed sa 6 ġimgħat u l- infestazzjoni tal- qurdien għal 4 ġimgħat wara amministrazzjoni waħda.
5/ 39 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
5/ 43 4. 10 Doża eċċessiva (sintomi, proċeduri ta ’ emerġenza, antidoti), jekk ikun hemm bżonn
No adverse effects were observed in healthy dogs and puppies aged 8 weeks and older treated 7 times at two-week intervals with 3-5 times the recommended dose.
l- ebda effetti avversi ma kienu osservati fi klieb b’ saħħithom u ġriewi b’ età ta ’ 8 ġimgħat jew aktar trattati 7 darbiet f’ intervalli ta ’ ġimagħtejn b’ 3- 5 darbiet id- doża rakkomandata.
The risk of experiencing adverse effects may however increase when overdosing, so animals should always be treated with the correct pipette size according to body weight.
Iżda, ir- riskju li jinħassu effetti avversi jista ’ jiżdied meta tingħata doża eċċessiva, għalhekk l- annimali għandhom dejjem jiġu trattati bid- daqs tal- pipetta s- sewwa skond il- piż tal- ġisem.
Known side-effects of amitraz and metabolites are sedation, lethargy, CNS depression, hyperglycaemia, bradycardia and slow, shallow breathing.
Effetti mhux mixtieqa, magħrufa ta ’ amitraz u l- metaboliti, huma sedazzjoni, letarġija, depressjoni tas - CNS, ipergliċemija, bradikarjda, u nifs baxx u bil- mod.
Most of these signs are due to alpha-2- adreno-receptor agonist effects.
Il- biċċa l- kbira ta ’ dawn is- sinjali huma minħabba l- effetti agonisti tar- riċettur alfa- 2- adreno.
If symptoms are severe or persist the alpha-2-adreno-receptor antagonist atipamezole hydrochloride may be used at a dose of 0.2 mg/ kg bodyweight by intramuscular injection to reverse these side- effects.
Jekk is- sintomi huma severi jew jippersistu jista ’ jintuża l- antagonist tar- riċettur alpha- 2- adreno, atipamezole hydrochloride f’ doża ta ’ 0. 2 mg/ kg piż tal- ġisem permeżż ta ’ injezzjoni ġol- muskoli biex ireġġa ’ lura dawn l- effetti mhux mixtieqa.
ATC Vet Code QP 53AD51
Kodici ATĊ veterinarja QP 53AD51
Metaflumizone is an insecticide belonging to the semicarbazone group of compounds.
Metaflumizone huwa insettiċida li jagħmel parti mill- grupp ta ’ sustanzi semicarbazone.
Metaflumizone is a sodium channel antagonist and disrupts nerve function resulting in paralysis and death of insects.
Metaflumizone huwa antagonist tal- kanal tas- sodju u jtellef il- funzjoni tan- nerv u b’ hekk iwassal għall- paraliżi u l- mewt ta ’ l- insetti.
Amitraz is a formamidine acaricide.
Amitraz huwa akariċida formamidine..
It acts at octopamine receptor sites in ectoparasites giving rise to increased nervous activity and death of insects.
Huwa jaħdem fis- siti tar- riċettur ta ’ octopamine f’ ektoparassiti u jwassal għal żieda fl- attività nervuża u l- mewt ta ’ l- insetti.
Metaflumizone and amitraz are combined in the final formulation to provide a broad spectrum of activity against both fleas and ticks, respectively, due to non-systemic exposure of the parasites on the skin and hair.
Metaflumizone u amitraz huma kkombinati fil- formulazzjoni finali biex jipprovdu firxa wiesa ta ’ attività kontra kemm il- briegħed kif ukoll il- qurdien, rispettivament, minħabba espożizzjoni mhux sistemika tal- parassiti fuq il- ġilda u l- pil.
Maximum efficacy is achieved within 48 hours.
L- effikaċja massima tintlaħaq f’ 48 siegħa.
After topical administration at a single site at the base of the skull, both metaflumizone and amitraz were rapidly distributed throughout the surface of the skin.
Wara amministrazzjoni topika f’ sit wieħed fil- bażi tar- ras, kemm metaflumizone kif ukoll amitraz kienu distribwiti malajr mas- superfiċje kollha tal- ġilda.
Maximum concentrations in the hair were generally reached between 2 to 7 days post treatment and gradually declined through 56 days post treatment.
Konċentrazzjonijiet massimi fil- pil intlaħqu ġeneralment f’ jumejn sa sebat ijiem wara l- kura u naqsu b’ mod gradwali tul 56 ġurnata wara l- kura.
Both components were still measurable in the hair 56 days following treatment.
Iż- żewġ komponenti kienu għad jistgħu jiġu mkejla fil- pil 56 ġurnata wara l- kura.
After topical administration at a single site at the base of the skull, both metaflumizone and amitraz levels in plasma were too low to allow the calculation of standard pharmacokinetic parameters.
Wara amministrazzjoni topika f’ sit wieħed fil- bażi tar- ras, il- livelli fil- plażma ta ’ metaflumizone u amitraz kienu baxxi wisq biex tkun tista ’ ssir kalkulazzjoni tal- parametri stàndard tal- farmakokinetika.
5.3 Environmental properties
5. 3 Propjetajiet ambjentali, jekk applikabbli
6/ 39 6.
Ara sezzjoni 6. 6
Shelf life of the veterinary medicinal product as package for sale:
Żmien li l- prodott mediċinali veterinarju jista ’ jinżamm fuq l- ixkaffa ippakkjat għall- bejgħ:
24 months.
24 il- xahar.
Do not store above 25 °C
Taħżinx f' temperaturi ogħla minn 25 °C
The veterinary medicinal product is packaged in individual-dose transparent plastic pipettes over packed in an aluminium foil package.
Il- prodott mediċinali veterinarju jiġi ppakkjat f’ dożi individwali f’ pipetti tal- plastik trasparenti li huma ippakkjati mill- ġdid f’ pakkett tal- fojl ta ’ l- aluminju.
It is supplied in units of 3 pipettes per cardboard card and one or two cards per cardboard box.
Huwa pprovdut f’ unitajiet ta ’ 3 pipetti kull pakkett tal- kartun u kull kaxxa tal- kartun fiha pakkett tal- kartun wieħed jew tnejn.
All blisters in a box are the same size.
F’ kaxxa, kull folja hija ta ’ l- istess daqs.
Box of 1 or 2 blister card of 3 x 0.67 ml pipettes Box of 1 or 2 blister card of 3 x 1.33 ml pipette Box of 1 or 2 blister card of 3 x 3.33 ml pipettes Box of 1 or 2 blister card of 3 x 5.33 ml pipettes Box of 1 or 2 blister card of 3 x 6.66 ml pipettes
Kaxxa ta ’ 1 jew 2 pakketti f’ folja ta ’ 3 x pipetti ta ’ 0. 67 ml Kaxxa ta ’ 1 jew 2 pakketti f’ folja ta ’ 3 x pipetti ta ’ 1. 33 ml Kaxxa ta ’ 1 jew 2 pakketti f’ folja ta ’ 3 x pipetti ta ’ 3. 33 ml Kaxxa ta ’ 1 jew 2 pakketti f’ folja ta ’ 3 x pipetti ta ’ 5. 33 ml Kaxxa ta ’ 1 jew 2 pakketti f’ folja ta ’ 3 x pipetti ta ’ 6. 66 ml
Not all pack sizes may be marketed.
Jista ’ jkun li mhux id- daqsijiet tal- pakketti kollha jitpoġġew fis- suq.
The veterinary medicinal product should not enter watercourses, as this may be dangerous for fish and other aquatic organisms.
Il- prodott mediċinali veterinarju ma għandu qatt jitħalla jmur man- nixxigħat tal- ilma minħabba li jista ’ jkun ta 'periklu għall- ħut jew ħlejqiet oħra akwatici.
Carefully dispose of used pipettes immediately after use.
Armi b’ kawtela pipetti wżati mmedjatament wara l - użu.
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp, The Netherlands
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 1381 CP Weesp, L- Olanda
7/ 39 8.
7/ 43 8.
19/ 12/ 2006
19 ta ’ Diċembru 2006
8/ 39 ANNEX II
8/ 43 ANNESS II
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- HRUĠ TAL- LOTT
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
SID TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL - HRUĠ TAL- LOTT
Via Franco Gorgone 95030 Catania Italy
Via Franco Gorgone 95030 Catania L- Italja
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Is- sid ta ’ din l- awtorizzazzjoni tal- kummerċ għandu jinforma l- Kummissjoni Ewropeja dwar il - pjanijiet ta ’ kummerċ għal dan il- prodott mediċinali awtorizzat minn din id- deċiżjoni.
10/ 39 ANNEX III
10/ 43 ANNESS III
12/ 39 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
12/ 43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Carton box for 1 blister card - Carton box for 2 blister cards
Kaxxa tal- kartun b’ pakket f’ folja – Kaxxa tal- kartun b’ 2 pakketti f’ folja
ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs {≤ to 5 kg}
ProMeris Duo 100. 5 mg + 100. 5 mg għall- użu lokalizzat għall- klieb żgħar {≤ to 5 kg}
Each 0.67 ml pipette delivers:
Kull pipetta ta ’ 0. 67 ml tagħti:
100.5 mg metaflumizone and 100.5 mg amitraz
100. 5 mg metaflumizone u 100. 5 mg amitraz
Spot-on solution
Soluzzjoni għall- użu lokalizzat
Box of 1 blister card of 3 x 0.67 ml pipettes Box of 2 blister cards of 3 x 0.67 ml pipettes
Kaxxa b’ pakkett f’ folja ta ’ 3 x pipetti ta ’ 0. 67 ml Kaxxa b’ 2 pakketti f’ folja ta ’ 3 x pipetti ta ’ 0. 67 ml
For dogs over 8 weeks of age.
Għall- klieb b’ età ’ l fuq minn 8 ġimgħat.
For the treatment and prevention of infestations by fleas and ticks, and treatment of demodicosis and lice.
Għall- kura u prevenzjoni ta ’ infestazzjonijiet minn briegħed u qurdien, u għall- kura ta ’ demodikosi u tal- qamel.
For external use only.
Għal użu minn barra biss.
Do not administer to puppies under 8 weeks of age.
Tagħtix lill- ġriewi taħt l- età ta ’ 8 ġimgħat.
Children should not have contact with the product or with animals during treatment.
It- tfal m’ għandhomx ikollhom kuntatt mal- prodott jew ma ’ l- annimali waqt il- kura.
For further information see package leaflet.
Għall- aktar tagħrif ara l- fuljett ta 'tagħrif fil- pakkett.
Do not store above 25°C
Taħżinx f' temperatura l- fuq minn 25°C.
Dispose of waste material in accordance with local requirements.
Armi l- materjal li ma ntużax skond kif titlob il- liġi tal- pajjiż.
Marketing authorisation holder Fort Dodge Animal Health C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Is- sid ta ’ l- awtorizzazzjoni tal- kummerċ Fort Dodge Animal Health C. J. van Houtenlaan 36 1381 CP Weesp L- Olanda
EU/ 2/ 06/ 065/ 001 – 1 blister card of 3 pipettes of 0.67ml EU/ 2/ 06/ 065/ 002 – 2 blister cards of 3 pipettes of 0.67ml
EU/ 2/ 06/ 065/ 001 – Pakkett f’ folja ta ’ 3 pipetti ta ’ 0. 67 ml EU/ 2/ 06/ 065/ 002 – Żewġ pakketti f’ folja ta ’ 3 pipetti ta ’ 0. 67 ml
14/ 39 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
15/ 43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs {5.1 – 10.0 kg}
ProMeris Duo 199. 5 mg + 199. 5 mg għall- użu lokalizzat għall- klieb ta’ daqs medju {5. 1 – 10. 0 kg}
Each 1.33 ml pipette delivers:
Kull pipetta ta ’ 1. 33 ml tagħti:
199.5 mg metaflumizone and 199.5 mg amitraz
199. 5 mg metaflumizone u 199. 5 mg amitraz
Box of 1 blister card of 3 x 1.33 ml pipettes Box of 2 blister cards of 3 x 1.33 ml pipettes
Kaxxa b’ pakkett f’ folja ta ’ 3 x pipetti ta ’ 1. 33 ml Kaxxa b’ 2 pakketti f’ folja ta ’ 3 x pipetti ta ’ 1. 33 ml
9.
16/ 43 9.
EU/ 2/ 06/ 065/ 003 – 1 blister card of 3 pipettes of 1.33ml EU/ 2/ 06/ 065/ 004 – 2 blister cards of 3 pipettes of 1.33ml
EU/ 2/ 06/ 065/ 003 – Pakkett f’ folja ta ’ 3 pipetti ta ’ 1. 33 ml EU/ 2/ 06/ 065/ 004 – Żewġ pakketti f’ folja ta ’ 3 pipetti ta ’ 1. 33 ml
17.
17/ 43 17.
16/ 39 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
18/ 43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA 'BARRA
Carton box for 1 blister card - Carton box for 2 blister cards
Kaxxa tal- kartun b’ pakkett f’ folja – Kaxxa tal- kartun b’ 2 pakketti f’ folja
ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/ large sized dogs {10.1 – 25.0 kg}
ProMeris Duo 499. 5 mg + 499. 5 mg għall- użu lokalizzat għall- klieb ta’ daqs medju/ kbir {10. 1 – 25. 0 kg}
Each 3.33 ml pipette delivers:
Kull pipetta ta ’ 3. 33 ml tagħti: