natgillin/translations-raw huggingface dataset:
After multiple oral doses of 2 mg spironolactone per kg for 10 consecutive days, no accumulation is observed.
10 zaporednih dni ni bilo opaziti akumulacije.
Mean Cmax of 382 µg/ l and 94 µg/ l are achieved for the primary metabolites, 7α -thiomethyl- spironolactone and canrenone, after 2 and 4 hours, respectively.
Najvišjo Cmax 382 µg/ l in 94 µg/ l dosežeta primarna metabolita, 7α- tiometil- spironolakton in kanrenon, po 2 in 4 urah.
Distribution The mean volumes of distribution (Vss) of 7α -thiomethyl-spironolactone and canrenone are approximately 153 litres and 177 litres respectively.
Distribucija Volumna distribucije (Vss) 7α- tiometil- spironolaktona in kanrenona sta približno 153 in 177 litrov.
Metabolism Spironolactone is rapidly and completely metabolised by the liver into its active metabolites, 7α - thiomethyl-spironolactone and canrenone, which are the primary metabolites in the dog.
Metabolizem Spironolakton se hitro in v celoti metabolizira v jetrih v aktivna metabolita, 7α- tiometil- spironolakton in kanrenon, ki sta primarna metabolita pri psih.
Elimination Spironolactone is mainly excreted via its metabolites.
Izločanje Spironolakton se največ izloča v obliki metabolitov.
Plasma clearance of canrenone is 1.45±0.39 l/ h/ kg and 7α -thiomethyl-spironolactone is 0.89±0.44 l/ h/ kg.
Plazemski klirens kanrenona je 1. 45±0. 39 l/ h/ kg in 7α- tiometil- spironolaktona 0. 89±0. 44 l/ h/ kg.
After oral administration of radiolabelled spironolactone to the dog, 70% of the dose is recovered in faeces and 20% in the urine.
Po peroralnem dajanju radiološko označenega spironolaktona psom so ugotovili 70% odmerka v blatu in 20% v urinu.
Beef flavouring Mannitol Sodium laurilsulfate Microcrystalline cellulose Povidone Sorbitol Talc Magnesium stearate
Aroma govedine Manitol Natrijev lavrilsulfat Mikrokristakna celuloza Povidon Sorbitol Smukec Magnezijev stearat
6.2 Incompatibilities
5/ 25 6. 2 Inkompatibilnosti
3 years as packaged for sale.
6. 3 Rok uporabnosti
Special precautions for storage
Rok uporabnosti zdravila v pakiranju za prodajo je 3 leta.
Partially used tablets should be stored in the original blister pack.
6. 4 Posebna navodila za shranjevanje
6.5 Nature and composition of immediate packaging
Deli tablet se morajo hraniti v originalnem pretisnem omotu.
Material of the primary container
6. 5 Vrsta ovojnine in vsebina
Blister packs (polyamide/ aluminium/ polyvinyl chloride/ /aluminium) in a cardboard box.
Material primarne ovojnine Pretisni omoti( poliamid/ aluminij/ polivinil klorid // aluminij) v kartonasti škatli.
Box containing 3 blisters of 10 tablets Box containing 18 blisters of 10 tablets
Velikost pakiranja Škatla s 3 pretisnimi omoti po 10 tablet Škatla z 18 pretisnimi omoti po 10 tablet
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
6. 6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
CEVA SANTE ANIMALE Z. I. la Ballastière 33500 Libourne France
CEVA SANTE ANIMALE Z. I. la Ballastière 33500 LIBOURNE Francija
EU/ 2/ 07/ 074/ 001 – 002 (10 mg tablets) EU/ 2/ 07/ 074/ 003 – 004 (40 mg tablets) EU/ 2/ 07/ 074/ 005 – 006 (80 mg tablets)
EU/ 2/ 07/ 074/ 001 – 002 EU/ 2/ 07/ 074/ 003 – 004 EU/ 2/ 07/ 074/ 005 – 006
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
6/ 25 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
7/ 25 ANNEX II
7/ 25 DODATEK II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
OR
C.
RESTRICTIONS
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE
THE
NAVEDBA
MARKETING
NAJVIŠJIH
CONDITIONS
DOVOLJENIH
RESTRICTIONS
KOLIČIN
MARKETING
ZAOSTANKOV
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK( I) DOVOLJENJ( A) ZA IZDELAVO (ODGOVORNI) ZA SPROŠČANJE SERIJE
Name and address of the manufacturer responsible for batch release
Ime in naslov izdelovalca( izdelovalcev) zdravila, odgovornega za sproščanje serije
Très le Bois F-22600 Loudeac France
Très le Bois 22600 LOUDEAC Francija
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Skladno z odločbo mora imetnik dovoljenja za promet obvestiti Evropsko komisijo o načrtih trženja zdravila.
9/ 25 ANNEX III
9/ 25 DODATEK III
11/ 25 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
11/ 25 PODATKI NA ZUNANJI OVOJNINI
Carton box labelling – 10 mg tablets
Kartonasta škatla – 10 mg tablete
PRILACTONE 10 mg tablets for dogs Spironolactone.
PRILACTONE 10 mg tablete za pse Spironolakton.
Each tablet contains 10 mg spironolactone
Ena tableta vsebuje 10 mg spironolaktona
30 tablets 180 tablets
30 tablet 180 tablet
Read the package leaflet before use.
Peroralna uporaba Pred uporabo preberite navodilo za uporabo.
{month/ year}
{mesec / leto
Store partially used tablets in the original blister pack.
Delno uporabljene tablete shranjujte v originalnem pretisnem omotu.
For animal treatment only – to be supplied only on veterinary prescription.
Samo za živali - oskrba le na podlagi veterinarskega recepta
EU/ 2/ 07/ 074/ 001 (3 blisters of 10 tablets) EU/ 2/ 07/ 074/ 002 (18 blisters of 10 tablets)
EU/ 2/ 07/ 074/ 001 (3 pretisni omoti z 10 tabletami) EU/ 2/ 07/ 074/ 002 (18 pretisnih omotov z 10 tabletami)
13/ 25 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
13/ 25 PODATKI NA ZUNANJI OVOJNINI
Carton box labelling – 40 mg tablets
Kartonasta škatla – 40 mg tablete
PRILACTONE 40 mg tablets for dogs Spironolactone.
PRILACTONEP 40 mg tablete za pse Spironolaktone.
Each tablet contains 40 mg spironolactone.
Ena tableta vsebuje 40 mg spironolaktona.
{month/ year}
{mesec / leto}
For animal treatment only – to be supplied only on veterinary prescription.
Samo za živali – oskrba le na veterinarski recept.
EU/ 2/ 07/ 074/ 003 (3 blisters of 10 tablets) EU/ 2/ 07/ 074/ 004 (18 blisters of 10 tablets)
EU/ 2/ 07/ 074/ 003 (3 pretisni omoti z 10 tabletami EU/ 2/ 07/ 074/ 004 (18 pretisnih omotov z 10 tabletami)
15/ 25 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
15/ 25 PODATKI NA ZUNANJI OVOJNINI
Carton box labelling – 80 mg tablets
Kartonasta škatla 80 mg tablete
PRILACTONE 80 mg tablets for dogs Spironolactone.
Spironolakton.
Each tablet contains 80 mg spironolactone.
Ena tableta vsebuje 80 mg spironolaktona
For animal treatment only - to be supplied only on veterinary prescription.
Samo za živali – oskrba le na veterinarski recept.
Keep out of the reach and sight of children.
Zdravilo shranjujte izven dosega otrok.
EU/ 2/ 07/ 074/ 005 (3 blisters of 10 tablets) EU/ 2/ 07/ 074/ 006 18 blisters of 10 tablets
EU/ 2/ 07/ 074/ 005 (3 pretisni omoti z 10 tabletami) EU/ 2/ 07/ 074/ 006 (18 pretisnih omotov z 10 tabletami)
17/ 25 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
17/ 25 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Blister foil of 10 tablets
Pretisni omot z 10 tabletami
PRILACTONE 10 mg tablets Spironolactone
PRILACTONE 10 mg tablete Spironolakton
Lot:
Lot: {xxxxx}
18/ 25 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
18/ 25 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU Pretisni omot z 10 tabletami
PRILACTONE 40 mg tablets Spironolactone
Spironolakton
19/ 25 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
19/ 25 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
PRILACTONE 80 mg tablets Spironolactone
PRILACTONE 80 mg tablete Spironolakton
Lot:
Lot: {xxxxx}:
21/ 25 PACKAGE LEAFLET
21/ 25 NAVODILO ZA UPORABO:
PRILACTONE 10 mg tablets for dogs PRILACTONE 40 mg tablets for dogs PRILACTONE 80 mg tablets for dogs
PRILACTONEP 10 mg tablete za pse PRILACTONEP 40 mg tablete za pse PRILACTONEP 80 mg tablete za pse
CEVA SANTE ANIMALE Z. I. la Ballastière 33500 Libourne France Tel: + 33 (0) 5 57 55 40 40 e-mail: contact@ceva. com
CEVA SANTE ANIMALE Z. I. la Ballastière 33500 LIBOURNE Francija Tel: + 33 (0) 5 57 55 40 40 Fax: + 33 (0) 5 57 55 40 06 e- mail: prilactone@ ceva. com
Très le Bois 22600 Loudéac France
Très le Bois 22600 LOUDEAC Francija
10 mg 40 mg 80 mg
spironolakton 10 mg spironolakton 40 mg sspironolakton 80 mg
Excipients include beef flavouring.
Pomožne snovi vsebujejo aromo govedine.
PRILACTONE tablets are used in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.
Zmanjšanje kardiovaskularnih poškodb pri kongestivni odpovedi srca povzročeni zaradi valvularne regurgitacije pri psihv kombinaciji s standardno terapijo, ki vključuje diuretično podporo, če je potrebno.
Do not use in pregnant or lactating animals or in animals used for, or intended for use in breeding.
Ne uporabite pri vzrejnih živalih ali pri živalih, ki so namenjene za vzrejo.
Do not use in conjunction with non-steroidal anti-inflammatory drugs (NSAIDs) in dogs with renal insufficiency (kidney impairment/ dysfunction).
Ne uporabljajte skupaj z NSAID (nesteroidno protivnetno zdravilo) pri psih z insuficienco ledvic.
A reversible prostatic atrophy (reduction in size) is often observed in entire male dogs.
Reverzibilna atrofija prostate (redukcija v velikosti) je pogosto opažena pri nekastriranih samcih.
Partially used tablets should be stored in the original blister pack.
Delno uporabljene tablete shranjujte v originalnem pretisnem omotu
Do not use after the expiry date (EXP) which is stated on the carton and blister label.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti (“ EXP ”), navedenega na ovojnini..
Monitoring of their renal function and plasma potassium levels is recommended before initiation and during treatment with combined therapy (see Contraindications).
(glej 4. 3).
As spironolactone has an antiandrogenic effect (acts against male hormones), it is not recommended to administer the product to growing dogs.
Ker ima spironolakton antiandrogen učinek, ni priporočljiva uporaba zdravila pri rastočih pseh.
As spironolactone undergoes extensive hepatic (liver) biotransformation, care should be taken when using the product in dogs with liver dysfunction.
Spironolakton lahko povzroči indukcijo in inhibicijo citokrom P450 encimov in lahko vpliva na metabolizem drugih zdravil, ki uporabljajo te metabolne poti.
Interactions In clinical studies, PRILACTONE was co-administered with furosemide and pimobendan without evidence of associated adverse reactions.
Medsebojno delovanje z drugimi zdravili in druge oblike interakcij V kliničnih študijah je bil PRILACTONE apliciran v kombinaciji z furosemidi in pimobendanom brez očitnih škodljivih učinkov.
As the therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both digoxin and spironolactone.
Ker je terapevtski indeks digoksina zelo ozek, je priporočljivo spremljati stanje živali, ki je zdravljena z digoksinom in spironolaktonom.
The administration of either deoxycorticosterone or NSAIDs with spironolactone may lead to a moderate reduction of the natriuretic effects (reduction of urinary sodium excretion) of spironolactone.
Aplikacija deoxykortikosteronov ali NSAID( nesteroidno protivnetno zdravilo) s spironolaktonom lahko povzroči zmerno znižanje natridiuretičnega učinka spironolaktona (zmanjšano izločanje natrija z urinom)
(See Special precautions for use in animals).
Hkratna aplikacija spironolaktona z inhibitorji ACE in drugimi s kalijem revnimi zdravili (kot blokatorji angiotenzinskih receptorjev, ß- blokatorji, blokatorji kalcijevih kanalov, itd..) lahko privede do hiperkaliemije (glej 4. 5).
24/ 25 Overdose After administration of up to 10 times the recommended dose (20 mg/ kg) to healthy dogs, dose- dependent adverse effects were noted (see Adverse Reactions).
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po administraciji preko 10- kratnega priporočenega odmerka (20 mg/ kg) zdravemu psu, so opazili neželene učinke odvisne od odmerka, kot je opisano v poglavju 4. 6.
Symptomatic treatment, e. g., fluid therapy, should be provided.
Priporočljiva je simptomatska terapija kot so infuzije..
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..
PRILACTONE tablets are supplied in blister packs with 30 or 180 tablets per pack.
PRILACTONE tablete so pakirane v pretisnem omotu s 30 ali 180 tabletami na eno pakiranje.
Pharmacodynamic properties Spironolactone and its active metabolites (including 7α -thiomethyl-spironolactone and canrenone) act as specific antagonists of aldosterone, and exert their effects by binding competitively to the mineralocorticoid receptor located in the kidneys, heart and blood vessels.
Farmakodinamične lastnosti Spironolakton in njegovi aktivni metaboliti (vključno z 7α- tiometil- spironolaktonom in kanrenonom) delujejo kot specifični antagonisti aldosterona, ki svoje učinke kažejo s kompetitivno vezavo na mineralokortikoidne receptorje v ledvicah, srcu in krvnih žilah.
When used in combination with ACE-inhibitors, spironolactone may counteract the effects of “ aldosterone escape”.
Rahel dvig nivoja aldosterona v krvi je lahko opažen pri zdravljenih živalih.. aktivacije povratnih mehanizmov brez neželenih kliničnih posledic.
A slight increase in aldosterone blood levels may be observed in animals on treatment.
To je posledica
Profender is an antiparasitic medicine that contains two active substances, emodepside and praziquantel.
Profender je protizajedalsko zdravilo, ki vsebuje dve zdravilni učinkovini, emodepsid in prazikvantel.
Profender is available as a clear yellow to brownish solution for use on cats, and as modified release tablets for dogs.
Zdravilo Profender je na voljo kot bistra, rumena do rjavkasta raztopina za uporabo pri mačkah, kot tableta s prilagojenim sproščanjem pa za uporabo pri psih.
Modified-release means that the tablets release their active substances over a few hours.
Prilagojeno sproščanje pomeni, da se zdravilna učinkovina sprosti iz tablete v nekaj urah.
Profender solution is packed as spot-on pipettes, which are already filled with the correct amount of Profender needed to treat one cat (3 size of pipettes for different cat weights) and as a multidose bottle for use only in a veterinary surgery, where the vet will measure the exact volume of Profender needed for each cat before application.
Zdravilo Profender je pakirano v kapalkah za kožni nanos, ki so že napolnjene z ustrezno količino zdravila, potrebnega za zdravljenje ene mačke (tri različne velikosti kapalk za različno težke mačke) in kot večodmerna steklenička za uporabo pri veterinarskih kirurških posegih, kjer veterinar pred posegom odmeri natančno količino zdravila Profender, ki je potrebna za posamezno mačko.
Profender tablets are bone-shaped, and available in three different strengths to cover a range of dog weights (small, medium or large dogs).
Tablete Profender so v obliki kosti in so na voljo v treh različnih jakostih, ki ustrezajo različno težkim psom (majhni, srednje veliki in veliki psi).
The tablets have a break-line.
Tablete imajo zarezo za prepolovitev.
What is Profender used for?
Za kaj se zdravilo Profender uporablja?
Profender is used to treat cats and dogs that have, or are at risk of catching, “ mixed” (caused by more than one parasite) parasitic infections.
Zdravilo Profender se uporablja za zdravljenje mačk in psov, ki imajo „ mešano “ (ki jo povzroča več zajedalcev) zajedalsko okužbo ali pri katerih obstaja tveganje, da se okužijo.
Profender works for infections caused by certain types of roundworms and tapeworms.
Zdravilo Profender deluje proti okužbam z določenimi vrstami glist in trakulj.
Profender is given as a single treatment.
Zdravilo Profender se daje samo enkrat.
The appropriate quantity of Profender (either the contents of one full pipette or the volume measured by the vet) is applied onto the cat ’ s skin, after parting the fur on the back of its neck at the base of its head.
Ustrezno količino zdravila Profender (vsebino ene polne kapalke ali količino, ki jo odmeri veterinar) je treba nanesti mački na zatilje in sicer je treba razmakniti dlako, da je vidna koža.
Dogs are treated using Profender modified-release tablets, which are given by mouth when the dog is fasting.
Za zdravljenje psov se uporabljajo tablete zdravila Profender s spremenjenim sproščanjem, ki jih je treba dati psu peroralno in na tešče.
The correct number of tablets or half tablets to use is calculated based on the dog’ s weight.
Število potrebnih tablet ali polovičk tablet se določi na podlagi telesne mase psa.
The two active substances in Profender interact with different parts of the parasites systems.
Zdravilni učinkovini v zdravilu Profender vplivata na različne dele zajedalskega sistema.
Praziquantel damages the skin-like outer layer of tapeworms, leading to their paralysis and death.
Emodepsid deluje na nekatere določene receptorje v živčnem sistemu gliste, kar povzroči
Reproduction is authorised provided the source is acknowledged How has Profender been studied?
Reproduction is authorised provided the source is acknowledged paralizo in pogin zajedalca.
The effectiveness of each of the products against the specified roundworms and tapeworms was investigated in both laboratory studies and in large field studies (one for the spot-on for cats and another for the tablets for dogs) carried out at several different places across Europe.
Učinkovitost vsake učinkovine proti določenim glistam in trakuljam je bila preučena v laboratorijskih študijah in obsežnih študijah na terenu (ena za kožni nanos pri mačkah in druga za tablete pri psih).
In each of the field studies, animals of various breeds, age groups and different weights that were naturally infected with parasitic gastrointestinal roundworms or tapeworms, were treated either with Profender or another medicine which is authorised in the European Union for this indication.
V vsaki od študij na terenu so bile živali različnih pasem, starosti in telesne mase, ki so bile okužene z zajedalskimi gastrointestinalnimi glistami in trakuljami, zdravljene bodisi z zdravilom Profender ali drugim zdravilom, ki je v Evropski uniji odobreno za to indikacijo.
The comparator was selamectin in cats, and milbemycin oxime and praziquantel in dogs.
Primerjalne učinkovine so bile selamektin pri mačkah ter milbemicin oksim in prazikvantel pri psih.
The effectiveness was measured by looking at the number of worm eggs or parts of tapeworms passed out in the animal’ s faeces after treatment.
Učinkovitost je bila merjena z ugotavljanjem števila zajedalskih jajčec ali delov trakulje, izločenih z blatom po zdravljenju.
What benefit has Profender shown during the studies?
Kakšne koristi je zdravilo Profender izkazalo med študijami?
The results from the laboratory studies and from the field studies, in both cats and dogs, showed that Profender is as effective as the comparator medicine.
Rezultati laboratorijskih in terenskih študij so pokazali, da je zdravilo Profender pri mačkah in pri psih enako učinkovito kot primerjalno zdravilo.
Over 90% of cats and 99% of dogs have no roundworm or tapeworm infection after treatment with Profender.
Več kot 90% mačk in 99% psov po zdravljenju z zdravilom Profender ni bilo več okuženih z glistami ali trakuljami.
What is the risk associated with Profender?
Kakšna tveganja so povezana z zdravilom Profender?
In cats, in very rare cases, the cat might salivate or vomit after treatment.
V zelo redkih primerih se lahko pri mačkah pojavi slinjenje ali bruhanje.
This is thought to occur as a result of the cat licking the application site straight after treatment.
Zdi se, da se to zgodi, če mačka takoj po nanosu poliže mesto nanosa.
In very rare cases there might also be some temporary itchiness, inflammation or hair loss at the place where the product has been applied to the cat ’ s skin.
Zelo redko se lahko na mestu nanosa zdravila pojavi prehodno srbenje, vnetje ali izpadanje dlak.
No side effects have been reported in dogs.
Pri psih stranski učinki niso bili opaženi.
Profender should not be used in young animals (cats under 8 weeks of age or weighing less than 0.5 kg, or puppies under 12 weeks of age or weighing less than 1 kg).
Zdravilo Profender se ne sme uporabljati pri mladičih (mačkah, mlajših od 8 tednov ali lažjih od 0, 5 kg, ali psih, mlajših od 12 tednov ali lažjih od 1 kg).
As with other products of this type, Profender should be used on sick or ill cats or dogs only after a risk-benefit assessment by the vet.
Kot pri drugih podobnih zdravilih se tudi zdravilo Profender pri bolnih in oslabljenih živalih uporablja le v skladu z oceno razmerja med koristmi in tveganji.
Profender should not be allowed to enter surface water, as it may be harmful for aquatic organisms.
Zdravilo Profender ne sme priti v vodotoke, ker je lahko nevarno za vodne organizme.
Spot-on for Cats:
Raztopina za kožni nanos za mačke:
As a precautionary measure, skin contact with the pipette contents should be avoided and animals should not be stroked, groomed or allow to groom each other, until the application site is dry.
Kot previdnostni ukrep je treba preprečiti stik kože z vsebino kapalke, živali pa se ne smejo božati ali negovati, niti jim dovoliti, da se ljubkujejo med seboj, dokler se mesto nanosa ne posuši.
Frequent users of the product (for example, professional cat breeders) and women who are or could be pregnant, are advised to wear disposable gloves when using the product.
Ljudje, ki pogosto rokujejo s tem zdravilom (na primer, rejci mačk) ali ženske, ki so ali bi lahko bile noseče, naj pri rokovanju z zdravilom uporabljajo rokavice za enkratno uporabo.
When administering Profender, users should not smoke, eat or drink, and should wash their hands thoroughly after use.
Med nanašanjem zdravila Profender uporabnik ne sme kaditi, jesti ali piti, po uporabi pa si mora temeljito umiti roke.
The solvent in Profender may stain certain materials including leather, fabrics, plastics and finished surfaces, so contact between the product and such surfaces should be avoided.
Topilo v zdravilu Profender lahko pusti madeže na nekaterih materialih, vključno z usnjem, tkaninah, plastiki in lakiranih površinah, zato preprečite stik zdravila s takimi površinami.
Tablets for Dogs:
Tablete za pse:
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Profender exceed the risks for cats or dogs suffering from, or at risk from, mixed parasitic infections, and recommended that Profender be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sklenil, da koristi zdravila Profender pri mačkah in psih, ki imajo ali pri katerih obstaja tveganje za mešane zajedalske okužbe, presegajo morebitna tveganja, zato je priporočil, da se za zdravilo Profender odobri dovoljenje za promet.
The benefit- risk balance may be found in module 6 of this EPAR.
Razmerje med koristmi in tveganji je na voljo v modulu 6 tega evropskega javnega poročila o oceni zdravila (EPAR).
The European Commission granted a marketing authorisation valid throughout the European Union for Profender to Bayer HealthCare AG (now Bayer Animal Health GmbH) on 27 July 2005.
Evropska komisija je dovoljenje za promet z zdravilom Profender, veljavno po vsej Evropski uniji, odobrila družbi Bayer HealthCare AG (zdaj Bayer Animal Health GmbH) dne 27. julija 2005.
Profender spot-on solution
Profender, kožne kapljice za male mačke
85.8 mg/ ml
85, 8 mg/ ml prazikvantela & 21, 4 mg/ ml emodepsida
Pipette (PP)
Polipropilenska pipeta z navojno zaporko
21.4 mg/ ml emodepside
Navedba ni smiselna
20 pipettes
20 pipet
40 pipettes
40 pipet
Profender spot-on solution
Profender, kožne kapljice za srednje velike mačke
Page 1/ 5 EU Number
EU številka
Profender spot-on solution
Profender, kožne
Pipette (PP)
Polipropilenska
for medium cats
kapljice za
praziquantel &
prazikvantela &
with screw
raztopina