natgillin/translations-raw huggingface dataset:
Prac-tic should not be used in dogs less than 8 weeks old or less than 2 kg bodyweight since it has not sufficiently been studied in these animals.
Zdravila Prac- tic se ne sme uporabljati pri psih, ki so stari manj kot 8 tednov ali imajo manj kot 2 kg telesne mase, saj pri teh skupinah živali zdravilo ni bilo zadostno raziskano.
As other products of this group, Prac-tic should not be used in sick animals or dogs that have just recovered from illness.
Kot to velja za ostala zdravila iz te skupine zdravil, se zdravila Prac- tic ne sme uporabljati pri bolnih živalih ali psih, ki so pravkar okrevali od bolezni.
This product is specifically developed for dogs and should not be used in any other animal species.
To zdravilo je bilo razvito posebej za pse in se ga ne sme uporabljati pri drugih živalskih vrstah.
Prac-tic should not be allowed to enter surface water, as it may be harmful for aquatic organisms.
Zdravilo Prac- tic ne sme priti v vodotoke, ker je lahko nevarno za vodne organizme.
As a precautionary measure, direct contact with the treated dog should be avoided and children should not be allowed to play with a treated animal until the application site is dry.
Kot preventivni ukrep se je treba izogibati direktnemu stiku z zdravljenim psom in preprečiti otrokom igranje z zdravljeno živaljo, dokler področje nanosa ni suho.
Recently treated animals should not be allowed to sleep in the same bed as their owners, especially children.
Nedavno zdravljene živali ne smejo spati v isti postelji kot njihovi lastniki, zlasti ne pri otrocih.
People with known hypersensitivity to the phenylpyrazole class compounds or any of the excipients should avoid contact with Prac-tic.
Ljudje, ki so preobčutljivi na snovi iz skupine fenilpirazolov ali na katere koli druge pomožne snovi zdravila, se morajo izogibati stiku z zdravilom Prac- tic.
When administering Prac-tic, the user should not smoke, eat or drink.
Ne kadite, jejte ali pijte, medtem ko rokujete z zdravilom.
Why has Prac-tic been approved?
Zakaj je bilo zdravilo Prac- tic odobreno?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Prac-tic exceed the risks for the treatment and prevention of flea and tick infestations in dogs; and recommended that Prac-tic be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristi zdravila Prac- tic za zdravljenje in preprečevanje infestacij z bolhami in klopi pri psih večji od z njim povezanih tveganj, zato priporoča odobritev dovoljenja za promet z zdravilom Prac- tic.
Other information about Prac-tic:
Druge informacije o zdravilu Prac- tic:
The European Commission granted a marketing authorisation valid throughout the European Union, for Prac-tic to Novartis Sanidad Animal on 18.12.2006.
Evropska komisija je dovoljenje za promet z zdravilom Prac- tic, veljavno po vsej Evropski uniji, odobrila družbi Novartis Sanidad Animal dne 18. 12. 2006.
This summary was last updated on 18.12.2006.
Ta povzetek je bil nazadnje posodobljen 18. 12. 2006..
Invented Name
Ime
Dog
psi
1 aluminium foil/ PVC blister
1 alu/ PVC pretisni omot
2 aluminium foil/ PVC blisters
2 alu/ PVC pretisni omot
10 aluminium foil/ PVC blisters
10 alu/ PVC pretisni omot
275 mg
275 mg Kožne kapljice, raztopina
625 mg
625 mg Kožne kapljice, raztopina
10 aluminium foil/ PVC blisters
10 alu / PVC pretisni omot
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 kožni nanos, raztopina za zelo majhne pse Prac- tic 137, 5 mg kožni nanos, raztopina za majhne pse Prac- tic 275 mg kožni nanos, raztopina za srednje velike pse Prac- tic 625 mg kožni nanos, raztopina za velike pse
Each ml contains 125 mg pyriprole.
1 ml vsebuje 125 mg piriprola.
Each pipette of Prac-tic delivers the following:
1 merilna kapalka Prac- ticA sprošča naslednje količine:
Unit dose
odmerek
Pyriprole
piriprol
Prac-tic for very small dogs Prac-tic for small dogs Prac-tic for medium dogs Prac-tic for large dogs
Prac- tic za zelo majhne pse Prac- tic za majhne pse Prac- tic za srednje velike pse Prac- tic za velike pse
0.1% Butylhydroxytoluene (E321)
0, 1% Butilhidroksitoluen (E321) Za celoten seznam pomožnih snovi, glejte razdelek 6. 1.
Colourless to yellow, clear spot-on solution
kožni nanos, raztopina brezbarvna do rumena raztopina
Treatment and prevention of flea infestation (Ctenocephalides canis and C. felis) in dogs.
Zdravljenje in preprečevanje infestacij z bolhami (Ctenocephalides spp.) pri psih.
Insecticidal efficacy duration against new infestations with fleas persists for a minimum of 4 weeks.
Insekticidni učinek proti novim infestacijam z bolhami traja najmanj 4 tedne.
The veterinary medicinal product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD).
Izdelek se lahko uporablja kot del strategije zdravljenja za obvladovanje alergijskega dermatitisa, ki ga povzročijo bolhe (FAD).
Treatment and prevention of tick infestation (Ixodes ricinus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor reticulatus, Dermacentor variabilis, Amblyomma americanum) in dogs.
Zdravljenje in preprečevanje infestacij s klopi (Ixodes ricinus, Ixodes hexagonus, Ixodes scapularis, Dermacentor variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus, Amblyomma americanum) pri psih.
The veterinary medicinal product has persistent acaricidal efficacy duration of 4 weeks against ticks.
Učinek Prac- tica proti klopom traja 4 tedne.
Do not use in dogs less than 8 weeks of age or with a body weight of less than 2 kg.
Zdravila se ne sme uporabljati pri psih, mlajših od 8 tednov ali psih, ki tehtajo manj kot 2 kg.
Do not use in case of known hypersensitivity to phenylpyrazole class compounds or any of the excipients.
Prav tako se zdravila ne sme uporabljati v primeru znane preobčutljivosti na snovi iz skupine fenilpirazolov ali na katero koli pomožno snov.
Do not use on sick (e. g. systemic diseases, fever) or convalescent animals.
2 Zdravila ne uporabljajte pri bolnih živalih (n. pr. pri sistemskih boleznih, vročici) ali okrevajočih živalih.
This product is specifically developed for dogs.
Zdravilo je bilo razvito izrecno za pse.
Do no use in cats, as this could lead to overdosing.
Ne uporablja se pri mačkah, ker lahko pride do predoziranja.
Do not use on rabbits.
Ne uporablja se pri kuncih.
All dogs in a household should be treated.
Zdraviti se morajo vsi psi v reji.
In cases of heavy infestation prior to treatment, the dog’ s surrounding should be vacuumed and treated with a suitable insecticide.
V primeru večje infestacije je potrebno pred zdravljenjem mesto okrog psa posesati in uporabiti primeren insekticid.
i) Special precautions for use in animals
i) Posebni previdnostni ukrepi za uporabo pri živalih
Do not administer orally or via any other route.
To zdravilo za uporabo v veterinarski medicini se uporablja samo za nanos na kožo; ne dajajte ga peroralno ali na kakršen koli drug način.
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.
Pomembno je, da nanesemo zdravilo na mesto, kjer ga pes ne bo mogel polizati in da zagotovimo, da živali po zdravljenju ne ližejo druga druge.
For this reason, a transmission of infectious diseases by ticks cannot be completely excluded.
Praviloma klopi odpadejo z gostitelja v 24. do 48. urah po nanosu, vendar pa lahko nekaj klopov ostane na živali, zato prenosa nalezljivih bolezni s klopi ni mogoče povsem izključiti.
ii) Special precautions to be taken by the person administering the medicinal product to animals
ii) Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
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.
Prav tako ne dovolimo otrokom, da se igrajo z živalmi, ki jih zdravimo, dokler ni mesto nanosa suho.
It is therefore recommended to treat animals in the evening.
Zato svetujemo, da živali namažete zvečer.
Recently treated animals should not be allowed to sleep in the same bed as their owners, especially children.
Pravkar namazani živali ne dovolite, da spi v isti postelji kot lastnik, še posebej velja to za otroke.
People with known hypersensitivity to the phenylpyrazole class compounds or any of the excipients should avoid contact with the veterinary medicinal product.
Osebe z znano preobčutljivostjo na spojine iz skupine fenilpirazolov ali na katero koli od pomožnih snovi naj se izogibajo stiku z zdravilom.
If accidental eye exposure occurs, the eyes should be rinsed carefully with water.
Če zdravilo nehote zaide v oči, je treba oči skrbno sprati z vodo.
3 iii) Other precautions
iii) Drugi previdnostni ukrepi
However, should this occur, it will disappear within 24 hours post application.
Pazite, da dlak na mestu nanosa ne omočite preveč, sicer se dlake na mestu nanosa lahko zlepijo, kar pa izgine v 24 urah po nanosu zdravila.
4.6 Adverse reactions (frequency and seriousness)
3 4. 6 Neželeni učinki (pogostost in resnost)
The following local reactions may be observed at the application site: fur discoloration, local alopecia or pruritus.
Na mestu uporabe zdravila se lahko pojavijo naslednje kožne reakcije: razbarvanje dlak, alopecija ali pruritus.
However, those signs disappear within 24 hours of the application.
Lokalni učinki na mestu nanosa kozmetične narave kot so masten izgled ali grudice na dlakah so običajni, izginejo pa v 24 urah po nanosu.
A brief period of hypersalivation may occur if the animal licks the application site immediately after treatment.
Če pes liže mesto nanosa, je mogoče takoj po nanosu opaziti kratko obdobje prekomernega slinjenja.
Correct application will minimise licking of the application site.
Možnost, da bi pes lahko lizal mesto nanosa je majhna, če je nanos zdravila pravilen.
Use only accordingly to the benefit/ risk assessment by the responsible veterinarian.
Čeprav v laboratorijskih študijah na živalih niso dokazani učinki na reprodukcijo in razvoj zarodka, uporabljajte zdravilo le v skladu z oceno razmerja koristi/ tveganja odgovornega veterinarja.
None known.
niso znane
Dosage Schedule
Shema odmerjanja
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.
Najmanjši priporočeni odmerek je 12, 5 mg piriprola/ kg telesne mase, kar je enako 0, 1 ml Prac- tic raztopine/ kg telesne mase.
Weight of dog
masa psa (kg)
Pipette size to be Volume of 12.5%
volumen 12, 5%
(w/ v) solution (ml)
raztopine (ml)
(mg/ kg bw)
(mg/ kg tel. mase)
2 – 4.5 kg > 4.5 – 11 kg > 11 – 22 kg > 22 – 50 kg
2 – 4, 5 kg
Very small dog Small dog Medium dog Large dog
zelo majhni psi
0.45 1.1 2.2 5.0
0, 45
12.5 – 28.1 12.5 – 30.6 12.5 – 25.0 12.5 – 28.4
12, 5 – 28, 1
> 50 kg
> 4, 5 – 11 kg > 11 – 22 kg > 22 – 50 kg > 50 kg
Use the appropriate combination of pipettes
majhni psi srednje veliki psi veliki psi primerna kombinacija
Within
1, 1 2, 2 5, 0
each weight band
12, 5 – 30, 6 12, 5 – 25, 0 12, 5 – 28, 4
the entire contents of the correct size pipette should be used.
V okviru posameznega težnostnega razreda uporabite celotno vsebino ustrezne merilne kapalke.
Pyriprole kills fleas within 24 hours post exposure.
Piriprol ubije bolhe v 24 urah po aplikaciji.
One application prevents flea infestation for 4 weeks.
Eno zdravljenje prepreči infestacijo z bolhami za 4 tedne.
The veterinary medicinal product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.
Zdravilo se daje v mesečnih intervalih, kadar se uporablja kot del strategije zdravljenja alergijskega dermatitisa, ki ga povzročijo bolhe.
4 Tick treatment and prevention
Zdravljenje in preprečevanje infestacij s klopi
Pyriprole kills ticks within 48 hours post-exposure.
Piriprol ubije klope v 48 urah po aplikaciji.
One application has acaricidal efficacy duration of 4 weeks.
Akaricidni učinek enega zdravljenja traja 4 tedne.
For external use only.
samo za zunanjo uporabo
Hold it in an upright position.
Iz embalaže vzemite merilno kapalko, postavite jo pokonci.
Tap the narrow part of the pipette to ensure the contents remain within the main body of it.
Rahlo potolcite ožji del, da ostane vsebina v glavnem delu.
Break the top of the snap-off top along the scored line.
Odlomite zgornji del vzdolž zareze.
Part the coat on the back of the animal between the shoulder blades until the skin is visible.
4 Psu na hrbtu razmaknite dlako med lopaticama, da se prikaže koža.
Apply the 5 ml pipette to 2-3 spots down the backline of large dogs in order to prevent run-off.
Nanesite vsebino 5- ml merilne kapalke na 2- 3 mestih vzdolž vratnega dela hrbtenice velikih psov na tak način, da preprečite odtekanje tekočine.
4.10 Overdose (symptoms, emergency procedures, antidotes)
4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi)
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.
Pri nekaterih živalih so pri zdravljenju enkrat mesečno z trikratnim priporočenim največjim odmerkom šest mesecev zaporedoma opazili lažje nevrološke znake kot so neznatna inkoordinacija in nestabilnost.
Those signs disappeared within 3 hours following administration.
Ti znaki so izginili 3 ure po nanosu.
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.
Pri enem od osmih psov, ki so bili zdravljeni večkrat s petkratnim priporočenim odmerkom, so opazili naslednje prehodne neželene učinke: tremor, ataxijo, sopenje in konvulzije.
These signs disappeared within 18 hours following administration.
Ti učinki so izginili v 18. urah po nanosu.
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.
Pri zdravljenju z 10- kratnim največjim odmerkom so v enem primeru opazili naslednje neželene učinke: bljuvanje, anoreksijo, zmanjšanje telesne teže, mišični tremor, krče, nestabilnost, težko dihanje.
All signs resolved within 48 hours, with the exception of the loss of appetite.
Vsi ti neželeni učinki so izginili v 48 urah, razen izguba apetita.
An overdose of the veterinary medicinal product will cause a clogged appearance of hair at the treatment spot for up to 24 hours.
Uporaba čezmernega odmerka zdravila povzroči grudast izgled dlak na mestu zdravljenja, kar lahko traja do 24 ur po uporabi zdravila..
4.11 Withdrawal period(s)
Karenca
Pharmacotherapeutic group:
Farmakoterapevtska skupina: pripravek za zatiranje zunanjih zajedalcev za lokalno uporabo.
Ectoparasiticides for topical use; ATCvet code:
Oznaka ATC vet:
QP53AX26
QP53AX26.
The veterinary medicinal product is an insecticidal and acaricidal solution for spot-on use, containing pyriprole as active ingredient.
Zdravilo je insekticidna in akaricidna raztopina za lokalno uporabo, ki vsebuje piriprol kot zdravilno učinkovino.
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.
Deluje na receptorje gama- amino maslene kisline (GABA), ki je pomembna pri prenosu živčnih dražljajev v perifernem živčevju insektov in sicer tako, da se veže na mesto receptorja v klorovem kanalu in zavira prenos klorovih ionov v živčno celico.
This results in uncontrolled activity of the central nervous system and death of fleas and ticks.
Posledica tega je nenadzorovano delovanje centralnega živčnega sistema in smrt bolh in klopov.
In dogs, adverse reactions are associated with neurological signs caused by metabolites of the active substance.
Piriprol ubije bolhe v 24 urah in klope (Ixodes ricinus, Ixodes hexagonus, Ixodes scapularis, Dermacentor variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus, Amblyomma americanum) v 48 urah po izpostavljenosti.
5 Parasites are killed through contact rather than by systemic exposure.
Piriprol ubija bolhe in klope predvsem na osnovi neposrednega kontakta, delno učinkuje tudi sistemsko.
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.
Neželeni učinki pri psih se odražajo v obliki nevroloških simptomov, ki jih povzročajo razkrojni produkti aktivne učinkovine.
Adult fleas are killed before they lay eggs for a minimum of 4 weeks after treatment.
Piriprol ubije odrasle bolhe preden ležejo jajčeca za najmanj 4 tedne po zdravljenju.
Since Prac-tic completely eliminates egg production, it breaks the flea life cycle.
Ker piriprol v celoti zavira produkcijo jajčec s tem prekine življenjski ciklus bolh.
5.2 Pharmacokinetic properties
5 5. 2 Farmakokinetične posebnosti
In dogs, after topical administration pyriprole is slowly absorbed by skin, leading to a systemic exposure by its two main metabolites.
Po lokalni uporabi na psih se piriprol počasi absorbira skozi kožo, kar vodi v sistemsko porazdelitev dveh glavnih metabolitov.
Following topical administration pyriprole is rapidly distributed in the hair coat of dogs within one day after application.
Po lokalni uporabi se piriprol hitro porazdeli po dlaki psov v enem dnevu po uporabi.
Environmental properties
Okoljske lastnosti
Butylhydroxytoluene (E321) Diethylene glycol monoethyl ether
Butilhidroksi toluen E321 Dietilen glikol monoetileter
6.2 Incompatibilities
6. 2 Inkompatibnosti
Store the pipettes in the original container in order to protect from light.
Shranjujte merilne kapalke v originalni ovojnini, da so zaščitene pred svetlobo.
Do not store above 30°C.
Ne shranjujte pri temperaturi nad 30ºC.
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.
Merilna kapalka za kožni nanos, je sestavljena iz svetlo rumenega polipropilenskega telesa z bledo rumeno aluminijevo folijo, prekrito s filmom iz polietilen tereftalata.
The pipette is contained in a child resistant soft tempered aluminium foil/ PVC blister.
Merilna kapalka se nahaja v za otroke varni mehki aluminijevi foliji/ PVC pretisnem omotu.
Cardboard carton containing 1, 2 or 10 blisters each containing 3 pipettes.
Zloženka z 1, 2 ali 10 pretisnimi omoti s po 3 merilnimi kapalkami
6 6.6 Special precautions for the disposal of unused medicinal product or waste materials, if any
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz zdravila, je treba odstraniti v skladu z lokalnimi predpisi.
The veterinary medicinal product should not be allowed to enter surface water, as it may be harmful for aquatic organisms.
PRAC- TIC ne sme priti v vodotoke, ker je lahko nevaren za vodne organizme.
Calle de la Marina, 206 E-08013 Barcelona Spain
Calle de la Marina, 206 E - 08013 Barcelona Španija
EU/ 2/ 06/ 066/ 001-012
EU/ 2 // 06/ 066/ 001- 012
DATE OF FIRST AUTHORISATION
DATUM PRIDOBITVE / PODALJŠANJA DOVOLJENJA ZA PROMET
18 December 2006
18- 12 - 2006
PROHIBITION OF SALE, SUPPLY AND/ OR USE
PREPOVED PRODAJE, OSKRBE IN / ALI UPORABE
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. europa. eu
Novartis Santé Animale S. A. S Usine de Huningue 26 rue de Chapelle F-68330 France
Novartis Sante Animale S. A. S Usine de Huningue 26, rue de la Chapelle F- 68330 Francija
For animal treatment only – to be supplied only on veterinary prescription.
Samo za živali - Izdaja zdravila je le na veterinarski recept
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Imetnik dovoljenja za promet mora obvestiti Evropsko Komisijo o marketinških planih za zdravilo, ki je predmet te odločbe.
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGE {Cardboard Carton} 56.25 mg
11 PODATKI NA ZUNANJI OVOJNINI
Prac-tic 56.25 mg Spot-on solution for very small dogs
Prac- tic 56, 25 mg kožni nanos,, raztopina za zelo majhne pse
125 mg per ml pyriprole.
125 mg piriprola na ml
Each pipette of Prac-tic delivers the following:
1 merilna kapalka Prac- tic sprošča naslednje količine.
Unit dose 0.45 ml
Odmerek 0, 45 ml
Pyriprole 56.25 mg
piriprol 56, 25 mg
0.1% Butylhydroxytoluene (E321)
0, 1% butilhidroksitoluen (E321)
Spot-on solution
kožni nanos,, raztopina
Dogs (2-4.5 kg)
psi (2 - 4, 5 kg)
Treatment and prevention of infestations with fleas and ticks.
Zdravljenje in preprečevanje infestacij z bolhami in klopi
Kills fleas before they lay eggs.
Ubije bolhe preden ležejo jajčeca.
Remove one pipette from the package.
Nanos na kožo
2.
1. Iz embalaže vzemite merilno kapalko 2.
Then hold the pipette in an upright position.
Postavite jo pokonci.
Tap the narrow part of the pipette to ensure the contents remain within the main body of the pipette.
Rahlo potolcite ožji del, da ostane vsebina v glavnem delu.
Avoid direct contact with the treated animal until the application site is dry.
Izogibajte se direktnega stika s psom dokler področje nanosa ni suho.
Do not remove the pipette from the packaging until ready to use.
Merilno kapalko hranite v zunanji ovojnini, dokler je ne uporabite.
Do not store above 30°C
Ne shranjujte pri temperaturi nad 30 °C
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz zdravila je treba odstraniti v skladu z lokalnimi predpisi.
The veterinary medicinal product should not be allowed to enter surface water as it may be harmful for aquatic organisms.
Prac- tic ne sme priti v vodotoke, ker je lahko nevarno za vodne organizme.
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
BESEDILO “ SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
13 15.
13 16.
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 merilne kapalke) EU/ 2/ 06/ 066/ 002 (6 merilne kapalke) EU/ 2/ 06/ 066/ 003 (30 merilne kapalke)
< Batch > < Lot > < BN > {number}
Serija
Blister (56.25 mg)
Pretisni omot (56, 25 mg)
Prac-tic Spot-on for dogs Pyriprole
Prac- tic kožni nanos,, raztopina za pse piriprol
Spot-on
nanos na kožo
Pipette (56.25 mg)
Merilna kapalka (56, 25 mg)
Prac-tic 56.25 mg
Prac- tic 56, 25 mg piriprol
LOT {number}
Serija (mesec/ leto)
16 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
16 PODATKI NA ZUNANJI OVOJNINI
(137.5 mg)
Zloženka (137, 5 mg)
Prac-tic 137.5 mg Spot-on solution for small dogs
Prac- tic 137, 5 mg kožni nanos,, raztopina za majhne pse
Each pipette of Prac-tic delivers the following:
1 merilna kapalka Prac- tic sprošča naslednje količine:
Unit dose 1.1 ml
odmerek 1, 1 ml
Pyriprole 137.5 mg
piriprol 137, 5 mg
Dogs (> 4.5-11 kg)
psi (> 4, 5 – 11 kg)