natgillin/translations-raw huggingface dataset:
Shake the bottle thoroughly before administration
Pred uporabo stekleničko dobro pretresi.
Once opened do not store above 25 ºC.
Po odprtju ne shranjujte pri temperaturi nad 25 °C.
Bacterial and fungal otitis is often secondary in nature and appropriate diagnosis should be used to determine the primary factors involved.
Za postavitev pravilne diagnoze je potrebno ugotoviti primarni vzrok vnetja, ker so bakterije in glivice pogosto le sekundarni vzrok, ki povzroči vnetje zunanjega sluhovoda.
These measures should help to protect the environment.
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
16/ 18 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
It has been made using a ‘ recombinant DNA technique’ (when genes are inserted into an organism) to carry the H5 (haemagglutinin 5) and N3 (neuraminidase 3) antigens.
Proizveden je bil z uporabo » rekombinantne DNK tehnologije « (pri tem se geni vstavijo v organizem) za prenašanje antigenov H5 (hemaglutinin 5) in N3 (nevraminidaza 3).
This kind of ‘ reassortment ’ between H and N types happens naturally in the wild but in this case has been carried out in the laboratory to produce a virus with these very specific properties.
Ta vrsta » prerazporejanja « med tipoma H in N poteka v naravi spontano, v tem primeru pa je bila izvedena v laboratoriju z namenom, da bi izdelali virus s temi posebnimi lastnostmi.
• In chickens:
• Pri piščancih:
• In ducks:
• Pri racah:
No field trial is available for this target species.
Pri izvedenih laboratorijskih raziskavah so preučevali varnost cepiva po enem odmerku, po prevelikem odmerjanju in po režimu ponavljajočih se odmerkov.
This is acceptable because of the current political and epidemiological situation in Europe with regard to avian influenza.
Za to ciljno vrsto terenske študije niso na voljo, kar je sprejemljivo zaradi sedanje politične in epidemiološke situacije v Evropi glede aviarne influenze.
What benefit has Poulvac FluFend H5N3 RG shown during the studies? • The studies showed that the birds which receive the vaccine develop antibodies against the H5 subtype of the avian influenza virus. • The vaccine has been shown to prevent clinical signs and mortality and reduce virus shedding in infected chickens and ducks. • If the circulating avian influenza field virus has a different N component to the N3 included in the vaccine, it may be possible to differentiate between vaccinated and infected birds by using a diagnostic test to detect specific Neuraminidase antibodies.
Kakšne koristi je zdravilo Poulvac FluFend H5N3 RG izkazalo med raziskavami? • Raziskave so pokazale, da ptice, ki prejmejo cepivo, tvorijo protitelesa proti virusu aviarne influence podtipa H5. • Dokazano je bilo, da cepivo preprečuje klinične znake in umrljivost ter zmanjšuje izločanje virusa pri okuženih piščancih in racah. • Če ima krožeči divji virus aviarne influence sestavino N, ki se razlikuje od sestavine N3 v cepivu, lahko cepljene ptice razlikujemo od okuženih z diagnostičnim testom za odkrivanje protiteles proti nevraminidazi.
Page 2/ 3 ©EMEA 2008 Poulvac FluFend H5N3 RG has been authorised under “ Exceptional Circumstances”.
Stran 2 od 3 ©EMEA 2008 Zdravilo Poulvac FluFend H5N3 RG je bilo odobreno v » izjemnih okoliščinah «.
The European Commission granted a marketing authorisation valid throughout the European Union, for Poulvac FluFend H5N3 RG to Fort Dodge Animal Health on 01.09.2006.
Evropska Komisija je dovoljenje za promet z zdravilom Poulvac FluFend H5N3 RG, veljavno po vsej Evropski uniji, odobrila družbi Fort Dodge Animal Health dne 01. 09. 2006.
This summary was last updated on 31.07.2008.
Ta povzetek je bil nazadnje posodobljen 31. 07. 2008.
Page 3/ 3 ©EMEA 2008
Stran 3 od 3 ©EMEA 2008
Route of administration
Pot uporabe Ovojnina zdravila
> 1:40 HI Emulsion for units per injection dose
> 1: 40 HI enot / odmerek
Intramuscular or subcutaneous
Intramuskular - na / subkutana
500 ml
500 ml 1 cepiva
Chickens and ducks
emulzija za injiciranje
Intramuscular or subcutaneous
Piščanci in race.
High-density polyethylene bottles with rubber stopper and aluminium cap
Intramuskular - na / subkutana
500 ml
plastenke iz polietilena visoke gostote, z nitrilnim gumijastim zamaškom in aluminijasto zaporko
10 bottles
500 ml 10 cepiva Nič dni.
Poulvac FluFend H5N3 RG emulsion for injection for chickens and ducks
Poulvac FluFend H5N3 RG emulzija za injiciranje za piščance in race
One dose of 0.5 ml contains:
1 odmerek (0, 5 ml) vsebuje:
Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ ck/ VN/ C58/ 04) > 1:40 HI units per dose
Inaktivirani rekombinantni virus aviarne influence podtipa H5N3 (sev rg- A/ ck/ VN/ C58/ 04) > 1: 40 HI Enot v odmerku
White Oil Sorbitan sesquioleate Polysorbate 80
Belo olje Sorbitan seskvioleat Polisorbat 80
Thiomersal Phosphate Buffer Saline
Tiomersal Fosfatni pufer s soljo
Reduction of mortality and virus excretion after challenge.
Zmanjšanje smrtnosti in izločanja virusa po izpostavljenost.
3 weeks after the second injection.
Tri tedne po drugi injekciji.
Duration of immunity in ducks:
Čas trajanja imunske zaščite pri racah:
14 weeks after the second injection.
14 tednov od druge injekcije
No information is available on the interference of maternally derived antibodies on vaccination for both target species.
2 Za obe ciljni vrsti ni podatkov o vplivih materinih protiteles na cepljenje.
No information is available on the compatibility of this vaccine with any other.
Ni podatkov o kompatibilnosti tega cepiva s katerim koli drugim.
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.
Zato varnost in učinkovitost ob sočasni uporabi tega cepiva s katerim koli drugim (uporabljenim isti dan ali kdaj drugič) niso predstavljeni.
Chickens 3 weeks of age or older:
Piščanci Starost tri tedne ali več:
0.5 ml intramuscularly in the breast muscle.
0, 5 ml intramuskularno v prsno mišico.
Ducks At one day old:
Race Pri starosti enega dne:
0.2 ml subcutaneously in the neck.
0, 2 ml subkutano v vrat.
Revaccinate after 3 weeks:
Ponovno cepljenje po treh tednih:
0.5 ml subcutaneously in the neck The vaccination schedule should be completed at least 4 weeks before the start of laying.
Program cepljenja bi se moral zaključiti vsaj 4 tedne pred začetkom obdobja nesnosti.
3 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), če je potrebno
Following the administration of a double dose in chickens and ducks, no adverse reactions other than those described in section 4.6 have been observed.
Po vnosu dvojnega odmerka niso zasledili drugačnih neželenih učinkov, kot so opisani v poglavju 4. 6.
4.11 Withdrawal period
3 4. 11 Karenca
Inactivated recombinant vaccine, ATC vet code:
Inaktivirano rekombinantno cepivo, ATCvet oznaka:
To induce serological response against N3 neuraminidase which can act as a marker to Differentiate Infected from Vaccinated Animals (DIVA strategy).
Cepivo je namenjeno spodbujanju aktivne imunosti pri piščancih in racah proti virusu aviarne influence podtipa H5 in sproženju serološkega odziva proti N3 neuraminidazi, ki lahko služi kot marker za razlikovanje med okuženimi in cepljenimi živalmi (t. i. strategija DIVA)
White Oil Sorbitan sesquioleate Polysorbate 80 Thiomersal Sodium chloride Sodium phosphate dibasic Potassium phosphate monobasic
Belo olje Sorbitan seskvioleat Polisorbat 80 Tiomersal Natrijev klorid Natrijev fosfat, dvobazni Kalijev fosfat, enobazni
The entire content of the bottle should be used within 2 hours after broaching the container.
1 leto Vsebino plastenke morate porabiti v dveh urah po predrtju vsebnika.
Store and transport refrigerated (2° to 8°C).
Shranjujte in prevažajte v hladilniku (2 °C – 8 °C).
6.5 Nature and composition of immediate packaging
500 ml cepiva v plastenkah iz polietilena visoke gostote, z nitrilnim gumijastim zamaškom in aluminijasto zaporko
500 ml of vaccine in high-density polyethylene bottles, closed with a nitrile rubber stopper and aluminium cap.
Cepivo je v škatlah z eno ali desetimi plastenkami po 500 ml.
The vaccine is presented in boxes of 1 or 10 bottles of 500 ml.
Ni nujno, da so v prometu vsa navedena pakiranja
4 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste material derived from the use of such products
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo
Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH United Kingdom
Fort Dodge Animal Health Limited Flanders Road Hedge End Southampton SO30 4QH Združeno Kraljestvo
1 September 2006
{DD/ MM/ LLLL}
The import, sale, supply and/ or use of Poulvac FluFend H5N3 RG is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Uvoz, prodaja, oskrba in/ ali uporaba Poulvac FluFend H5N3 RG je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
Any person intending to import, sell, supply and/ or use Poulvac FluFend H5N3 RG must consult the relevant Member States competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ ali uporabljati Poulvac FluFend H5N3 RG, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ ali uporabo.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC( IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC( IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Name and address of the manufacturer of the biological active substance(s)
Ime in naslov izdelovalca( izdelovalcev) biološke zdravilne učinkovine (zdravilnih učinkovin).
Fort Dodge Animal Health Holland CJ van Houtenlaan 36 1381 CP Weesp The Netherlands
Fort Dodge Animal Health Holland CJ van Houtenlaan 36 1381 CP Weesp Nizozemska
Fort Dodge Animal Health (Charles City) 2000 Rockford Road Charles City, Iowa 50616 USA
Fort Dodge Animal Health (Charles City) 2000 Rockford Road Charles City, Iowa 50616 ZDA
According to Article 71 of Directive 2001/ 82/ EC Member States prohibit or may prohibit the import, sale, supply and/ or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
Skladno z 71. členom Direktive 2001/ 82/ ES države članice prepovejo ali lahko prepovejo uvoz, prodajo, oskrbo in/ ali uporabo zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals > b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih izdelkih, pridobljenih iz zdravljenih živali,
Pharmacologically active substance Mineral oils Arlacel 83V (sorbitan sesquioleate) Tween 80 (polyoxyethylene sorbitan monooleate)
Tween 80 (polioksietilen sorbitan Vse vrste za proizvodnjo monooleat) Natrijev klorid
Animal Species All food producing species All food producing species All food producing species
živil Vse vrste za proizvodnjo živil
Other provisions
Vse vrste za proizvodnjo živil
Sodium chloride Sodium phosphate dibasic (E339) Potassium phosphate monobasic (E340)
Enobazni kalijev fosfat (E340)
All food producing species All food producing species All food producing species
Vse vrste za proizvodnjo živil
For use only as preservatives in multidose vaccines at a concentration not exceeding 0.02%(concentration in the product is 0.004%)
Le za uporabo v obliki konzervansov v večodmernih cepivih pri koncentraciji, ki ne presega 0, 02% (koncentracija v izdelku znaša 0, 004%).
More detailed information on the specific obligations is set out in the CVMP assessment report.
Podrobnejše informacije o specifičnih obveznostih so navedene v CVMP poročilu.
1) There are important outstanding issues regarding the differences of production and control between the manufacturing sites (including the nature of the eggs used), the lack of a validation study for the potency test on finished product (it appears that final product tests are only done at Weesp but in-process tests such as titration and HA quantification need to be equivalent too) and the lack of any stability data.
1) Obstajajo pomembna nerešena vprašanja glede razlik med izdelavo in nadzorom v različnih proizvodnih obratih (vključno z lastnostmi uporabljenih jajc), ni validacijske študije za test moči (potency test) na končnem izdelku (zdi se, da se testi končnega cepiva izvajajo le v Weespu, vendar pa morajo biti testi med postopkom, kakršna sta titracija in količinska opredelitev HA, prav tako enakovredni), manjkajo podatki o stabilnosti.
In particular, a rationalization of the nature of eggs used (taking into consideration the problem of the possible presence of extraneous agents in conventional eggs and the possibility to inactivate them during the inactivation process of the Influenza virus, supported by a corresponding validation study).
To velja še posebej pri racionalizaciji lastnosti uporabljenih jajc (ob upoštevanju problema morebitne prisotnosti tujih dejavnikov v običajnih jajcih in možnosti inaktivacije le- teh med postopkom inaktivacije virusa influence, kar podpira ustrezna validacijska študija).
The Applicant is asked to commit to take appropriate measures to harmonise the productions and/ or to provide the adequate demonstrations/ data to solve the issues.
Predlagatelja prosimo, da sprejme ustrezne ukrepe za usklajevanje izdelovanja in/ ali da priskrbi primerne predstavitve/ podatke za rešitev teh vprašanj.
2) The Applicant should commit to generate stability data for the shelf life to be established.
Predlagatelj bi se moral obvezati, da bo zbral podatke o stabilnosti, da se bo določil rok uporabnosti.
8 ANNEX III
8 FARMAKOVIGILANČNI VIDIKI
LABELLING AND PACKAGE LEAFLET
3) Predlagatelj mora izročiti 3- mesečna periodična poročila o varnosti za prvi 2 leti po začetni uporabi na terenu, poleg tega pa še protokol, ki bo zagotovil ustrezno dokumentiranje in poročanje o podatkih s terena, ki se nanašajo na sum na neželene učinke in sum na neučinkovitost.
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARTON LABEL
OZNAČEVANJE
Poulvac FluFend H5N3 RG Emulsion for injection
Poulvac FluFend H5N3 RG Emulzija za injiciranje
Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ ck/ VN/ C58/ 04)
Neaktiviran rekombinantni virus aviarne influence podtipa H5N3 (sev rg- A/ ck/ VN/ C58/ 04) > 1: 40 HI Enot
Chickens 3 weeks of age or older:
Piščanci Starost treh tednov ali več:
0.2 ml subcutaneously in the neck.
0, 2 ml podkožno v vrat.
0.5 ml subcutaneously in the neck The vaccination schedule should be completed at least 4 weeks before the start of laying.
Program cepljenja bi se moral zaključiti vsaj 4 tedne pred začetkom obdobja nesenosti.
Withdrawal period - Zero days
Nič dni.
EXP (month/ year)
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Once broached, use within 2 hours.
EXP {mesec/ leto} Načeto/ odprto zdravilo uporabite v dveh urah.
Store and transport refrigerated (2° to 8°C).
Shranjujte in prevažajte pri temperaturi (2 °C – 8 °C).
THE WORDS ‘ FOR ANIMAL TREATMENT ONLY’ AND CONDITIONS OF RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO “ SAMO ZA ŽIVALI ” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
Keep out of the reach and sight of children
13 Zdravilo shranjujte nedosegljivo otrokom.
Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton UK SO30 4QH
Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton, SO30 4QH, Velika Britanija
Lot (Number)
Serija > < lot > < številka serije > {številka}
13 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
PRIMARNI OVOJNINI
Poulvac FluFend H5N3 RG Emulsion for injection
Poulvac FluFend H5N3 RG emulzija za injiciranje
Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ ck/ VN/ C58/ 04)) > 1:40 HI Units
Neaktiviran rekombinantni virus aviarne influence podtipa H5N3 (sev rg- A/ ck/ VN/ C58/ 04)) > 1: 40 HI Enot
14 weeks after the second injection.
Čas trajanja imunske zaščite pri racah:
14 7.
14 tednov od druge injekcije
Ducks At one day old:
15 Race Pri starosti enega dne:
Store and transport refrigerated (2ºC - 8ºC).
Shranjujte in prevažajte pri temperaturi (2 °C – 8 °C).
THE WORDS ‘ FOR ANIMAL TREATMENT ONLY’ AND CONDITIONS OF RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
BESEDILO “ SAMO ZA ŽIVALI ” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
THE WORDS ‘ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN’
BESEDILO “ ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ”
Fort Dodge Animal Health Ltd Flanders Road, Hedge End Southampton UK SO30 4QH
16 Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton, SO30 4QH, Velika Britanija
17 PACKAGE LEAFLET FOR:
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA
Poulvac FluFend H5N3 RG Emulsion for injection
18 NAVODILO ZA UPORABO Poulvac FluFend H5N3 RG emulzija za injiciranje
Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton UK SO30 4QH
Fort Dodge Animal Health Ltd Flanders Road, Hedge End Southampton SO30 4QH Velika Britanija
Fort Dodge Animal Health Holland
Fort Dodge Animal Health Holland C. J. van Houtenlaan 36 NL- 1381 CP Weesp Nizozemska
Poulvac FluFend H5N3 RG Emulsion of injection
Poulvac FluFend H5N3 RG emulzija za injiciranje
One dose of 0.5 ml contains:
! odmerek (0, 5 ml) vsebuje:
Inactivated recombinant avian influenza virus of H5N3 subtype (strain rg-A/ ck/ VN/ C58/ 04)
Inaktiviran rekombinantni virus aviarne influence podtipa H5N3 (sev rg- A/ ck/ VN/ C58/ 04) > 1: 40 HI Enot
19 To the user This product contains mineral oil.
Ta izdelek vsebuje mineralno olje.
To the physician This product contains mineral oil.
Ta izdelek vsebuje mineralno olje.
Following the administration of a double dose in chickens and ducks, no adverse reactions other than those described in section 6 have been observed.
Po vnosu dvojnega odmerka niso zasledili drugačnih neželenih učinkov, kot so opisani v poglavju 4. 6.
EMEA/ V/ C/ 0103 EMEA/ CVMP/ 421838/ 2006
EMEA/ V/ C/ 0103 EMEA/ CVMP/ 505416/ 2006
What is Prac-tic?
Kaj je zdravilo Prac- tic?
Prac-tic is a colourless to yellow, clear solution that contains pyriprole as active substance.
Zdravilo Prac- tic je brezbarvna do rumena bistra raztopina, ki vsebuje zdravilno učinkovino piriprol.
It is given to dogs with a pre-filled spot-on pipette, i. e. a small plastic container which is already filled with the correct amount of Prac-tic needed to treat one dog (Pract-tic is available in 4 different sizes for different dog sizes).
Daje se psom na kožo s predhodno napolnjeno merilno kapalko, t. j. majhno plastično cevko, ki je že napolnjena z ustrezno količino zdravila Prac- tic, potrebno za zdravljenje enega psa (zdravilo Prac- tic je na voljo v 4 različnih velikostih, ki ustrezajo različnim velikostim psov).
The content of the pipette is squeezed onto the skin after parting the fur between the shoulder blades of the dog.
Psu razmaknemo dlako med lopaticama, da se prikaže koža, in na to mesto stisnemo vsebino merilne kapalke.
What is Prac-tic used for?
Za kaj se zdravilo Prac- tic uporablja?
Prac-tic is an “ ectoparasiticide”, this means that it will kill parasites that live on the skin or in the fur of animals, such as fleas and ticks.
Prac- tic je zdravilo za zatiranje zunanjih zajedalcev, to pomeni, da uničuje zajedalce, ki živijo na koži ali v dlaki živali, kot so denimo bolhe in klopi.
Prac-tic is used to treat and to prevent tick and flea infestations in dogs.
Zdravilo Prac- tic se uporablja za zdravljenje in preprečevanje infestacij s klopi in bolhami pri psih.
It can also be used as part of a treatment strategy for the control of Flea Allergy Dermatitis, an allergic reaction of dogs to flea bites.
Lahko se uporablja tudi kot del strategije zdravljenja za obvladovanje alergijskega dermatitisa, ki ga povzročajo bolhe, t. j. alergijske reakcije psov na ugrize bolh.
How does Prac-tic work?
Kako zdravilo Prac- tic deluje?
The active substance of Prac-tic, pyriprole, interacts with a receptor involved in transmitting neural impulses (GABA receptor).
Zdravilna učinkovina zdravila Prac- tic, piriprol, vpliva na receptor, ki sodeluje pri prenosu živčnih dražljajev (receptor GABA).
This interferes with the nerval system of fleas or ticks and leads to the death of these parasites.
To zaviralno deluje na živčni sistem bolh ali klopov ter povzroči smrt teh zajedalcev.
How has Prac-tic been studied?
Kako je bilo zdravilo Prac- tic raziskano?
Data were provided on the pharmaceutical quality, the tolerance of the product in dogs and the safety in humans (people in contact with the product) and the environment.
Predloženi so bili podatki o farmacevtski kakovosti, toleranci na zdravilo pri psih ter njegovi varnosti za ljudi (za ljudi, ki pridejo v stik z zdravilom) in okolje.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 47 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Prac-tic shown during the studies?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Dve terenski preskušanji sta bili izvedeni pri psih v veterinarskih ambulantah v številnih evropskih državah in različnih geografskih regijah.
The results of the field trials showed that Prac-tic is effective in the treatment and prevention of flea and tick infestations in dogs.
Pse različnih ras, starostnih skupin in z različnimi telesnimi masami, ki so bili infestirani z bolhami in klopi, so zdravili bodisi z zdravilom Prac- tic ali z drugimi zdravili, ki so bila v EU odobrena za to indikacijo.
The medicine killed fleas within 24 hours and ticks within 48 hours after treatment and its effectiveness lasted for at least 4 weeks.
Zdravilo ubije bolhe v 24 urah, klope pa v 48 urah po uporabi zdravila, njegov učinek pa traja najmanj 4 tedne.
What is the risk associated with Prac-tic?
Kakšna tveganja so povezana z zdravilom Prac- tic?
The most common side effects in dogs are local reactions at the place where the product has been applied: change in the fur colour, hair loss and itchiness, as well as change in appearance of the fur (greasy appearance and clumpiness).
Najbolj pogosti neželeni učinki pri psih so lokalne reakcije na mestu nanosa zdravila: sprememba barve dlake, izpadanje dlak in srbečica kot tudi sprememba izgleda dlak (masten izgled in grudice na dlakah).