natgillin/translations-raw huggingface dataset:
Lactose Monohydrate Microcrystalline Cellulose Chartor Hickory Smoke Flavour Hydroxypropyl Cellulose Croscarmellose Sodium Magnesium Stearate Caramel E150d Silica, colloidal anhydrous Iron Oxides
laktoza monohidrat celuloza, mikrokristalna Chartor dimni hikori okus hidroksipropilceluloza natrijev karmelozat, premreženi magnezijev stearat amoniakalno sulfitni karamel E150d silicijev dioksid, koloidni železovi oksidi
3 years 5/ 33 Half tablets should be returned to the original market container and may be stored for up to 7 days
3 leta Razpolovljene tablete vrnjene v originalno embalažo lahko hranite največ 7 dni.
Previcox tablets are supplied in carton boxes containing blisters (transparent PVC / aluminium foil and paper backing).
V škatlah so Previcox tablete v pretisnih omotih (prozorni PVC/ aluminijasta folija in papirna opora).
The chewable tablets are available in the following pack sizes:
5/ 31 Žvečljive tablete so na voljo v naslednjih pakiranjih:
1 carton box containing one blister of 10 tablets 1 carton box containing three blisters of 10 tablets each 1 carton box containing eighteen blisters of 10 tablets each
1 škatla z enim pretisnim omotom z 10 tabletami 1 škatla s tremi pretisnimi omoti, vsak z 10 tabletami 1 škatla z osemnajstimi pretisnimi omoti, vsak z 10 tabletami
MERIAL 29 avenue Tony Garnier FR-69007 Lyon France.
MERIAL 29 avenue Tony Garnier FR- 69007 Lyon Francija
17/ 10/ 2008
{MM/ LLLL} ali < mesec LLLL >
6/ 33 PROHIBITION OF SALE, SUPPLY AND/ OR USE
PREPOVED PRODAJE, OSKRBE IN/ ALI UPORABE
7/ 33 1.
6/ 31 1.
Previcox 8.2 mg/ g oral paste for horses.
Previcox 8. 2 mg/ g peroralna pasta za konje
Each syringe contains 7.32 g of paste and delivers:
Vsaka brizga za peroralno dajanje s po 7, 32 g paste in nosilca vsebuje:
Firocoxib 8.2 mg/ g
Firokoksib 8, 2 mg/ g
For a full list of excipients, see section 6.1.
Za celoten seznam pomožnih snovi, glejte poglavje 6. 1
8/ 33 Special precautions to be taken by the person administering the veterinary medicinal product to animals
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega zaužitja zdravila se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
Avoid contact with eyes and skin.
7/ 31 Izogibajte se stiku z očmi in kožo.
To administer Previcox at the dose of 0.1 mg firocoxib/ kg, set the syringe plunger to the appropriate dose division for the horse’ s weight.
Za aplikacijo zdravila Previcox v odmerku 0, 1 mg firokoksiba/ kg telesne mase, nastavite bat brizge na primeren razdelek odmerka, glede na telesno maso konja.
9/ 33 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4. 10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno)
At high dosages and prolonged treatment (3 times the recommended dose for 42 consecutive days and 2.5 times the recommended dose for 92 consecutive days administered once daily) mild to moderate renal lesions were observed.
8/ 31 V velikih odmerkih in pri podaljšanem zdravljenju (3- kratni priporočeni odmerek 42 zaporednih dni in 2, 5- kratni priporočeni odmerek 92 zaporednih dni enkrat dnevno), so opazili blage do zmerne poškodbe ledvic.
COX-2 is also thought to be involved in ovulation, implantation and closure of the ductus arteriosus, and central nervous system functions (fever induction, pain perception, and cognitive function). “ In “ in vitro” equine whole blood assays, firocoxib exhibits 222 to 643 fold selectivity for COX-2 over COX-1.
V » in vitro « poskusih s celokupno krvjo konjev, firokoksib izraža 222 do 643- krat večjo selektivnost za COX- 2 kot za COX- 1. koncentracija firokoksiba, ki je potrebna, da se inhibira 50% encima COX- 2 (t. j.
The concentration of firocoxib required to inhibit 50% of the COX-2 enzyme (i. e., the IC50) is 0.0369 to 0.12 µM, whereas the IC50 for COX-1 is 20.14 to 33.1 µM.
IC50) je 0, 0369 – 0, 12 µM, medtem pa je IC50 za COX- 1 enaka 20, 14 – 33, 1 µM.
6.1 List of excipients
6. 1.
10/ 33 Silica, colloidal anhydrous Magnesium carbonate, heavy Macrogol 300
Seznam pomožnih snovi titanov dioksid (E 171) gliceriltriacetat silicijev dioksid, koloidni, brezvodni magnezijev subkarbonat, težki makrogol 300
6.3 Shelf life
9/ 31 6. 3 Rok uporabnosti
10/ 04/ 2008
{MM/ LLLL}
11/ 33 PROHIBITION OF SALE, SUPPLY AND/ OR USE
PREPOVED PRODAJE, OSKRBE IN/ ALI UPORABE
12/ 33 ANNEX II
10/ 31 DODATEK II
13/ 33 A.
11/ 31 A.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA SPROŠČANJE SERIJE
Firocoxib is included in Annex I of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
Firokoksib je vključen v Dodatek III Uredbe Sveta (ES) No 2377/ 90 kot je navedeno v tabeli:
Equidae
mišice
Muscle Fat Liver Kidney
MRL veljajo do 1. 7. 2007
14/ 33 ANNEX III
12/ 31 DODATEK III
15/ 33 A.
13/ 31 A.
16/ 33 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
14/ 31 PODATKI NA ZUNANJI OVOJNINI
10 tablets 30 tablets 180 tablets
10 tablet 30 tablet 180 tablet
Peri-operative pain management.
Peri- operativno obvladovanje bolečine.
METHOD AND ROUTE(S) OF ADMINISTRATION
NAČIN IN POT( I) UPORABE IN DAJANJA
17/ 33 10.
15/ 31 10.
EXP {month/ year} Half tablets should be returned to the original market container and may be stored for up to 7 days
EXP {mesec/ leto} Razpolovljene tablete vrnjene v originalno embalažo lahko hranite največ sedem dni.
MERIAL, 29 avenue Tony Garnier, FR-69007 Lyon, France
MERIAL, 29 avenue Tony Garnier, FR- 69007 Lyon, Francija
EU/ 2/ 04/ 045/ 001 10 tablets EU/ 2/ 04/ 045/ 002 30 tablets EU/ 2/ 04/ 045/ 005 180 tablets
EU/ 2/ 04/ 045/ 001 10 tablet EU/ 2/ 04/ 045/ 002 30 tablet EU/ 2/ 04/ 045/ 005 180 tablet
18/ 33 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
16/ 31 PODATKI NA ZUNANJI OVOJNINI
19/ 33 10.
17/ 31 10.
EU/ 2/ 04/ 045/ 003 10 tablets EU/ 2/ 04/ 045/ 004 30 tablets EU/ 2/ 04/ 045/ 006 180 tablets
EU/ 2/ 04/ 045/ 003 10 tablet EU/ 2/ 04/ 045/ 004 30 tablet EU/ 2/ 04/ 045/ 006 180 tablet
20/ 33 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
18/ 31 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
21/ 33 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
19/ 31 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Previcox 227 mg chewable tablets Firocoxib
Previcox 227 mg žvečljive tablete Firokoksib
22/ 33 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
20/ 31 PODATKI NA ZUNANJI OVOJNINI
EXP {month/ year} Once broached, use within 3 months.
EXP {mesec/ leto}
24/ 33 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
22/ 31 PODATKI, KI OVOJNINAH
Syringe labelling
OZNAČEVANJE BRIZGE
Previcox 8.2 mg/ g oral paste for horses
Previcox 8. 2 mg/ g peroralna pasta za konje
Firocoxib 8.2 mg/ g
Firokoksib 8. 2 mg/ g
7.32 g of oral paste
7. 32 g peroralne paste.
25/ 33 B.
23/ 31 B.
26/ 33 PACKAGE LEAFLET Previcox 57 mg chewable tablets for dogs Previcox 227 mg chewable tablets for dogs
24/ 31 NAVODILO ZA UPORABO Previcox 57 mg žvečljive tablete za pse Previcox 227 mg žvečljive tablete za pse
Manufacturer for the batch release:
Imetnik dovoljenja za izdelavo zdravila, odgovoren za sprostitev serije:
MERIAL, 4 Chemin du Calquet, FR-31300 Toulouse, France
MERIAL, 4 Chemin du Calquet – FR- 31300 Toulouse, Francija
Firocoxib 57 mg Firocoxib 227 mg
57 mg firokoksib 227 mg firokoksib
Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAID).
Ne uporabite sočasno s kortikosteroidi ali drugimi nesteroidnimi protivnetnimi zdravili (NSAID).
27/ 33 If adverse reactions like vomiting, repeated diarrhoea, faecal occult blood, sudden weight loss, anorexia, lethargy, degradation of renal or hepatic biochemistry parameters occur, use of the product should be stopped and the advice of a veterinarian should be sought.
25/ 31 Če se pojavijo stranski učinki kot je bruhanje, ponavljajoča se driska, kri v blatu, nenadna izguba telesne mase, anoreksija, letargičnost, spremenjene vrednosti biokemičnih parametrov ledvic ali jeter, takoj prenehajte z uporabo tega zdravila in poiščite veterinarsko pomoč.
5 mg/ kg once daily.
Enkrat dnevno 5 mg/ kg.
For the reduction of post-operative pain and inflammation, the animals can be dosed starting approximately 2 hours before surgery for up to 3 consecutive days as needed.
Za zmanjšanje post- operativne bolečine in vnetja lahko damo živalim prvi odmerek približno 2 uri pred operativnim posegom in po potrebi nadaljujemo zdravljenje še do 3 zaporedne dni.
Number of chewable tablets by size Body weight (kg)
Število žvečljivih tablet glede na Telesna masa (kg) 3 – 5, 5 5, 6 – 10 10, 1 – 15 15, 1 – 22 22, 1 – 45 45, 1 – 68 68, 1 – 90
1
velikost 57 mg 0, 5 1 1, 5
0.5 1 1.5 2
227 mg 0, 5 1 1, 5 2
In order to protect from moisture, store in the original package.
26/ 31 Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki.
Do not use after the expiry date stated on the label Half tablets should be returned to the original market container and may be stored for up to 7 days
Razpolovljene tablete vrnjene v originalno embalažo lahko hranite največ 7 dni.
Appropriate laboratory testing is recommended prior to treatment in order to detect subclinical (asymptomatic) renal or hepatic disorders that may predispose to adverse effects.
Ne dajajte živalim, ki so mlajše od 10 tednov.
Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there is a risk of increased renal toxicity.
Če se pojavijo stranski učinki, je zdravljenje potrebno prekiniti in se posvetovati z veterinarjem.
Concurrent administration of potentially nephrotoxic drugs should be avoided.
Izogibajte se uporabi zdravila pri živalih, ki so dehidrirane, hipovolemične ali imajo nizek krvni tlak, ker v teh primerih obstaja potencialna nevarnost za povečano toksičnost za ledvice.
Use this product under strict veterinary monitoring where there is a risk of gastro-intestinal bleeding, or if the animal previously displayed intolerance to NSAIDs.
Pri uporabi zdravila pri živalih, kjer obstaja tveganje za pojav želodčno- črevesnih krvavitev ali gre za živali z znano preobčutljivostjo na druga NSAID, morajo biti te živali pod strogim veterinarskim nadzorom.
Concurrent administration of potentially nephrotoxic drugs should be avoided as there might be an increased risk for renal toxicity.
Sočasno zdravljenje z molekulami, ki vplivajo na pretok skozi ledvice n. pr. diuretiki ali inhibitorji angiotenzin konvertaze( ACE), mora biti pod strogim veterinarskim nadzorom., ker obstaja povečana nevarnost toksičnega vpliva na ledvice.
Wash hands after use of the product.
Nosečnice naj se izogibajo stika z zdravilom, oziroma naj pri dajanju zdravila nosijo zaščitne rokavice.
14.
27/ 31 14.
Firocoxib is a non-steroidal anti-inflammatory drug (NSAID) that acts by selective inhibition of cyclooxygenase-2 (COX-2) – mediated prostaglandin synthesis.
Firokoksib je nesteroidno protivnetno zdravilo (NSAID), selektivno zavira delovanje ciklooksigenaze - 2 (COX- 2) v sintezi prostaglandinov.
COX-2 is the isoform of the enzyme
COX- 2 izoformna oblika encima je po nekaterih ugotovitvah prvotno odgovorna za sintezo prostanoidnih mediatorjev bolečine, vnetja in povišane telesne temperature.
In in-vitro canine whole blood assays, firocoxib exhibited approximately 380-fold selectivity for COX-2 over COX-1.
Raziskave krvi pri psu in vitro so pokazale, da firokoksib 380 krat bolj selektivno deluje na COX- 2 kot na COX- 1.
The chewable tablets are available in the following pack sizes:
Žvečljive tablete so na voljo v naslednjih pakiranjih:
30/ 33 PACKAGE LEAFLET Previcox 8.2 mg/ g oral paste for horses
28/ 31 NAVODILO ZA UPORABO Previcox 8. 2 mg/ g peroralna pasta za konje
Lesions (erosion/ ulceration) of the oral mucosa and of the skin around the mouth may occasionally be observed in treated animals.
Pri zdravljenih živalih se občasno pojavijo poškodbe (erozije/ ulkusi) na ustni sluznici in na koži okrog ust.
8.
29/ 31 8.
0.1 mg firocoxib per kg bodyweight, once daily for up to 14 days.
0. 1 mg firokoksiba na kg telesne mase, enkrat dnevno največ 14 dni.
31/ 33 Oral use.
Peroralna uporaba.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and a treatment-free period with such products should therefore be observed.
30/ 31 Predhodno zdravljenje z drugimi protivnetnimi snovmi se lahko odraža v dodatnih ali povečanih neželenih učinkih, zato je potreben čas, ko ne zdravimo s takimi pripravki.
32/ 33 Concomitant treatment with molecules displaying action on renal flow (e. g. diuretics) should be subject to clinical monitoring.
Pri sočasnem zdravljenju z učinkovinami, ki vplivajo na delovanje ledvic (npr. diuretiki), je potrebno nadzorovati delovanje le- teh.
PRILACTONE is used in combination with ‘ standard therapy’ (other heart medicines, including diuretic support where necessary).
Zdravilo PRILACTONE se uporablja v kombinaciji s „ standardnim zdravljenjem “ (drugimi zdravili za srce, vključno z diuretično podporo, če je ta potrebna).
The dose to use is 2 mg per kilogram of the dog’ s body weight.
Pri tem se uporabi odmerek, ki znaša 2 mg na kilogram telesne mase psa.
The appropriate number of tablets, half tablets or quarter tablets to give according to the dog’ s size is given in the Package Leaflet.
Ustrezno število tablet, polovičk tablet ali četrtink tablet, ki jih morate psu dati glede njegovo velikost, je podano v Navodilu za uporabo.
PRILACTONE has been studied in the laboratory, as well as in three studies in dogs with heart valve diseases, which were treated in various veterinary practices or clinics across Europe (‘ clinical studies‘).
Zdravilo PRILACTONE so raziskovali v laboratoriju, kakor tudi v treh študijah pri psih z boleznimi srčnih zaklopk, ki so jih zdravili v različnih veterinarskih praksah ali klinikah po Evropi („ klinične študije “).
In these clinical studies, the animal owners gave either PRILACTONE tablets or placebo (dummy tablets without any active ingredient) to their dogs, once daily, at a dose of 2 mg/ kg with food.
V teh kliničnih študijah so lastniki svojim psom dajali bodisi tablete zdravila PRILACTONE ali pa placebo (tablete brez zdravilne učinkovine) enkrat dnevno v odmerku 2 mg/ kg skupaj s hrano.
All dogs also received ‘ standard therapy’ (generally another medicine
Zdravljenje je trajalo do 15 mesecev.
Treatment continued for up to 15 months.
(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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kakšne koristi je zdravilo PRILACTONE izkazalo med študijami?
The results of the studies showed that dogs with congestive heart failure caused by faulty heart valves that were given PRILACTONE tablets in addition to another heart medicine (‘ standard therapy’), had a longer survival time than the dogs that received the standard therapy plus placebo tablets.
Rezultati študij so pokazali, da so psi s kongestivno odpovedjo srca zaradi okvarjenih srčnih zaklopk, ki so prejemali tablete zdravila PRILACTONE istočasno z drugim zdravilom za srce („ standardno zdravljenje “), imeli daljši čas preživetja kot psi, ki so prejemali standardno zdravljenje in tablete placeba.
In a long term study, the dogs treated with PRILACTONE also showed less deterioration of their heart disease compared to the dogs which were treated only with ‘ standard therapy’.
Pri dolgotrajni študiji se je prav tako manj poslabšalo stanje bolezni srca pri psih, ki so jih zdravili z zdravilom PRILACTONE, kot pri psih, ki so jih zdravili le s „ standardnim zdravljenjem “.
Target Route of species administration
Ciljne živalske vrste
Packaging
Poti dajanja
Blister ((Polyamide/ Alu/ PVC)/ Alu)
Pretisni omot ((Poliamid/ Alu/ PVC) / Alu)
N/ A
navedba ni smiselna
180 tablets N/ A
180 tablet
30 tablets N/ A
30 tablet navedba ni smiselna
180 tablets N/ A
180 tablet navedba ni smiselna
PRILACTONE 10 mg tablets for dogs PRILACTONE 40 mg tablets for dogs PRILACTONE 80 mg tablets for dogs
PRILACTONE 10 mg tablete za pse PRILACTONE 40 mg tablete za pse PRILACTONE 80 mg tablete za pse
For a full list of excipients, see
Za celoten seznam pomožnih snovi,
section 6.1.
glejte poglavje 6. 1.
White, with a slight brownish mottling, bisected oval tablet of 10 mm length.
Bela, z rjavkasto prevleko, na pol deljiva ovalna tableta dolžine 10 mm.
White, with a slight brownish mottling, oval tablet of 17 mm length with three parallel break-lines.
Bela, z rjavkasto prevleko, ovalna tableta dolžine 17 mm s tremi paralelnimi zarezami.
White, with a slight brownish mottling, oval tablet of 20 mm length with three parallel break-lines.
Bela, z rjavkasto prevleko, ovalna tableta dolžine 20 mm s tremi paralelnimi zarezami.
For use 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 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 the product in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia.
Ne uporabljajte pri psih, ki so oboleli za hipoadenokorticizmom, hiperkaliemijo ali hiponatriemijo.
Do not administer spironolactone in conjunction with NSAIDs to dogs with renal insufficiency.
Ne uporabljajte skupaj z NSAID (nesteroidno protivnetno zdravilo) pri psih z insuficienco ledvic.
2/ 25 4.5 Special precautions for use
2/ 25 4. 5 Posebni previdnostni ukrepi
Special precautions for use in animals Kidney function and serum potassium levels should be evaluated before initiating combined treatment with spironolactone and ACE inhibitors.
Posebni previdnostni ukrepi za uporabo pri živalih Pred začetkom kombiniranega zdravljenja s spironolaktonom in ACE inhibitorji je treba oceniti ledvično funkcijo in nivo serumskega kalija.
Monitoring of their renal function and plasma potassium levels is recommended before initiation and during treatment with combined therapy (see 4.3).
(glej 4. 3).
As spironolactone has an antiandrogenic effect, 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 biotransformation, care should be taken when using the product to treat dogs with hepatic dysfunction.
Spironolakton lahko povzroči indukcijo in inhibicijo citokrom P450 encimov in lahko vpliva na metabolizem drugih zdravil, ki uporabljajo te metabolne poti.
Special precautions to be taken by the person administering the veterinary medicinal product to animals May cause skin sensitisation: persons known to be allergic to spironolactone should not handle the product.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Lahko povzroča kožne reakcije: osebe z znano preobčutljivostjo na spironolakton naj se izogibajo stiku z zdravilom.
In the event of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Do not use during pregnancy and lactation because developmental toxicity has been observed in laboratory species.
Ne uporabljajte pri brejih živalih in živalih v laktaciji, ker so pri laboratorijskih živalih opazili pojav razvojne toksičnosti.
In clinical studies, PRILACTONE was co-administered with furosemide and pimobendan without evidence of associated adverse reactions.
V kliničnih študijah je bil PRILACTONE apliciran v kombinaciji z furosemidi in pimobendanom brez očitnih škodljivih učinkov.
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).
Concomitant administration of spironolactone with ACE-inhibitors and other potassium-sparing drugs (as angiotensin receptor blockers, ß-blockers, calcium channels blockers, etc..) may potentially lead to hyperkalaemia (see 4.5).
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).
3/ 25 4.9 Amounts to be administered and administration route
3/ 25 4. 9 Odmerjanje in pot uporabe
2 mg of spironolactone per kg of body weight once daily.
2 mg spironolaktona na kg telesne mase enkrat dnevno.
The product should be administered with food.
Zdravilo se da primešano v hrano.
BODYWEIGHT 1 to 2.5 kg
TELESNA MASA
PRILACTONE PRILACTONE 10 mg Tablets 40 mg Tablets ½
PRILACTONE 10 PRILACTONE 40 PRILACTONE mg tableta mg tableta 80 mg tableta
PRILACTONE 80 mg Tablets
1 do 2. 5 kg
2.5 to 5 kg
2. 5 do 5 kg
2
½
3
3/ 4
After administration of up to 10 times the recommended dose (20 mg/ kg) to healthy dogs, dose- dependent adverse effects were noted, see section 4.6.
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.
It is therefore recommended to induce vomiting, lavage the stomach (depending on risk assessment) and monitor electrolytes.
Priporočljivo je izzvati bruhanje, izprati želodec (odvisno od ocene tveganja) in monitoring elektrolitov.
Symptomatic treatment, e. g., fluid therapy, should be provided.
Priporočljiva je simptomatska terapija kot so infuzije.
Aldosterone antagonist.
Antagonist aldosterona.
ATCvet code:
Oznaka ATC_ vet:
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.
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.
4/ 25 The renal effects of spironolactone and its metabolites lead to a decrease in extracellular volume and consequently in a decrease of cardiac preload and left atrial pressure.
4/ 25 Učinki spironolaktona in njegovih metabolitov v ledvicah vodijo do zmanjšanja ekstracelularnega volumna in posledično do zmanjšanega pritoka v srce in pritiska v levem atriju.
In a clinical trial, dogs treated with spironolactone in addition to standard therapy (ACE-inhibitors) demonstrated a reduction in cardiovascular disease deterioration compared to dogs treated with standard therapy alone.
Pri kliničnih testiranjih psov, tretiranih z spironolaktonom v kombinaciji s standardno terapijo (ACE - inhibitorji) je prišlo do zmanjšanja poslabšanj kardiovaskularnih bolezni v primerjavi s psi, ki so bili zdravljeni samo s standardno terapijo.
When used in combination with ACE-inhibitors, spironolactone may counteract the effects of “ aldosterone escape”.
Pri istočasni uporabi z inhibitorji ACE pride lahko do pojava, ki mu rečemo “ pobeg aldosterona ”
Absorption After oral administration of spironolactone to dogs, it was demonstrated that the three metabolites achieved levels of 32 to 49% of the administered dose.
Absorpcija Po peroralnem dajanju spironolaktona psom se je pokazalo, da trije metaboliti dosežejo nivoje 32 do 49% danega odmerka.
Food increases the bioavailability to 80 to 90%.
Hrana poviša biodostopnost do 80 do 90%.
Following oral administration of 2 to 4 mg/ kg, absorption increases linearly over the range.
Po peroralnem dajanju 2 to 4 mg/ kg, se absorpcija poviša linearno.