natgillin/translations-raw huggingface dataset:
Econor 10% premix for medicated feed for pigs and rabbits is available in 1 kg and 25 kg bags.
Econor 10 % predmešanica za pripravo zdravilne krmne mešanice za prašiče in kunce je na voljo v 1 kg in 25 kg vrečah.
In-feed use.
Dajanje v krmni mešanici.
The correct quantity of Econor oral powder should be added to the estimated quantity of the daily ration for each pig, in a bucket or suitable receptacle and thoroughly mixed.
V vedru ali primerni posodi je treba ocenjenemu dnevnemu obroku krme za vsakega prašiča dodati ustrezno količino peroralnega praška Econor in krmo dobro premešati.
MARKETING AUTHORISATION NUMBER(S) EU/2/98/010/021 (1 kg)
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/98/010/021 (1 kg)
The required quantity of product is thoroughly mixed with a feed ingredient of similar physical nature (e.g. wheat middlings) in the proportion: 1 part Econor 50% premix to 20 parts feed ingredient.
Priporočena količina produkta se temeljito zmeša s krmo podobnih fizikalnih lastnosti (npr. pšenični zdrob) v razmerju: 1 del Econor 50 % predmešanice na 20 delov krme.
QUALITATIVE AND QUANTITATIVE COMPOSITION Econor contains valnemulin in the form of valnemulin hydrochloride.
Econor vsebuje valnemulin v obliki valnemulinijevega klorida.
Treatment of swine dysentery caused by Brachyspira hyodysenteriae.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Zdravljenje prašičje dizenterije, ki jo povzroča Brachyspira hyodysenteriae.
STATEMENT OF ACTIVE SUBSTANCES Valnemulin 500 mg/g (equivalent to 532.5 mg/g valnemulin hydrochloride)
valnemulin 500 mg/g (enakovredno količini 532,5 mg/g valnemulinijevega klorida)
Rabbits: Meat and offal: Zero days.
Meso in organi: Nič dni.
Manufacturer's batch number Batch {number}
PROIZVAJALČEVA ŠTEVILKA SERIJE
MANUFACTURER'S BATCH NUMBER Batch {number}
Proizvajalčeva številka serije
The treatment of swine dysentery.
Zdravljenje prašičje dizenterije.
The required quantity of product is thoroughly mixed with a feed ingredient of similar physical nature (e.g. wheat middlings) and for rabbits in rabbit standard feed (e.g. mash, pellets) in the proportion: 1 part Econor 10% premix to 10 parts feed ingredient.
Priporočena količina produkta se temeljito zmeša s krmo podobnih fizikalnih lastnosti (npr. pšenični zdrob) in v standardno krmo za kunce (kaša, peleti) v razmerju: 1 del Econor 10 % predmešanice na 10 delov krme.
Valnemulin1 Valnemulin Porcine, rabbit
Terapevts ke indikacije valnemulin valnemulin Prašiči, kunci
Incorporation of 200 mg active substance per kg feed with:
Dodajanje 200 mg učinkovine/kg krme:
Treatment of swine enzootic pneumonia.
Zdravljenje prašičje enzootske pljučnice.
Treatment of clinical signs porcine proliferative enteropathy (ileitis)
Zdravljenje kliničnih znakov prašičje proliferativne enteropatije (ileitisa)
Treatment of swine dysentery
Zdravljenje prašičje dizenterije
Laboratory studies in rats and mice have not produced any evidence of teratogenic effect, however, the safety of the veterinary medicinal product in pregnant and lactating sows has not been established.
Laboratorijske študije na podganah in miših niso pokazale nobenih teratogenih učinkov, vendar pa varnost zdravila za uporabo v veterinarski medicini pri brejih in doječih svinjah ni bila potrjena.
Treatment and prevention of swine enzootic pneumonia
Preprečevanje in zdravljenje prašičje enzootske pljučnice
METHOD AND ROUTE(S) OF ADMINISTRATION In-feed use.
NAČIN IN POT(I) UPORABE
Do not administer the veterinary medicinal product to pigs or rabbits receiving ionophores.
Ne uporabite zdravila za uporabo v veterinarski medicini pri prašičih ali kuncih, ki dobivajo ionofore.
The treatment of clinical signs of porcine proliferative enteropathy (ileitis).
Zdravljenje kliničnih znakov prašičje proliferativne enteropatije (ileitisa).
Other ingredients: Hypromellose Talc
Druge sestavine: hipromeloza smukec
Most common adverse reactions observed in these pigs are pyrexia, anorexia and in severe cases ataxia and recumbency.
Najpogostejši neželeni učinki pri teh prašičih so povišana telesna temperatura in zmanjšan apetit, v hujših primerih pa ataksija in nezmožnost vstajanja (ležanje).
Special warnings for use in rabbits:
Posebna opozorila za kunce:
The required quantity of product is thoroughly mixed with a feed ingredient of similar physical nature (e.g. wheat middlings) in the proportion: 1 part Econor 10% premix to 10 parts feed ingredient.
Priporočena količina produkta se temeljito zmeša s krmo podobnih fizikalnih lastnosti (npr. pšenični zdrob) v razmerju: 1 del Econor 10 % predmešanice na 10 delov krme.
NAME OF THE VETERINARY MEDICINAL PRODUCT Econor 50% premix for medicated feed for pigs Econor 10% premix for medicated feed for pigs and rabbits
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Econor 50 % predmešanica za pripravo zdravilne krmne mešanice za prašiče Econor 10 % predmešanica za pripravo zdravilne krmne mešanice za prašiče in kunce
Treatment and prevention of swine enzootic pneumonia.
Zdravljenje in preprečevanje prašičje enzootske pljučnice.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE ALUMINIUM-LINED PLASTIC BAGS
ZDRUŽENA STIČNA OVOJNINA IN NAVODILO ZA UPORABO Z ALUMINIJEM PODLOŽENE PLASTIČNE VREČE
Do not administer the veterinary medicinal product to pigs receiving monensin, salinomycin or narasin.
Posebni previdnostni ukrepi za uporabo pri živalih Ne uporabite zdravila za uporabo v veterinarski medicini pri prašičih, ki prejemajo monenzin, salinomicin ali narazin.
Extreme care should therefore be taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and their crossbreeds thereof, especially in younger pigs.
Zato je treba biti pri uporabi zdravila Econor pri pasmah danski in švedski landrace ali križancih, ki vključujejo katero od teh pasem, zelo previden, še posebej pri mlajših prašičih.
3-4 mg/kg bodyweight/day
3-4 mg/kg telesne mase/dan
Incorporation of 75 mg active substance per kg feed with:
Dodajanje 75 mg učinkovine/kg krme:
NB: a level scoop of the veterinary medicinal product should be measured.
Pomni: nameriti je treba zvrhano zravnano žličko zdravila za uporabo veterinarski medicini.
Prevention of swine dysentery clinical signs of porcine colonic spirochaetosis (colitis)
Preprečevanje prašičje dizenterije kliničnih znakov prašičje spirohetoze debelega črevesa
PHARMACEUTICAL FORM Premix for medicated feeding stuff
FARMACEVTSKA OBLIKA Predmešanica za pripravo zdravilne krmne mešanice.
Secondary infection by organisms such as Pasteurella multocida and Actinobacillus pleuropneumoniae may complicate enzootic pneumonia and require specific medication.
Sekundarna okužba z organizmi, kot sta Pasteurella multocida in Actinobacillus pleuropneumoniae,
NAME OF THE VETERINARY MEDICINAL PRODUCT Econor 10% oral powder for pigs
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Econor 10 % peroralni prašek za prašiče
Econor 50% 400 mg/kg feed
Econor 50 % 400 mg/kg krme
Weaner
Karenca
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Ime in naslov imetnika dovoljenja za promet z zdravilom ter proizvajalec zdravila,
4.2 Indications for use, specifying the target species
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Econor 50 %
Econor 50% 400 mg/kg feed Econor 10% 2 g/kg feed
Econor 50 % 400 mg/kg krme Econor 10 % 2 g/kg krme
Econor 50% 150 mg/kg feed Econor 10% 750 mg/kg feed
Econor 50 % 150 mg/kg krme Econor 10 % 750 mg/kg krme
Pigs: Meat and offal: 1 day.
KARENCA Meso in organi: 1 dan.
The active substance in Econor, valnemulin, is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
(dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010:
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES Valnemulin hydrochloride
NAVEDBA UČINKOVIN(E) valnemulin
mg Econor 10% premix/kg feed = Dosage required (mg/kg) x 10 x bodyweight (kg)/Daily feed intake (kg)
mg Econor 10 % predmešanica/kg krme = priporočen odmerek (mg/kg) x 10 x telesna masa (kg)/količino dnevnega vnosa krme (kg)
AUTHORISATION
Odstavljenec
Incorporation of 35 mg active substance per kg feed with: Econor 10% 350 mg/kg feed
Dodajanje 35 mg učinkovine/kg krme: Econor 10 % 350 mg/kg krme
In feed use for rabbits:
Dajanje v krmni mešanici za kunce:
This dose level is effective under normal situations in the treatment of clinical signs of disease, but higher doses or longer duration of treatment may be necessary for complete elimination of infection.
Takšen odmerek je v običajnih okoliščinah učinkovit pri zdravljenju klinično izražene bolezni; za popolno eliminacijo okužbe je potreben večji odmerek zdravila ali daljši čas zdravljenja.
Econor 10%, Econor 50%: 1 kg and 25 kg aluminium-lined plastic bags.
1 kg in 25 kg z aluminijem podložene plastične vreče.
Econor 50% 50 mg/kg feed Econor 10% 250 mg/kg feed
Econor 50 % 50 mg/kg krme Econor 10 % 250 mg/kg krme
Incorporation of 25 mg active substance per kg feed with:
Dodajanje 25 mg učinkovine/kg krme:
Grower
Odmerek
Extreme care should be taken in the use of Econor in pigs of the Danish and Swedish Landrace breeds, and their crossbreeds thereof, especially in younger pigs.
Pri uporabi zdravila Econor pri pasmah danski in švedski landrace ter križancih, ki vključujejo katero od teh pasem, je treba biti zelo previden, še posebej pri mlajših prašičih.
It is important to institute treatment as early as possible in an outbreak of porcine proliferative enteropathy.
Pri izbruhu prašičje proliferativne enteropatije je pomemben čimprejšnji pričetek zdravljenja.
This dose level is effective in the treatment of clinical disease, but higher dosages or longer duration of treatment may be necessary for complete elimination of infection.
Takšen odmerek je učinkovit pri zdravljenju klinično izražene bolezni; za popolno eliminacijo okužbe pa je potreben večji odmerek zdravila ali daljši čas zdravljenja.
CONTRAINDICATIONS Do not administer the product to pigs receiving ionophores.
KONTRAINDIKACIJE Ne uporabite zdravila za uporabo v veterinarski medicini pri prašičih, ki dobivajo ionofore.
Econor 50% mg Econor 50% premix/kg feed = Dosage required (mg/kg) x 2 x bodyweight (kg)/Daily feed intake (kg).
mg Econor 50 % predmešanica/kg krme = priporočen odmerek (mg/kg) x 2 x telesna masa (kg)/količino dnevnega vnosa krme (kg)
It is important to institute treatment as early as possible in an outbreak of swine dysentery.
Pri izbruhu prašičje dizenterije je pomemben čimprejšnji pričetek zdravljenja.
Shelf life when incorporated into pelleted pig feed and protected from light and moisture: 3 weeks.
Rok uporabnosti, ko je zdravilo dodano v peletirano krmo za prašiče in zaščiteno pred svetlobo in vlago: 3 tedne.
Swine dysentery 3-4 mg/kg bodyweight/day
Ciljno 3 mg/kg telesne mase/dan
NAME OF THE VETERINARY MEDICINAL PRODUCT Econor 10% oral powder for pigs Valnemulin
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Econor 10 % peroralni prašek za prašiče valnemulin
NO ENTRY Antiinfectious agents
NI VNOSA Antiinfekti vne snovi/antibi otiki
PACKAGE LEAFLET: Econor 50% premix for medicated feed for pigs
NAVODILO ZA UPORABO Econor 50 % predmešanica za pripravo zdravilne krmne mešanice za prašiče
PACKAGE LEAFLET: Econor 10% oral powder for pigs
NAVODILO ZA UPORABO Econor 10 % peroralni prašek za prašiče
Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety during pregnancy and lactation has not been established in pigs.
S študijami pri podganah in miših niso bili dokazani teratogeni učinki; varna uporaba pri brejih in doječih svinjah ni bila dokazana.
Treatment of swine enzootic pneumonia The recommended dose of valnemulin is 10-12 mg/kg bodyweight/day for up to 3 weeks.
Priporočen odmerek valnemulina je 10-12 mg/kg telesne mase na dan, daje se do 3 tedne.
Brachyspira pilosicoli
Epizootična enteropatija kuncev
Valnemulin hydrochloride 106.5 mg/g equivalent to valnemulin 100 mg/g.
valnemulin 100 mg/g (enakovredno količini valnemulinijevega klorida 106,5 mg/g)
Daily dose calculation: Amount Econor (mg) required = Dose required (mg/kg) x pig bodyweight (kg) x 10 / daily feed intake (in kg).
Izračun dnevnega odmerka: Potrebna količina zdravila Econor (v mg) = potreben odmerek (v mg/kg) x telesna masa prašiča (v kg)
1.0-1.5 mg/kg bodyweight/day minimum of 7 days and up to 4 weeks
1,0-1,5 mg/kg telesne mase/dan
NAME OF THE VETERINARY MEDICINAL PRODUCT Econor 50% premix for medicated feed for pigs Valnemulin
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Econor 50 % predmešanica za pripravo zdravilne krmne mešanice za prašiče valnemulin
MIC of wild-type population (µg/ml)
MIC pri populaciji divjega tipa
Silica, colloidal anhydrous Isopropyl myristate Lactose
Druge sestavine: hipromeloza smukec silicijev dioksid, koloidni, brezvodni izopropilmiristat laktoza
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES Valnemulin 100 mg/g (equivalent to 106.5 mg/g valnemulin hydrochloride)
100 mg/g (enakovredno količini 106,5 mg/g valnemulinijevega klorida)
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
BESEDILO ”ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” Zdravilo shranjujte nedosegljivo otrokom.
The words “Keep out of the sight and reach of children” Keep out of the sight and reach of children.
Besedilo “zdravilo shranjujte nedosegljivo otrokom” Zdravilo shranjujte nedosegljivo otrokom.
Do not administer the product to pigs receiving ionophores.
Ne uporabite zdravila za uporabo v veterinarski medicini pri prašičih, ki dobivajo ionofore.
NAME OF THE VETERINARY MEDICINAL PRODUCT Econor 10% oral powder for pigs Valnemulin hydrochloride
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Econor 10 % peroralni prašek za prašiče valnemulinijev klorid
Adverse drug reactions following the use of Econor are mainly associated with breeds and cross breeds of Danish and/or Swedish Landrace.
NEŽELENI UČINKI Neželeni učinki po uporabi zdravila Econor so največkrat vidni pri prašičih pasme danski in/ali švedski landrace ter njihovih križancih.
Shelf life when incorporated into meal pig feed and protected from light and moisture: 3 months.
Rok uporabnosti, ko je zdravilo dodano v mleto krmo za prašiče in zaščiteno pred svetlobo in vlago: 3 mesece.
Whilst studies in rats and mice have not produced any evidence of teratogenic effect, the safety in pregnant and lactating sows and does has not been established.
S študijami pri podganah in miših niso bili dokazani teratogeni učinki; varna uporaba pri brejih in doječih svinjah ter samicah kuncev ni bila dokazana.
Name of the veterinary medicinal product Econor 10% premix for medicated feed for pigs and rabbits Valnemulin hydrochloride
Ime zdravila za uporabo v veterinarski medicini Econor 10 % predmešanica za pripravo zdravilne krmne mešanice za prašiče in kunce valnemulinijev klorid
Amount Econor 10% oral powder (mg) required = Dose required (mg/kg) x pig bodyweight (kg) x 10 / daily feed intake (kg).
Potrebna količina peroralnega praška Econor 10 % (v mg) = potreben odmerek (v mg/kg) x telesna masa prašiča (v kg) x 10/količino dnevno zaužite krme (v kg)
106.5 mg/g equivalent to valnemulin 100 mg/g.
106,5 mg/g enakovredno količini valnemulina
NAME OF THE VETERINARY MEDICINAL PRODUCT Econor 50% premix for medicated feed for pigs Valnemulin hydrochloride
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Econor 50 % predmešanica za pripravo zdravilne krmne mešanice za prašiče valnemulinijev klorid
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Nemčija Proizvajalec, odgovoren za sproščanje serij:
Econor 50% premix Sandoz GmbH Biochemiestrasse 10 6250 Kundl AUSTRIA
Econor 50 % predmešanica za pripravo zdravilne krmne mešanice Sandoz GmbH
The required quantity of Econor is thoroughly mixed with the feed in the proportion: 1 part Econor oral powder to 10 parts feed before the final addition of the remainder of the feed.
Potrebna količina zdravila Econor se dobro zmeša s krmo v razmerju 1 del peroralnega praška Econor in 10
C. STATEMENT OF THE MRLs
(μg/ml)
Animals should not receive monensin, salinomycin or narasin during or at least 5 days before or after treatment with valnemulin.
Med zdravljenjem ali vsaj 5 dni pred in 5 dni po končanem zdravljenju z valnemulinom živali ne smejo dobiti zdravil, ki vsebujejo monenzin, salinomicin ali narazin.
To be supplied only on veterinary prescription.
Pomni: nameriti je treba zvrhano zravnano žličko zdravila za uporabo v veterinarski medicini.
MRLs
Rp-Vet.
WITHDRAWAL PERIOD(S) Meat and offal: 1 day.
4.11 Karenca Meso in organi: 1 dan.
The field trial was conducted in cats at 24 veterinary practices of different geographic regions in Germany and France.
Preskušanje na terenu je bilo opravljeno na mačkah v 24 veterinarskih praksah v različnih geografskih regijah Nemčije in Francije.
The European Commission granted a marketing authorisation valid throughout the European Union, for ProMeris on 19.12.2006.
Evropska komisija je dovoljenje za promet z zdravilom ProMeris, veljavno po vsej Evropski uniji, odobrila dne 19.12.2006.
Other information about ProMeris:
Druge informacije o zdravilu ProMeris:
It is given to cats with a pre-filled spot-on pipette, a small plastic container which is already filled with the correct amount of ProMeris needed to treat one cat (ProMeris is available in 2 different sizes for various cat weights).
Daje se mačkam na kožo s predhodno napolnjeno merilno kapalko, majhno plastično cevko, ki je že napolnjena z ustrezno količino zdravila ProMeris, potrebno za zdravljenje ene mačke (zdravilo ProMeris je na voljo v 2 različnih velikostih za različno težke mačke).
Data were provided on the pharmaceutical quality, the safety of the product in cats and the safety in humans (people in contact with the product) and the environment.
Predloženi so bili podatki o farmacevtski kakovosti, varnosti zdravila za mačke ter njegovi varnosti za ljudi (za ljudi, ki pridejo v stik z zdravilom) in okolje.
When administering ProMeris, the user should not smoke, eat or drink.
Med dajanjem zdravila ProMeris je prepovedano kaditi, piti ali jesti.
This product is specifically developed for cats and should not be used in any other animal species.
To zdravilo je bilo razvito posebej za mačke in se ga ne sme uporabljati pri drugih živalskih vrstah.
ProMeris should not be used in cats less than 8 weeks old since it has not been sufficiently studied in these animals.
Zdravila ProMeris se ne sme uporabljati pri mačkah, ki so stare manj kot 8 tednov, saj pri tej skupini živali zdravilo ni bilo zadostno raziskano.
As other products of this group, ProMeris should not be used in sick animals or cats that have just recovered from illness.
Kot to velja za ostala zdravila iz te skupine zdravil, se zdravila ProMeris ne sme uporabljati pri bolnih živalih ali mačkah, ki so pravkar okrevale od bolezni.
As a precautionary measure, direct contact with the treated cat 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 zdravljeno mačko in preprečiti otrokom igranje z zdravljeno živaljo, dokler področje nanosa ni suho.
The medicine killed fleas within 24 hours after treatment and its effectiveness lasted 6 weeks.
Zdravilo ubije bolhe v 24 urah po uporabi zdravila, njegov učinek pa traja najmanj 6 tednov.
Cats from various breeds (mainly European shorthair), age groups and weight that were infested with fleas were either treated with ProMeris or with other products authorised in the EU for this indication.
Mačke različnih ras (večinoma evropske kratkodlake mačke), starostnih skupin in z različnimi telesnimi masami, ki so bile bolhave, so zdravili bodisi z zdravilom ProMeris ali z drugimi zdravili, ki so bila v EU odobrena za to indikacijo.
What is the risk associated with ProMeris?
Kakšna tveganja so povezana z zdravilom ProMeris?
ProMeris 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.
ProMeris je “ektoparaziticid”, to pomeni, da uničuje zajedalce, ki živijo na koži ali v dlaki živali, kot so denimo bolhe in klopi.
What benefit has ProMeris shown during the studies?
Kakšne koristi je zdravilo ProMeris izkazalo med raziskavami?
The effectiveness of metaflumizone against flea infestations in cats was investigated in laboratory studies and in a field trial.
Učinkovitost metaflumizona zoper bolhavost pri mačkah je bila raziskana v laboratorijskih raziskavah in preskušanju na terenu.
The Committee recommended that ProMeris be given a marketing authorisation.
Zato je priporočil, da se za zdravilo ProMeris odobri dovoljenje za promet.
The effectiveness was measured looking at the number of fleas on the cat at various times up to 2 months after application.
Učinkovitost so merili z ugotavljanjem števila živih bolh na mački ob različnih časovnih obdobjih, in sicer do 2 mesecev po uporabi zdravila.
It can also be used as part of a treatment strategy for the control of Flea Allergy Dermatitis, an allergic reaction of cats to flea bites.
Lahko se uporablja tudi kot del strategije zdravljenja za obvladovanje alergijskega dermatitisa, ki ga povzročajo bolhe, t.j.
Why has ProMeris been approved?
Zakaj je bilo zdravilo ProMeris odobreno?
ProMeris is a clear yellow to amber solution that contains metaflumizone as active substance.
ProMeris je bistra, rumena do jantarna raztopina, ki vsebuje zdravilno učinkovino metaflumizon.
There may be a change in appearance of the fur (oily appearance and clumping or spiking of hair) at the application site.
Na mestu nanosa se lahko pojavijo spremembe dlake (masten izgled, vozlanje in zlepljanje dlake).
The active substance of ProMeris, metaflumizone, interferes with the neural activity of the fleas and consequently leads to the death of these parasites.
Metaflumizon, zdravilna učinkovina v zdravilu ProMeris, ovira živčne funkcije bolh, čemur posledično sledi smrt teh zajedalcev.
If a cat licks the application area, the cat might salivate considerably for a short period.
Če mačka liže mesto nanosa, se lahko pojavi kratko obdobje prekomernega slinjenja.
What is ProMeris used for?
Za kaj se zdravilo ProMeris uporablja?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProMeris exceed the risks for the treatment and prevention of flea infestations in cats.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je mnenja, da so koristi zdravila ProMeris za zdravljenje in preprečevanje bolhavosti pri mačkah večje od z njim povezanih tveganj.
The results of the field trial showed that ProMeris is effective in the treatment and prevention of flea infestations in cats.
Rezultati preskušanj na terenu so pokazali, da je zdravilo Pro Meris učinkovito pri zdravljenju in preprečevanju bolhavosti pri mačkah.
ProMeris is used to treat and to prevent flea infestations in cats.
Zdravilo ProMeris se uporablja za zdravljenje in preprečevanje bolhavosti pri mačkah.
What is ProMeris?
Kaj je zdravilo ProMeris?
How does ProMeris work?
Kako zdravilo ProMeris deluje?
Skin should be washed and eyes should be rinsed with water, if accidental exposure occurred.
V primeru nehotenega stika je treba kožo in oči sprati z vodo.
How has ProMeris been studied?
Kako je bilo zdravilo ProMeris raziskano?
Skin contact with the pipette content should be avoided.
Pazite, da kapalka ne pride v stik s kožo.
The content of the pipette is squeezed onto the skin after parting the fur between the shoulder blades of the cat.
Mački razmaknemo dlako med lopaticama, da se prikaže koža, in na to mesto stisnemo vsebino merilne kapalke.
Once applied, it remains active for up to 6 weeks.
Učinek zdravila traja najmanj 6 tednov po njegovi uporabi.
Other pharmaceutical forms/strengths may be more appropriate for this population.
Druge farmacevtske oblike/jakosti so morda bolj primerne za to populacijo.
This medicinal product is authorised in the Member States of the EEA under the following names: {As currently approved}.
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: {Kot trenutno odobreno}.
This medicine is available as 5 mg, 10 mg, 20 mg and 40 mg chewable tablets and 10 mg, 20 mg, 40 mg and 80 mg film-coated tablets.
To zdravilo je na voljo kot 5 mg, 10, mg, 20 mg in 40 mg žvečljive tablete in 10 mg, 20 mg, 40 mg in 80 mg filmsko obložene tablete.