qanastek/EMEA-V3 huggingface dataset:
To the physician This product contains mineral oil.
Dan il- prodott fih żejt minerali.
Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Attenzjoni kiruġika, esperta, u FIL- PRONT, hi meħtieġa u li tista ’ tinkludi inċiżjoni u irrigazzjoni bikrija tal- parti injettata, speċjalment jekk ikun hemm involviment tal- laħam tat- tarf tas - saba ’ jew l- għerq.
No information is available on the compatibility of this vaccine with any other.
Ma hemm l- ebda informazzjoni dwar is- sigurtà u l- effikaċja mill- użu konkorrenti ta ’ dan il- vaċċin ma ’ xi ieħor.
Therefore the safety and efficacy of this product when used with any other (either used on the same day or at different times) has not been demonstrated.
Għaldaqstant, huwa rakkomandat li l- ebda vaċċini oħra m’ għandhom jiġu amministrati fi żmien 14- il jum qabel jew wara t- tilqima bil- prodott.
Following the administration of a double dose in chickens and ducks, no adverse reactions other than those described in section 6 have been observed.
Wara l- amministrazzjoni ta ’ doża doppja fit- tiġieġ u l- papri, l- ebda reazzjonijiet avversi għajr dawk deskritti f’ sezzjoni 6 ma ġew osservati.
The vaccine is presented in boxes of 1 or 10 bottles of 500 ml.
Il- vaċċin jiġi f’ kaxxi ta ’ flixkun wieħed jew 10 fliexken ta ’ 500 ml.
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Avian Influenza.
L- użu ta ’ dan il- prodott veterinarju mediċinali huwa permess biss taħt kundizzjonijiet partikolari stabbiliti mil- leġiżlazzjoni tal- Komunità Ewropea fuq il- kontroll ta ’ l- Influwenza Avjana.
Prac-tic 56.25 mg Spot-on solution for very small dogs Prac-tic 137.5 mg Spot-on solution for small dogs Prac-tic 275 mg Spot-on solution for medium dogs Prac-tic 625 mg Spot-on solution for large dogs
PRAC- TIC 56. 25 mg soluzzjoni spot- on għall- klieb żgħar ħafna PRAC- TIC 137. 5 mg soluzzjoni spot- on għall- klieb żgħar PRAC- TIC 275 mg soluzzjoni spot- on għall- klieb medji PRAC- TIC 625 mg soluzzjoni spot- on għall- klieb kbar
Each ml contains 125 mg pyriprole.
Kull ml fih 125 mg pyriprole.
Each pipette of Prac-tic delivers the following:
Kull pipetta ta 'PRAC- TIC tagħti dan li ġej:
Unit dose
Doża unitarja
Prac-tic for very small dogs Prac-tic for small dogs Prac-tic for medium dogs Prac-tic for large dogs
PRAC- TIC għall- klieb żgħar ħafna PRAC- TIC għall- klieb żgħar PRAC- TIC għall- klieb medji PRAC- TIC għall- klieb kbar
0.1% Butylhydroxytoluene (E321)
0. 1% Butylhydroxytoluene (E321)
Colourless to yellow, clear spot-on solution
Mingħajr kulur għall- kulur li jkanġi fl- isfar, soluzzjoni spot- on ċara
Treatment and prevention of flea infestation (Ctenocephalides canis and C. felis) in dogs.
It- trattament u l- prevenzjoni ta ’ infestazzjoniiet bil- briegħed (Ctenocephalides canis u C. felis) fi klieb.
Insecticidal efficacy duration against new infestations with fleas persists for a minimum of 4 weeks.
Effikaċja insettiċidjali kontra infestazzjonijiet ġodda bil- briegħed tippersisti għall- perijodu minimu ta '4 ġimgħat.
The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
Il- prodott mediċinali veterinarju jista ’ jintuża bħala parti minn strateġija tat- trattament għall - kontroll tad- Dermatitè Allerġika mill- Briegħed (FAD).
Treatment and prevention of tick infestation (Ixodes ricinus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor reticulatus, Dermacentor variabilis, Amblyomma americanum) in dogs.
It- trattament u l- prevenzjoni ta ’ infestazzjonijiet bil- qurdien (Ixodes ricinus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor reticulatus, Dermacentor variabilis, Amblyomma americanum) fil- klieb.
The veterinary medicinal product has persistent acaricidal efficacy duration of 4 weeks against ticks.
Il- prodott mediċinali veterinarju għandu effikaċja akriċidali persistenti kontra l- qurdien għal 4 ġimgħat.
Do not use in dogs less than 8 weeks of age or with a body weight of less than 2 kg.
Tużax fi klieb li għandhom inqas minn 8 ġimgħat t' età jew b' piż korporali ta 'inqas minn 2 kg.
Do not use in case of known hypersensitivity to phenylpyrazole class compounds or any of the excipients.
Tużax f' każijiet ta 'sensittività eċċessiva magħrufa għas- sustanzi tal- klassi ta' phenylpyrazole jew għal xi sustanza oħra mhux attiva.
Do not use on sick (e. g. systemic diseases, fever) or convalescent animals.
Tużax fuq annimali morda (eż. mard sistemiku, deni) jew konvalexxenti.
This product is specifically developed for dogs.
Dan il- prodott ġie speċifikament żviluppat għall- klieb.
Do no use in cats, as this could lead to overdosing.
Tużax fuq qtates, għax jista 'jwassal għal doża eċċessiva.
Do not use on rabbits.
Tużax fuq fniek.
This veterinary medicinal product is for the treatment of ticks and adult fleas.
Dan il- prodott mediċinali veterinarju qiegħed għat- trattament ta ’ qurdien u briegħed adulti.
All dogs in a household should be treated.
Il- klieb kollha fid- dar għandhom jiġu ttrattati.
In cases of heavy infestation prior to treatment, the dog’ s surrounding should be vacuumed and treated with a suitable insecticide.
F’ każijiet ta ’ infestazzjonijiet qawwija qabel it- trattament, il- madwar tal- kelb għandu jiġi vakumjat u trattat b’ insettiċida apposta.
Dogs should not be bathed or shampooed from 48 hours before treatment.
Il- klieb m’ għandhomx jiġu maħsula jew maħsula bix- xampù għal 48 siegħa qabel it- trattament.
Immersion of the animal in water or shampooing within 24 hours after treatment may reduce the efficacy of the veterinary medicinal product.
L - immersjoni ta ’ l- annimal fl- ilma jew il- ħasil bix- xampù fi żmien 24 siegħa wara t- trattament jista ’ jnaqqas l- effikaċja tal- prodott mediċinali veterinarju.
However, weekly immersion in water did not affect efficacy against fleas and ticks.
Madankollu, l- immersjoni fl- ilma kull ġimgħa ma effettwatx l- effikaċja kontra l- briegħed u l- qurdien.
i) Special precautions for use in animals
i) Prekawzjonijiet speċjali għall- użu fl- annimali
This veterinary medicinal product is for spot-on application only.
Dan il- prodott mediċinali veterinarju qiegħed biss għal applikazzjoni spot- on.
Do not administer orally or via any other route.
Tagħtix mill- ħalq jew permezz ta ’ xi mod ieħor.
Care should be taken to avoid contact of the veterinary medicinal product with the eyes of the animal.
Għandha tingħata attenzjoni sabiex jiġi evitat kull kuntatt tal- prodott mediċinali veterinarju ma 'għajnejn l- annimal.
It is important to apply the dose to an area where the dog 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 il- kelb ma jkunx jista ’ jilgħaqha u li tagħmel żgura li l - annimali ma jilagħqux lil xulxin wara t- trattament.
Following treatment, ticks will detach from the host within 24 to 48 hours after infestation; however, single ticks might remain on the animal.
Wara t- trattament, il- qurdien jinqalgħu minn fuq l- ospitu fi żmien 24 sa 48 siegħa wara l- infestazzjoni; madankollu, xi wħud mill- qurdien jistgħu jibqgħu fuq l- annimal.
For this reason, a transmission of infectious diseases by ticks cannot be completely excluded.
Għal din ir- raġuni, it- trasmissjoni ta ’ mard infettiv mill- qurdien ma tistax tiġi eskluża kompletament.
ii) Special precautions to be taken by the person administering the medicinal product to animals
ii) Prekawzjonijiet speċjali li għandhom jittieħdu mill- persuna li tamministra l- prodott mediċinali
As a precautionary measure, direct contact with the treated animals should be avoided and children should not be allowed to play with treated animals until the application site is dry.
Bħala miżura ta ’ prekawzjoni, il- kuntatt dirett ma ’ annimali ttrattati għandu jiġi evitat u t- tfal m’ għandhomx jitħallew jilagħbu ma ’ annimali ttrattati sakemm is- sit ta ’ l- applikazzjoni ikun nixef.
It is therefore recommended to treat animals in the evening.
Għalhekk, hu rakkomandat li l- annimali jiġu ttrattati filgħaxija.
Recently treated animals should not be allowed to sleep in the same bed as their owners, especially children.
Annimali ttrattati riċentement m' għandhomx jitħallew jorqdu fl- istess sodda mas- sidien tagħhom, speċjalment it- tfal.
People with known hypersensitivity to the phenylpyrazole class compounds or any of the excipients should avoid contact with the veterinary medicinal product.
Persuni b’ sensittività eċċessiva magħrufa għas- sustanzi tal- klassi ta 'phenylpyrazole jew xi wieħed mis- sustanzi mhux attivi għandhom jevitaw kuntatt mal- prodott mediċinali veterinarju.
Avoid skin contact with the pipette content.
3 Tħallix il- kontenut tal- pipetta jmiss mal- ġilda.
Wash hands or other exposed body parts after use with soap and water.
Aħsel sew idejk jew il- partijiet l- oħra tal- ġisem esposti, bl- ilma u s- sapun.
If accidental eye exposure occurs, the eyes should be rinsed carefully with water.
Jekk jintlaqtu l- għajnejn b' mod aċċidentali, l- għajnejn għandhom jitbaħbħu sew bl - ilma.
Do not smoke, eat or drink during application.
Waqt l- applikazzjoni, la għandek tpejjep u lanqas tiekol jew tixrob.
3 iii) Other precautions
iii) Prekawzjonijiet oħra
Care should be taken to avoid excessive wetting of the hair with the product since this will cause a clogged appearance of hair at the treatment spot.
Għandha tingħata attenzjoni, biex jiġi evitat li l- pil jixxarrab b' mod eċċessiv għax dan jikkaġuna dehra mxekkla tal- pil fil- post tat- trattament.
However, should this occur, it will disappear within 24 hours post application.
Madankollu, jekk dan iseħħ, din tisparixxi fi żmien 24 siegħa wara l- applikazzjoni.
4.6 Adverse reactions (frequency and seriousness)
4. 6 Reazzjonijiet avversi (frekwenza u gravità)
The following local reactions may be observed at the application site: fur discoloration, local alopecia or pruritus.
Ir- reazzjonijiet lokali li ġejjin jistgħu jiġu osservati fil- lok ta 'l- applikazzjoni: tibdil fil- kulur tal- pil, alopeċja lokali jew prurite.
Local cosmetic effects at the application site, such as a greasy appearance or clumpiness of hair are common.
Effetti kosmetiċi lokali fis- sit ta ’ l- applikazjoni, bħal dehriet imxaħħma jew imgeddsa tal- pil huma komuni.
However, those signs disappear within 24 hours of the application.
Madankollu, dawn is- sinjali jisparixxu fi żmien 24 siegħa mill - applikazzjoni.
A brief period of hypersalivation may occur if the animal licks the application site immediately after treatment.
Perijodu qasir ta ’ salivazzjoni eċċessiva jista ’ jseħħ jekk l- annimal jilgħaq is- sit ta ’ l- applikazzjoni immedjatament wara t- trattament.
This is not a sign of intoxication and disappears within minutes without treatment.
Din mhix sinjal ta ’ intossikazzjoni u tisparixxi fi żmien ftit minuti mingħajr kura.
Correct application will minimise licking of the application site.
Applikazzjoni korretta tnaqqas il- lgħiq fis- sit ta ’ l- applikazzjoni.
4.7 Use during pregnancy and lactation
4. 7 Użu fit- tqala u effetti fuq il- ħalib tas- sider
The safety of the veterinary medicinal product has not been established during pregnancy and lactation, nor in breeding animals, although in laboratory animal studies no indications of relevant effects on reproduction or fetal development were observed.
Is- sigurtà tal- prodott mediċinali veterinarju ma ġietx stabbilita waqt it- tqala u treddigħ u lanqas f’ annimali li jitgħammru, għalkemm fi studji f’ annimali fil- laboratorju l- ebda indikazzjonijiet ta ’ effetti relevanti fuq ir- riproduzzjoni jew l- iżvilupp tal- fetu ma ġew osservati.
Use only accordingly to the benefit/ risk assessment by the responsible veterinarian.
Uża biss skond l- istima ta ’ benefiċċju/ riskju minn veterinarju responsabbli.
Spot-on use
4. 5 Effetti fuq prodotti mediċinali oħra jew effetti oħra
Dosage Schedule
Xejn li hu magħruf
The recommended minimum dose is 12.5 mg pyriprole per kg bodyweight, equivalent to 0.1 ml Prac- tic spot-on solution per kg bodyweight.
4. 9 Doża rakkomandata u l- metodu ta 'amministrazzjoni
Weight of dog
Użu spot- on
Pipette size to be Volume of 12.5%
Id- doża minima rakkomandata hija ta ’ 12. 5 mg pyriprole kull kg ta 'piż korporali, ekwivalenti għal 0. 1ml ta ’ PRAC- TIC spot- on kull kg ta' piż korporali.
used
li trid tinyuża
(w/ v) solution (ml)
soluzzjoni ta '12. 5% (w/ v)
(mg/ kg bw)
(mg / kg bw)
Very small dog Small dog Medium dog Large dog
Kelb żgħir ħafna Kelb żgħir Kelb medju Kelb kbir
Use the appropriate combination of pipettes
Uża l- kombinazzjoni xierqa ta 'pipetti
the entire contents of the correct size pipette should be used.
Fi ħdan kull faxxa ta 'piżijiet, għandu jintuża l- kontenut sħiħ tad- daqs korrett ta' pipetti.
Flea treatment and prevention
Trattament u prevenzjoni għall- briegħed
Pyriprole kills fleas within 24 hours post exposure.
4 Pyriprole joqtol il- briegħed fi żmien 24 siegħa wara l- esponiment.
One application prevents flea infestation for 4 weeks.
Applikazzjoni waħda timpedixxi infestazzjoni bil- briegħed għal 4 ġimgħat.
The veterinary medicinal product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.
Il- prodott mediċinali veterinarju għandu jiġi mogħti f’ intervalli ta ’ xahar meta użat bħala parti minn strateġija ta ’ trattament għal dermatité allerġika mill - briegħed.
4 Tick treatment and prevention
Trattament u prevenzjoni tal- qurdien
Pyriprole kills ticks within 48 hours post-exposure.
Pyriprole joqtol il- qurdien fi żmien 48 siegħa wara l- esponiment.
One application has acaricidal efficacy duration of 4 weeks.
Applikazzjoni waħda għandha effikaċja akariċidali għal tul ta ’ 4 ġimgħat.
For external use only.
Biex jintuża fuq barra biss.
Hold it in an upright position.
Żommha f' pożizzjoni wieqfa.
Tap the narrow part of the pipette to ensure the contents remain within the main body of it.
Taptap il- parti dejqa tal- pipetta sabiex tiżgura li l- kontenut jibqa 'fil- parti ewlenija tagħha.
Break the top of the snap-off top along the scored line.
Kisser il- parti ta 'fuq tal- parti li titqaċċat mal- linja mibruxa.
Part the coat on the back of the animal between the shoulder blades until the skin is visible.
Ifred il- pil fuq dahar l- annimal bejn il- ġwienaħ ta ’ l- ispallejn sakemm tidher il- ġilda.
Place the tip of the pipette on the skin and squeeze it gently several times at one or two spots to empty the contents onto the skin.
Qiegħed it- tarf tal- pipetta fuq il- ġilda u agħfas bil- ġentilezza ftit drabi f’ post wieħed jew tnejn biex tbattal il- kontenut għal fuq il- ġilda.
Apply the 5 ml pipette to 2-3 spots down the backline of large dogs in order to prevent run-off.
Applika l- pipetta ta ’ 5 ml fuq 2- 3 postijiet tul id- dahar ta ’ klieb kbar sabiex timpedixxi l- ġiri (tal- mediċina).
Mild neurological signs such as slight incoordination and unsteadiness were observed in some animals treated once a month at three times the recommended maximum dose for six consecutive months.
Ġew osservati sinjali newroloġiċi ħfief bħal nuqqas ta ’ koordinazzoni ħafifa jew nuqqas ta ’ stabbilità f’ xi annimali ttrattati darba fix- xahar bi tliet darbiet id- doża rakkomandata għal sitt xhur konsekuttivi.
Those signs disappeared within 3 hours following administration.
Dawk is- sinjali sparixxew fi żmien 3 sigħat wara l- għoti tal- mediċina.
In one out of 8 dogs repeatedly treated with five times the recommended dose, the following transient adverse effects were observed: tremors, ataxia, panting and convulsions.
F’ wieħed minn 8t iklieb trattati ripetutament b' ħames darbiet id- doża rakkomandata, l- effetti avversi għaddiena li ġejjin kienu osservati: tregħid, atassja, tleħħiġ u aċċessjonijiet.
These signs disappeared within 18 hours following administration.
Dawn is- sinjali sparixxew fi żmien 18- il siegħa.
Following an overdose of 10 times the maximum dose on a single occasion the following adverse effects were seen: vomiting, anorexia, reduced body weight, muscle tremors, seizures, unsteadiness, laboured breathing.
Wara doża eċċessiva ta ’ 10 darbiet id- doża massima f’ okkażjoni ta ’ darba, ġew osservati l- effetti avversi li ġejjin: rimettar, anoressja, tnaqqis fil- piż korporali, tregħid fil- muskoli, aċċessjonijiet, nuqqas ta ’ sodizza, nifs bagħtut.
All signs resolved within 48 hours, with the exception of the loss of appetite.
Is- sinjali kollha marru fi żmien 48 siegħa, ħlief għan- nuqqas t’ aptit.
An overdose of the veterinary medicinal product will cause a clogged appearance of hair at the treatment spot for up to 24 hours.
Doża eċċessiva tal- prodott mediċinali veterinarju tikkaġuna dehra mxekkla tal- pil fil- post ittrattat sa 24 siegħa wara.
4.11 Withdrawal period(s)
4. 11 Perijodu ta 'Tiżmim
Ectoparasiticides for topical use; ATCvet code:
Ektoparasitaċidali għall- użu topiku; Kodiċi ATĊ veterinarja:
5.1 Pharmacodynamic properties
5 5. 1 Kwalitajiet Farmakodinamiċi
The veterinary medicinal product is an insecticidal and acaricidal solution for spot-on use, containing pyriprole as active ingredient.
Il- prodott mediċinali veterinarju huwa soluzzjoni insettiċidali u akariċidali li fih pyriprole bħala sustanza attiva, għall- użu dirett (spot- on).
Pyriprole is an insecticide and acaricide belonging to the phenylpyrazole class.
Pyriprole huwa insettiċida u akariċida li jappartjeni għall- klassi phenylpyrazole.
It acts by interacting with ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma- aminobutyric acid (GABA), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes.
Huwa jaġixxi billi jkollu effett mal- ligand- gated chloride channels, partikolarment dawk imxattba bin- newrotrasmettitur gamma- aminobutyric acid (GABA), b’ hekk jimblokka t- trasferiment ta ’ qabel u ta ’ wara s- sinapsi ta ’ jonji tal- klorur minn naħa għal oħra tar- riti ċellulari.
This results in uncontrolled activity of the central nervous system and death of fleas and ticks.
Dan jirriżulta f’ attività mhux ikkontrollata tas - sistema ċentrali nervuża u l- mewt tal- briegħed u l- qurdien.
In dogs, adverse reactions are associated with neurological signs caused by metabolites of the active substance.
Fil- klieb, reazzjonijiet avversi huma assoċjati ma ’ sinjali newroloġiċi kkaġunati minn metaboliti tas- sustanza attiva.
5 Parasites are killed through contact rather than by systemic exposure.
Il- parasiti huma maqtula permezz tal- kuntatt aktar milli minn esponiment sistemiku.
Pyriprole kills fleas within 24 hours and ticks (Ixodes ricinus, Rhipicephalus sanguineus, Dermacentor reticulatus, Ixodes scapularis, Dermacentor variabilis, Amblyomma americanum) within 48 hours post-exposure.
Pyripole joqtol il - briegħed fi żmien 24- il siegħa u l- qurdien (Ixodes ricinus, Rhipicephalus sanguineus, Dermacentor reticulatus, Ixodes scapularis, Dermacentor variabilis, Amblyomma americanum) fi żmien 48 siegħa wara l- esponiment.
Adult fleas are killed before they lay eggs for a minimum of 4 weeks after treatment.
"Il- briegħed adulti jiġu maqtula qabel ma jbidu mill- anqas 4 ġimgħat qabel it- trattament.
Since Prac-tic completely eliminates egg production, it breaks the flea life cycle.
Billi Prac- tic jelimina kompletament il- produzzjoni tal- bajd, huwa jkisser iċ- ċiklu tal- ħajja tal- bergħud ".
5.2 Pharmacokinetic properties
5. 2 Tagħrif Farmakokinetiċi
In dogs, after topical administration pyriprole is slowly absorbed by skin, leading to a systemic exposure by its two main metabolites.
Wara l- għoti topikali fil- klieb, pyriprole huwa assorbit bil- mod mill- ġilda, u jwassal għall- assorbiment sistemiku permezz taż- żewġ metaboliti tiegħu.
Following topical administration pyriprole is rapidly distributed in the hair coat of dogs within one day after application.
Wara l- għoti topikali, pyriprole huwa mifrux malajr fil- pil tal- klieb fi żmien ġurnata wara l - applikazzjoni.
It can be found in the hair coat throughout the treatment interval.
Huwa jista ’ jinstab fil- pil matul iż- żmien tat- trattament.
Environmental properties
Propjetajiet ambjentali, jekk applikabbli
Pyriprole may be harmful to aquatic organisms.
Pyriprole jista 'jkun ta' ħsara għall- organiżmi akwatiċi.
Special precautions for storage
Tagħrif speċjali dwar kif jinħażen
Store the pipettes in the original container in order to protect from light.
Aħżen il- pipetti fil- kontenitur oriġinali sabiex tipproteġi mid- dawl.
6.5 Nature and contents of container
6 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Immediate packaging:
L- ippakkjar li jmiss mal- prodott:
The spot on pipette is composed of a bright yellow polypropylene shell, with a pale yellow aluminium foil back coated with a polyethylene terephthalate film.
Il- pipetta spot on tikkonsisti minn qoxra safra tgħajjat tal- polypropylene, b' folja ta 'l- aluminju safra ċara miksija b' rita tal- polyethylene terephthalate.
The pipette is contained in a child resistant soft tempered aluminium foil/ PVC blister.
Il- pipetta tinsab fi blister tal- PVC/ folja ta 'l- aluminju ta' tempra ratba li hi reżistenti għat- tfal.
Outer packaging:
Pakkett ta 'barra:
Cardboard carton containing 1, 2 or 10 blisters each containing 3 pipettes.
Kartuna li fiha 1, 2 jew 10 blisters li kull waħda fiha 3 pipetti.
6 6.6 Special precautions for the disposal of unused medicinal product or waste materials, if any
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodotti mediċinali veterinarji mhux użati jew materjal ieħor għar- rimi li huwa derivat minn dawn il- prodotti
The veterinary medicinal product should not be allowed to enter surface water, as it may be harmful for aquatic organisms.
Il- prodott mediċinali veterinarju m' għandux jitħalla jidħol fl- ilma ġieri, peress li jista 'jkun ta' ħsara għall - organiżmi akwatiċi.
Calle de la Marina, 206 E-08013 Barcelona Spain
Calle de la Marina, 206 E- 08013 Barċellona Spanja
EU/ 2/ 06/ 066/ 001-012
EU/ 2/ 06\ 066\ 001- 012
DATE OF FIRST AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
PROHIBITION OF SALE, SUPPLY AND/ OR USE
PROJBIZZJONI TA 'BEJGĦ, PROVVISTA U/ JEW UŻU
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 tinsab fuq il- websajt ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA http: // www. emea. europa. eu /
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IS- SID/ IS- SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur( i) tas- sustanza bijoloġika( ċi) attiva( i)
Novartis Santé Animale S. A. S Usine de Huningue 26 rue de Chapelle F-68330 France
Novartis Santé Animale S. A. S Usine de Huningue 26 rue de Chapelle F- 68330 Franza
For animal treatment only – to be supplied only on veterinary prescription.
Biex jintuża fuq l- annimali biss – sabiex jingħata biss bi preskrizzjoni veterinarja.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Is- sid ta ’ l- awtorizzazzjoni tal- kummerċ għandu jinforma lill- Kummissjoni Ewropea dwar il- pjani ta 'tqegħid fis- suq għall- prodott mediċinali awtorizzat b' din id- deċiżjoni.
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGE {Cardboard Carton} 56.25 mg
11 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA {Kartuna} 56. 25 mg
Prac-tic 56.25 mg Spot-on solution for very small dogs
PRAC- TIC 56. 25 mg soluzzjoni spot- on għall- klieb żgħar ħafna
125 mg per ml pyriprole.
125 mg għal kull ml pyriprole.
Unit dose 0.45 ml
Doża unitarja
Pyriprole 56.25 mg
Pyriprole
Excipients:
mhux attivi:
Spot-on solution
Soluzzjoni spot- on
3 pipettes 6 pipettes 30 pipettes
3 pipetti 6 pipetti 30 pipetta
Dogs (2-4.5 kg)
Klieb (2- 4. 5 kg)
Treatment and prevention of infestations with fleas and ticks.
Trattament u prevenzjoni ta 'briegħed u qurdien.
Kills fleas before they lay eggs.
Joqtol il- briegħed qabel ibidu.
Remove one pipette from the package.
Neħħi pipetta mill- pakkett.
Then hold the pipette in an upright position.
Imbagħad żomm il- pipetta f’ pożizzjoni wieqfa.
Tap the narrow part of the pipette to ensure the contents remain within the main body of the pipette.
Tektek il- parti d- dejqa tal- pipetta sabiex tiżgura li l- kontenut jibqa ’ fil- parti prinċipali tagħha.
Break the top of the snap-off top along the scored line.
Kisser il- parti ta ’ fuq tat- tapp snap- off mal- linja mmarkata.
Part the coat on the back of the animal between the shoulder blades until the skin is visible.
Ofroq il- pil fuq dahar l- annimal bejn l- għadam ta ’ l- ispalla sakemm il- ġilda tkun tidher.
Place the tip of the pipette on the skin and squeeze the pipette gently several times at one or two spots to empty the contents onto the skin.
Poġġi t- tarf tal- pipetta fuq il- ġilda u agħfasha bil- mod diversi drabi f’ roqgħa waħda jew tnejn biex tbattal il- kontenut fuq il- ġilda.
SPECIAL WARNING(S)
TWISSIJIET SPEĊJALI OĦRA, JEKK MEĦTIEĠ
Avoid contact of the product with skin, eyes or mouth.
Evita li l- prodott jiġi f' kuntatt mal- ġilda, l- għajnejn jew il- ħalq.
Avoid direct contact with the treated animal until the application site is dry.
Evita kuntatt dirett ma 'l- annimal ittrattat sakemm is- sit ta' l- applikazzjoni jkun nixef.
Do not remove the pipette from the packaging until ready to use.
Tneħħix il- pipetta mill- pakkett qabel ma tkun lesta biex tintuża.
Do not store above 30°C
Taħżinx f' temperatura ogħla minn 30°C.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'PRODOTTI MHUX UŻATI JEW MATERJAL IEĦOR GĦAR- RIMI
The veterinary medicinal product should not be allowed to enter surface water as it may be harmful for aquatic organisms.
Il- prodott mediċinali veterinarju m' għandux jitħalla jidħol fl- ilma ġieri, peress li jista 'jkun ta' ħsara għall - organiżmi akwatiċi.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
IL- KLIEM "GĦAT- TRATTAMENT TA ’ L- ANNIMALI BISS ” U KONDIZZJONIJIET JEW RESTRIZZJONIJIET DWAR IL- PROVVISTA U L- UŻU
For animal treatment only - to be supplied only on veterinary prescription.
Biex jintuża fuq l- annimali biss – sabiex jingħata biss bi preskrizzjoni veterinarja.
Marketing authorisation holder Novartis Sanidad Animal S. L.
Sid ta ’ l- awtorizzazzjoni tal- kummerċ Novartis Sanidad Animal S. L.
EU/ 2/ 06/ 066/ 001 (3 pipettes) EU/ 2/ 06/ 066/ 002 (6 pipettes) EU/ 2/ 06/ 066/ 003 (30 pipettes)
EU/ 2/ 06/ 066/ 001 (3 pipetti) EU/ 2/ 06/ 066/ 002 (6 pipetti) EU/ 2/ 06/ 066/ 003 (30 pipetta)
Blister (56.25 mg)
Blister (56. 25 mg)
Prac-tic Spot-on for dogs Pyriprole
PRAC- TIC Spot- on għall- klieb Pyriprole
56.25 mg
56. 25 mg
ROUTE(S) OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JINGĦATA
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
IL- KLIEM "GĦAT- TRATTAMENT TA 'L- ANNIMALI BISS"
For animal treatment only.
Għat- trattament ta 'l- annimali biss
15 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW IL- FOLJI
Pipette (56.25 mg)
Pipetta (56. 25 mg)
Prac-tic 56.25 mg
PRAC- TIC 56. 25 mg
LOT {number}
LOTT {numru}
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
16 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Cardboard Carton
Kartuna
(137.5 mg)
(137. 5 mg)
Prac-tic 137.5 mg Spot-on solution for small dogs
PRAC- TIC 137. 5 mg soluzzjoni spot- on għall- klieb żgħar
Unit dose 1.1 ml
Doża unitarja
Pyriprole 137.5 mg
Pyriprole
Dogs (> 4.5-11 kg)
Klieb (> 4. 5- 11 kg)
Do not store above 30°C
Taħżinx f' temperatura ogħla minn 30°C
EU/ 2/ 06/ 066/ 004 (3 pipettes) EU/ 2/ 06/ 066/ 005 (6 pipettes) EU/ 2/ 06/ 066/ 006 (30 pipettes)
EU/ 2/ 06/ 066/ 004 (3 pipetti) EU/ 2/ 06/ 066/ 005 (6 pipetti) EU/ 2/ 06/ 066/ 006 (30 pipetta)
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Blister (137.5 mg)
19 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR Blister (137. 5 mg)
137.5 mg
137. 5 mg
20 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Pipette (137.5 mg)
20 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW IL- FOLJI Pipetta (137. 5 mg)
Prac-tic 137.5 mg
PRAC- TIC 137. 5 mg
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
(275 mg)
Kartuna (275 mg)
Prac-tic 275 mg Spot-on solution for medium dogs
PRAC- TIC 275 mg soluzzjoni spot- on għall- klieb medji
Unit dose 2.2 ml
Doża unitarja
Dogs (> 11-22 kg)
Klieb (> 11- 22 kg)
EU/ 2/ 06/ 066/ 007 (3 pipettes) EU/ 2/ 06/ 066/ 008 (6 pipettes) EU/ 2/ 06/ 066/ 009 (30 pipettes)
EU/ 2/ 06/ 066/ 007 (3 pipetti) EU/ 2/ 06/ 066/ 008 (6 pipetti) EU/ 2/ 06/ 066/ 009 (30 pipetta)
24 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Blister (275 mg)
24 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR Blister (275 mg)
25 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
25 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- BLISTERS JEW IL- FOLJI
Prac-tic 275 mg
PRAC- TIC 275 mg
NAME OF THE MARKETING AUTHORISATION HOLDER
L- ISEM U L- INDIRIZZ TAS- SID TA ’ L- AWTORIZZAZZJONI TAL- KUMMERĊ
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
26 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Cardboard Carton (625 mg)
Kartuna (625 mg)
Prac-tic 625 mg Spot-on solution for large dogs
PRAC- TIC 625 mg soluzzjoni spot- on għall- klieb kbar
Unit dose 5.0 ml
Doża unitarja
Dogs (> 22-50 kg)
Klieb (> 22- 50 kg)
Place the tip of the pipette on the skin and squeeze the pipette gently several times at 2-3 spots down the back-line of large dogs to prevent runoff.
Poġġi t- tarf tal- pipetta fuq il- ġilda u agħfasha bil- mod diversi drabi f’ roqgħa waħda jew tnejn biex tbattal il- kontenut fuq il- ġilda.
EU/ 2/ 06/ 066/ 010 (3 pipettes) EU/ 2/ 06/ 066/ 011 (6 pipettes) EU/ 2/ 06/ 066/ 012 (30 pipettes)
EU/ 2/ 06/ 066/ 010 (3 pipetti) EU/ 2/ 06/ 066/ 011 (6 pipetti) EU/ 2/ 06/ 066/ 012 (30 pipetta)
29 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
29 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- IPPAKKJAR EWLIENI TA 'PAKKETTI ŻGĦAR
Prac-tic 625 mg
PRAC- TIC 625 mg
32 PACKAGE LEAFLET
32 FULJETT TA 'TAGĦRIF
Prac-tic spot-on solution for dogs
PRAC- TIC spot- on għall- klieb
Read this leaflet before use and administer the veterinary medicinal product with caution.
Aqra dan il- fuljett sabiex tuża u tamministra l- prodott mediċinali veterinarju b' attenzjoni.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT
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
Marketing authorisation holder:
Sid ta ’ l- awtorizzazzjoni tal- kummerċ:
Novartis Santé Animale S. A. S Usine de Huningue 26, rue de la Chapelle F-68332 Huningue Cedex France
Usine de Huningue 26, rue de la Chapelle F- 68332 Huningue Cedex Franza
Each ml contains 125 mg pyriprole as a colourless to yellow, clear solution.
Kull ml fih 125 mg pyriprole bħala soluzzjoni ċara ta 'mingħajr kulur li tkanġi fl- isfar.
The solution also contains 0.1% Butylhydroxytoluene (E321)
Is- soluzzjoni fiha wkoll 0. 1% Butylhydroxytoluene (E321)
Treatment and prevention of flea infestation (Ctenocephalides canis and C. felis.).
Trattament u prevenzjoni t’ infestazzjoniiet bil- briegħed (Ctenocephalides canis u C. felis) fi klieb.
Prac-tic is effective against new infestations with fleas for a minimum duration of 4 weeks.
PRAC- TIC huwa effettiv kontra infestazzjonijiet ġodda bil- briegħed għal perijodu minimu ta '4 ġimgħat.
The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
Il- prodott jista ’ jintuża bħala parti minn strateġija tat- trattament għall- kontroll ta ’ Dermatité Allerġika tal- Briegħed (FAD).
Treatment and prevention of tick infestation (Ixodes ricinus, Ixodes scapularis, Dermacentor variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus, Amblyomma americanum).
It- trattament u l- prevenzjoni ta ’ infestazzjonijiet bil- qurdien (Ixodes ricinus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor reticulatus, Dermacentor variabilis, Amblyomma americanum).
Prac-tic has a persistent effect for 4 weeks against ticks.
PRAC- TIC għandu effett persistenti għal 4 ġimgħat kontra l- qurdien.
Do not use in dogs less than 8 weeks of age or weighing less than 2 kg.
Tużax fuq klieb li għandhom inqas minn 8 ġimgħat jew li jiżnu inqas minn 2 kg.
Do not use in case of known hypersensitivity to phenylpyrazole class compounds or to any of the excipients.
Tużax f' każijiet ta 'sensittività eċċessiva magħrufa għas- sustanzi tal- kategorija ta' phenylpyrazole jew sustanzi oħra.
Do not use in sick or convalescent animals.
Tużax fuq annimali morda jew konvalexxenti.
ADVERSE REACTIONS
REAZZJONIJIET AVVERSI
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Jekk tinnota xi effetti serji jew effetti oħra mhux imsemmija f’ dan il- fuljett, jekk jogħġbok informa lit - tabib veterinarju tiegħek
For spot-on use.
Għall- użu spot- on.
The recommended minimum dose is 12.5 mg/ kg bodyweight pyriprole, equivalent to 0.1 ml/ kg bodyweight of the veterinary medicinal product.
Id- doża minima rakkomandata hija ta ’ 12. 5 mg pyriprole kull kg ta 'piż korporali, ekwivalenti għal 0. 1 ml/ kg piż korporali tal- prodott mediċinali veterinarju.
Within each weight band the entire contents of the correct size pipette should be used.
Fi ħdan kull faxxa ta 'piżijiet, għandu jintuża l - kontenut sħiħ tad- daqs korrett ta' pipetti.
Weight of dog
Piż tal- kelb
Pipette size to be
Daqs tal- pipetta
Volume of 12.5%
Volum ta '(ml)
(mg / kg bw)
(mg / kg bw)
2 – 4.5 kg
2
12.5 – 28.1
– 4. 5 kg
4.5 – 11 kg 11 – 22 kg 22 – 50 kg
4. 5 – 11 kg 11 – 22 kg 22 – 50 kg
Small dog Medium dog Large dog
Kelb żgħir Kelb medju Kelb kbir
1.1 2.2 5.0
1. 1 2. 2 5. 0
12.5 – 30.6 12.5 – 25.0 12.5 – 28.4
12. 5 – 30. 6 12. 5 – 25. 0 12. 5 – 28. 4
More than 50 kg
Aktar minn 50 kg
The appropriate combination of pipettes
Il- kombinazzjoni xierqa ta 'pipetti
34 Flea treatment and prevention
Trattament u prevenzjoni għall- briegħed
Pyriprole kills fleas within 24 hours post exposure.
Pyriprole joqtol il- briegħed fi żmien 24 siegħa wara l- esponiment.
One treatment prevents future flea infestation for 4 weeks.
Trattament wieħed jimpedixxi infestazzjoni bil- briegħed futura għal 4 ġimgħat.
Tick treatment and prevention
Trattament u prevenzjoni tal- qurdien
One treatment has efficacy duration of 4 weeks.
Trattament wieħed għandu effikaċja akariċidali għal tul ta ’ 4 ġimgħat.
Then hold it in an upright position.
Imbagħad żommha f' pożizzjoni wieqfa.
Tap the narrow part of the pipette to ensure the contents remain within the widest part.
Taptap fuq il- parti d- dejqa tal- pipetta sabiex tiżgura li l- kontenut jibqa 'fil- parti l- wiesgħa tagħha.
Apply the 5 ml pipette to 2-3 spots down the backline of large dogs so as to prevent run-off.
Applika l- pipetta ta ’ 5 ml fuq 2- 3 postijiet tul id- dahar ta ’ klieb kbar sabiex timpedixxi l- ġiri (tal- mediċina).
However, should this happen it will disappear within 24 hours.
Meta tamministra l- prodott, ipprova evita li xxarrab il- pil billi dan iwassal għal dehra mħarbta Madankollu, jekk dan iseħħ, dan jisparixxi fi żmien jumejn.
In cases of heavy infestation with fleas prior to treatment, the dog’ s surrounding should be vacuumed and treated with a suitable insecticide.
F’ każijiet ta ’ infestazzjonijiet qawwija bil- qurdien qabel it- trattament, il- madwar tal- kelb għandu jiġi vvakumjat u ttrattat b’ insettiċida apposta.
11 SPECIAL STORAGE PRECAUTIONS
11 PREKAWZJONIJIET SPEĊJALI GĦALL- ĦAŻNA
Do not use after the expiry date stated on the pipette after “ EXP”.
Tużax wara d- data ta 'l- iskadenza dikjarata fuq il- pipetta wara "jiskadi".
Do not store above 30°C.
Taħżinx f' temperatura ogħla minn 30°C
People with known allergies to the phenylpyrazole class of compounds or either of the excipients should avoid contact with the veterinary medicinal product.
Persuni b’ allerġiji għall- klassi ta 'komposti ta' phenylpyrazole jew għal xi waħda mis- sustanzi mhux attivi, għandhom jevitaw kuntatt mal- prodott mediċinali veterinarju.
Avoid the contents coming into contact with your fingers.
Evita il- kuntatt bejn il- kontenut u s- swaba.
Wash your hands after use and wash off any product in contact with your skin with soap and water.
Laħlaħ idejk wara li tuża u aħsel kull prodott li jiġi f' kuntatt mal- ġilda tiegħek bis- sapun u l- ilma.
If the veterinary medicinal product accidentally gets in your eyes, rinse them carefully with water.
Jekk il- prodott mediċinali veterinarju jiġi f' għajnejk b' mod aċċidentali, laħlaħhom b' attenzjoni fl- ilma.
If you or anybody else accidentally swallows this veterinary medicinal product, seek medical advice immediately and show this leaflet or the label to your doctor.
Jekk int jew xi ħadd ieħor jibla 'b' mod aċċidentali dan il- prodott mediċinali veterinarju, fittex il- parir mediku u uri dan il- fuljett jew it- tikketta lit- tabib tiegħek.
Do not smoke, eat or drink while handling the veterinary medicinal product.
M' għandekx tpejjep, tiekol jew tixrob meta tkun qed iżżomm il- prodott mediċinali veterinarju.
35 As a precautionary measure, direct contact with the treated animals should be avoided and children should not be allowed to play with treated animals until the application site is dry.
Bħala miżura ta ’ prekawzjoni, il- kuntatt dirett ma ’ annimali ttrattati għandu jiġi evitat u t- tfal m’ għandhomx jitħallew jilagħbu ma ’ annimali ttrattati sakemm is- sit ta ’ l- applikazzjoni ikun nixef.
This veterinary medicinal product is for skin application on dogs only, do not put it in your dog’ s mouth.
Dan il- prodott mediċinali veterinarju huwa għall- applikazzjoni fuq il- ġilda biss, u m' għandekx tpoġġih f' ħalq il- kelb.
Take care to avoid the veterinary medicinal product coming into contact with your dog’ s eyes.
Oqgħod attent li tevita li l- prodott mediċinali veterinarju jiġi f' kuntatt ma 'għajnejn il - kelb tiegħek.
Apply the dose to an area where the dog cannot lick it off and do not allow your dog or other animals lick each other following treatment.
Applika d- doża f' post fejn il- kelb ma jistax jilgħaqha u tħallix lill- kelb tiegħek jilgħaq annimali oħra wara t- trattament.
If you want to wash your dog, leave at least one day between treatment and shampooing.
Jekk tixtieq taħsel il- kelb tiegħek, ħalli ta 'lanqas jum bejn it- trattament u l- ħasil bix- xampu.
If you suspect your dog may be pregnant or if your bitch is nursing puppies or if you want to treat a breeding dog, contact your veterinarian for advice before use.
Jekk qed tissuspetta li l- kelba tiegħek hija tqila, jew jekk il- kelba qed tredda 'lill- ġriewi jew jekk tixtieq tittratta kelb/ a tat- tgħammir, ikkuntattja lill- veterinarju tiegħek qabel l- użu.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
PREKAWZJONIJIET SPEĊJALI DWAR IR- RIMI TA 'PRODOTT MHUX UŻAT JEW MATERJAL IEĦOR GĦAR- RIMI, JEKK IKUN IL- KAŻ
Medicines should not be disposed of via wastewater or household waste.
Mediċini m' għandhomx jintremew ma 'l- ilma maħmuġ jew ma' l- iskart domestiku.
Ask your veterinary surgeon how to dispose of medicines no longer required.
Staqsi lill- veterinarju tiegħek kif għandek tarmi l- mediċini li m' humiex aktar meħtieġa.
These measures should help to protect the environment.
Dawn il- miżuri għandhom jipproteġu l- ambjent.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott mediku veterinarju tinsab fuq il- websajt ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA http: // www. emea. europa. eu /)
Cardboard carton containing 1, 2 or 10 blisters of 3 pipettes.
Kartuna li fiha 1, 2 jew 10 blisters li kull waħda fiha 3 pipetti.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Għal kull tagħrif dwar dan il- prodott mediċinali veterinarju, jekk jogħġbok ikkuntattja lir - rappreżentant lokali tas- sid ta 'l- awtorizzazzjoni tal- kummerċ.
Italia:
37 Italia:
Blister (PVC/ Alu)
Folja (PVC/ Alu)
10 tablets
Folja ta ’ 10 10 pilloli pilloli
Oral use
Mill - ħalq
3 blisters of 10 tablets
3 folji ta ’ 10 30 pillola pilloli
EU/ 2/ 04/ 045/ 003
EU/ 2/ 04 // 045/ 003 Previcox
18 blisters of 180 tablets 10 tablets
18 il- folja 180 pillola ta ’ 10 pilloli
Oral paste
Pejst tal - ħalq
Previcox 57 mg chewable tablets for dogs Previcox 227 mg chewable tablets for dogs
Previcox pilloli ta ’ 227 mg li tomgħodhom għall- klieb.
57 mg 227 mg
57 mg Firocoxib 227 mg Firocoxib
Iron oxides (E172) Caramel (E150d)
Iron oxides (E172) Karamell (E150d)
Chewable tablets.
Pilloli li tomgħodhom.
Tan-brown, round, convex, engraved scored tablets.
Pilloli kannella ċari, tondi, konvessi, inċiżi u b’ talja fin- nofs.
For the relief of pain and inflammation associated with osteoarthritis in dogs.
Biex ittaffi l- uġigħ u l- infjammazzjoni assoċjati ma ’ l- ostjoartrite fil- klieb.
For the relief of post-operative pain and inflammation associated with soft-tissue and orthopaedic surgery in dogs.
Biex ittaffi l- uġigħ ta ’ wara operazzjoni u l- infjammazzjoni assoċjati ma ’ kirurġija tas- soft- tissue u ta ’ l- għadam fil- klieb.
Do not use in pregnant or lactating bitches.
Tużax fi klieb nisa li huma tqal jew qed jagħtu l- ħalib.
Do not use in animals less than 10 weeks of age or less than 3 kg body weight.
Tużax f’ annimali li għandhom anqas minn 10 ġimgħat jew li jiżnu inqas minn 3 kg.
Do not use in animals suffering from gastrointestinal bleeding, blood dyscrasia or haemorrhagic disorders.
Tużax f’ annimali li qed isofru minn emorraġija gastrointestinali, dyscrasia tad- demm jew f’ każijiet oħra ta ’ emorraġija.
The recommended dose, as indicated in the dosing table, should not be exceeded.
M’ għandhiex tingħata doża eċċessiva minn dik irrikmandata fit- tabella tad- dożaġġ.
2/ 33 Use in very young animals, or animals with suspected or confirmed impairment of renal, cardiac or hepatic function may involve additional risk.
L- użu fuq annimali żgħar ħafna, jew fuq annimali b’ suspett jew konferma ta ’ nuqqas tal- funzjonijiet tal- kliewi, qalb, jew fwied jista ’ jinvolvi riskju akbar.
If such use cannot be avoided, those dogs require careful veterinary monitoring.
Jekk dan l- użu ma jistax jiġi evitat, dawn il - klieb jeħtieġu monitoraġġ veterinarju b’ attenzjoni kbira.
Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of increased renal toxicity.
2/ 32 Evita l- użu f’ annimali deidrati, hypovolaemic jew hypotensive, peress li hemm riskju potenzjali ta ’ żieda ta ’ tossiċità fil- kliewi.
Concurrent administration of potentially nephrotoxic drugs should be avoided.
L- użu flimkien ma mediċini li huma potenzjalment nefrotossiċi għandu jiġi evitat.
Use this product under strict veterinary monitoring where there is a risk of gastrointestinal bleeding, or if the animal previously displayed intolerance to NSAIDs.
Uża dan il- prodott taħt monitoraġġ strett veterinarju fejn hemm riskju ta ’ emorraġija gastrointestinali, jew jekk l- annimal ikun wera fil- passat intolleranza għal xi mediċini anti - infjammatorji mhux sterojdi.
Renal and/ or hepatic disorders have been reported in very rare cases in dogs administered the recommended treatment dose.
Disturbi fil- kliewi u/ jew fil- fwied ġew irrapportati f’ kazijiet rari ħafna fi klieb li ġew mgħotija d- doża rrikmandata tal- kura.
It is possible that a proportion of such cases had sub-clinical renal or hepatic disease prior to the commencement of therapy.
Jista ’ jkun li uħud minn dawn il- każijiet kellhom mard sub- kliniku fil- kliewi jew fil- fwied qabel inbdiet it- terapija.
Therefore, appropriate laboratory testing to establish baseline renal or hepatic biochemistry parameters is recommended prior to and periodically during administration.
Għaldaqstant testijiet xierqa fil - laboratorju biex jiġu stabbiliti parametri biokimiċi tal- kliewi u tal- fwied huma rrikmandati qabel u perjodikament matul il- kura.
The treatment should be discontinued if any of these signs are observed: repeated diarrhoea, vomiting, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters.
Il- kura għandha titwaqqaf jekk xi wieħed minn dawn is- sinjali jiġu osservati: dijarea ripetuta, rimettar, demm fil- purgar, tnaqqis fil- piż f’ daqqa, anoreksja, telqa, degradazzjoni tal- parametri biokimiċi tal - kliewi u tal- fwied.
Wash hands after use of the product.
Aħsel idek wara li tuża l- prodott.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
F’ każ li tibla ’ bi żball, fittex parir mediku immedjatament u uri l- fuljett tal- pakkett jew it- tikketta lit - tabib.
Return halved tablets to the blister and keep out of the reach of children.
Erġa daħħal in- nofsijiet li jibqalek tal- pilloli fil- folja, u żomm il- bogħod mit- tfal.
Emesis and diarrhoea have occasionally been reported.
Ġieli ġew irrapportati każi ta ’ rimettar u dijarea.
These reactions are generally of a transitory nature and are reversible when the treatment is stopped.
Dawn l- effetti huma ġeneralment ta ’ natura transitorja u huma riversibbli meta titwaqqaf il- kura.
If adverse reactions like vomiting, repeated diarrhoea, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters occur, use of the product should be stopped and the advice of a veterinarian should be sought.
Jekk ikun hemm effetti mhux mixtieqa bħal rimettar, dijarea ripetuta, demm fil- purgar, tnaqqis f’ daqqa fil- piż, anoreksja, telqa, degradazzjoni tal- parametri biokimiċi tal- kliewi jew tal- fwied, l- użu tal- prodott għandu jitwaqqaf u jittieħed il- parir ta ’ tabib veterinarju..
As with other NSAIDs, serious adverse effects can occur and, in very rare cases, may be fatal.
Bħal fil- każ ta ’ mediċini anti - infjammatorji mhux sterojdi oħra jista jkun hemm effetti serji mhux mixtieqa, u f’ każijiet rari ħafna jistgħu jkunu serji jew fatali.
Do not use in pregnant or lactating bitches.
Tużax fi klieb nisa tqal jew li qed jagħtu l- ħalib.
Laboratory studies in rabbits have shown evidence of maternotoxic and foetotoxic effects at dose rates approximating the recommended treatment dose for the dog.
Studji fil- laboratorju fuq il- fniek ipprovdew evidenza ta 'ħsara fit- tqala u ħsara lill- fetu f’ dożi bejn wieħed u ieħor viċini għal dik irrikmandata għall- kura tal- kelb.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before the commencement of treatment with Previcox.
Kura minn qabel b’ sustanzi oħra ta ’ kontra l- infjammazzjoni tista iżżid l- effetti mhux mixtieqa jew toħloq oħrajn u għaldaqstant għandu jiġi osservat perijodu mingħajr kura għal mhux inqas minn 24 siegħa minn meta tkun se tinbeda l- kura bil- Previcox.
The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.
Dan il- perijodu mingħajr kura għandu jikkunsidra il- kwalitajiet farmakokinetiċi tal- prodotti użati qabel.
Previcox must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Il- Previcox m’ għandux jiġi amministrat flimkien ma mediċini oħra anti- infjammatorji mhux sterojdi jew glukokortikosterojdi.
Gastrointestinal tract ulceration may be exacerbated by corticosteroids in animals given non-steroidal anti-inflammatory drugs.
Ulċeri fl- apparat gastrointestinali jistgħu jaggravaw bl- użu ta ’ kortikosterojdi f’ annimali li ġew mgħotija anti- infjammatorji mhux sterojdi oħra qabel.