natgillin/translations-raw huggingface dataset:
Resultaterne fra undersøgelserne viste, at hunde med kongestiv hjerteinsufficiens forårsaget af defekte hjerteklapper, som fik PRILACTONE tabletter som tillæg til anden hjertemedicin (‘ standardbehandling ’), havde en længere overlevelsestid end hunde, der fik standardbehandling plus placebotabletter.
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.
I en langtidsundersøgelse blev der hos hunde, der blev behandlet med PRILACTONE, endvidere set en mindre forværring af deres hjertesygdom sammenlignet med hunde, der kun fik ‘ standardbehandling ’.
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’.
Af de samme grunde bør PRILACTONE- tabletter ikke anvendes hos hunde i vækst.
For the same reasons, PRILACTONE tablets should not be used in growing dogs.
PRILACTONE- tabletter bør ikke gives til hunde med dårlig nyrefunktion, der får medicin, der er kendt som non- steroide anti- inflammatoriske midler (NSAID’ er).
PRILACTONE tablets should not be given to dogs with poor kidney function that are being given medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
PRILACTONE- tabletter bør ikke anvendes til hunde, der bruges til avl, eller som man påtænker at bruge til avl, da det er blevet påvist, at spironolacton kan medføre skade på nyfødte eller unge forsøgsdyr.
PRILACTONE tablets should not be used in dogs used for, or intended for use in breeding, as it has been demonstrated that spironolactone might cause harm to newborn or young laboratory animals.
Hvis det sker, at en person utilsigtet kommer til at sluge PRILACTONE- tabletter, skal der omgående søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
In case someone accidentally swallows PRILACTONE tablets, medical advice should be sought immediately and the Package Leaflet or the label should be shown to the physician.
Udvalget anbefalede udstedelse af markedsføringstilladelse for PRILACTONE.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of PRILACTONE outweigh its risks 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, and recommended that PRILACTONE be given a marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for PRILACTONE til CEVA SANTE ANIMALE den 20. juni 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for PRILACTONE to CEVA SANTE ANIMALE on 20 June 2007.
Foreslået Navn
Invented Name
Lægemid Dyreart Administrationsvej delform
Target Route of species administration
Tablet Hund Oral anvendelse
Oral use
Blister ((Polyamide/ Alu/ PVC) / Alu)
Blister ((Polyamide/ Alu/ PVC)/ Alu)
180 tabletter Ikke relevant
180 tablets N/ A
30 tabletter Ikke relevant
30 tablets N/ A
PRILACTONE 10 mg tabletter til hund PRILACTONE 40 mg tabletter til hund PRILACTONE 80 mg tabletter til hund
PRILACTONE 10 mg tablets for dogs PRILACTONE 40 mg tablets for dogs PRILACTONE 80 mg tablets for dogs
Aktivt indhold:
Active substance:
spironolacton 10 mg spironolacton 40 mg spironolacton 80 mg
10 mg 40 mg 80 mg
For udførlig liste over hjælpestoffer, se afsnit 6. 1.
For a full list of excipients, see
Todelt, oval tablet af 10 mm´s længde.
White, with a slight brownish mottling, bisected oval tablet of 10 mm length.
Oval tablet af 17 mm´s længde med tre parallelle brudlinjer.
White, with a slight brownish mottling, oval tablet of 17 mm length with three parallel break-lines.
Oval tablet af 20 mm´s længde med tre parallelle brudlinjer.
White, with a slight brownish mottling, oval tablet of 20 mm length with three parallel break-lines.
Til anvendelse i kombination med standard- behandling (omfattende vanddrivende behandling om nødvendigt) til behandling af kongestiv hjerteinsufficiens forårsaget af valvulært tilbageløb hos hunde.
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.
Bør ikke anvendes til dyr, der lider af hypoadrenokorticisme, hyperkalæmi eller hyponatriæmi.
Do not use the product in dogs suffering from hypoadrenocorticism, hyperkalaemia or hyponatraemia.
Bør ikke anvendes sammen med NSAID til hunde med renal insufficiens.
Do not administer spironolactone in conjunction with NSAIDs to dogs with renal insufficiency.
2/ 25 4. 5 Særlige forsigtighedsregler vedrørende brugen
2/ 25 4.5 Special precautions for use
Særlige forsigtighedsregler for dyret Nyrefunktion og serumkaliumniveau bør evalueres før indledning af kombineret behandling med spironolacton og ACE- inhibitorer.
Special precautions for use in animals Kidney function and serum potassium levels should be evaluated before initiating combined treatment with spironolactone and ACE inhibitors.
Hunde, der behandles med spironolacton og NSAID sideløbende, bør sikres korrekt væskeoptagelse.
Dogs treated concomitantly with spironolactone and NSAIDs should be correctly hydrated.
Monitorering af sådanne hundes renalfunktion og serumkalium anbefales før behandlingens start samt under behandlingsforløbet (se afsnit 4. 3).
Monitoring of their renal function and plasma potassium levels is recommended before initiation and during treatment with combined therapy (see 4.3).
Da spironolacton har en antiandrogen effekt, bør lægemidlet ikke anvendes til hunde i vækst.
As spironolactone has an antiandrogenic effect, it is not recommended to administer the product to growing dogs.
Da spironolacton gennemgår en ekstensiv hepatisk biotransformation, opmærksom ved anvendelse af produktet til hunde med leverdysfunktion.
As spironolactone undergoes extensive hepatic biotransformation, care should be taken when using the product to treat dogs with hepatic dysfunction.
Sensibilisering af hud kan forekomme: personer der er allergiske over for spironolactoner, bør ikke håndtere produktet.
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.
Søg læge i tilfælde at utilsigtet indtagelse og vis indlægsseddel og mærkning til lægen.
In the event of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Bør ikke anvendes til drægtige og lakterende dyr, da der hos laboratoriedyr er observeret udviklingsrelateret toksicitet.
Do not use during pregnancy and lactation because developmental toxicity has been observed in laboratory species.
PRILACTONE er i kliniske undersøgelser indgivet samtidigt med furosemid og pimobendan uden tegn på bivirkninger.
In clinical studies, PRILACTONE was co-administered with furosemide and pimobendan without evidence of associated adverse reactions.
Spironolacton nedsætter eliminationen af digoxin og hæver derved plasmakoncentrationen af digoxin.
Spironolactone decreases digoxin elimination and hence raises digoxin plasma concentration.
Da det terapeutiske indeks for digoxin er meget snævert, er det tilrådeligt at monitorere hunde, der både modtager digoxin og spironolactone, meget nøje.
As the therapeutic index for digoxin is very narrow, it is advisable to monitor closely dogs receiving both digoxin and spironolactone.
Administration af enten deoxycorticosteron eller NSAID sammen med spironolactone kan føre til en moderat reduktion af den spironolactons natriuretiske effekt (reduktion af natriumudskillelse i urinen).
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.
Samtidig administration af spironolacton og ACE- hæmmere eller andre kaliumbesparende lægemidler (som angiotensionreceptorblokkere, ß- blokkere, calciumkanalblokkere, etc.) kan potentielt føre til hyperkaliæmi. (se 4. 5).
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).
Spironolacton kan forårsage både induktion og inhibition af cytokrom P450 - enzymer og kan derfor afficere metabolismen af andre lægemidler, der metaboliseres på samme måde.
Spironolactone may cause both induction and inhibition of cytochrome P450 enzymes and could therefore affect the metabolism of other drugs utilizing these metabolic pathways.
4. 9 Dosering og indgivelsesmåde
3/ 25 4.9 Amounts to be administered and administration route
3/ 25 2 mg spironolacton pr. kg legemsvægt én gang dagligt.
2 mg of spironolactone per kg of body weight once daily.
Lægemidlet bør indgives sammen med foder.
The product should be administered with food.
LEGEMSVÆGT 1 til 2, 5 kg
BODYWEIGHT 1 to 2.5 kg
PRILACTON 10 mg tabletter ½
PRILACTONE PRILACTONE 10 mg Tablets 40 mg Tablets ½
PRILACTON 40 PRILACTON 80 mg tabletter mg tabletter
PRILACTONE 80 mg Tablets
2, 5 til 5 kg
2.5 to 5 kg
Se afsnit 4. 6.
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.
Det anbefales i så tilfælde at inducere vomitus samt at foretage lavage af ventriklen( afhængig af risikovurdering).
It is therefore recommended to induce vomiting, lavage the stomach (depending on risk assessment) and monitor electrolytes.
Symptomatisk behandling som f. eks. væsketerapi bør indledes.
Symptomatic treatment, e. g., fluid therapy, should be provided.
5 FARMAKOLOGISKE OG IMMUNOLOGISKE OPLYSNINGER
PHARMACOLOGICAL PROPERTIES
Aldosteron antagonist.
Aldosterone antagonist.
Spironolacton og dets aktive metabolitter (inklusiv 7α- thiomethyl- spironolacton og canrenon) fungerer som en specifik antagonist i forhold til aldosteron, og udøver deres effekt ved kompetitiv binding til mineralokortikoid- receptorer, lokaliseret i nyrer, hjerte og blodkar.
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.
Spironolacton er et natriuretisk lægemiddel (historisk beskrevet som et svagt diuretikum).
Spironolactone is a natriuretic drug (historically described as a soft diuretic).
I nyrerne inhiberer spironolacton den aldosteron- inducerede natriumretention, hvilket fører til en øget udskillelse af natrium og dermed følgelig vand, samt retention af kalium.
In the kidney, spironolactone inhibits the aldosterone-induced sodium retention leading to increase in sodium and subsequently water excretion, and potassium retention.
Den renale effekt af spironolacton og dets metabolitter fører til et fald i ekstracellulærvolumen og deraf følgende nedsættelse af preload og tryk i venstre forkammer.
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 I det cardio- vasculære system, forebygger spironolacton de nedbrydende effekter af aldosteron.
In the cardiovascular system, spironolactone prevents the detrimental effects of aldosterone.
Selvom den præcise virkningsmekanisme endnu ikke er veldefineret, fremmer aldosteron fibrose af myokardiet, myocardiel og vasculær remodellering og endothelial dysfunktion.
Although the precise mechanism of action is not yet clearly defined, aldosterone promotes myocardial fibrosis, myocardial and vascular remodelling and endothelial dysfunction.
I en klinisk undersøgelse udviste hunde, der blev behandlet med spironolacton sideløbende med standardbehandling (ACE - inhibitorer), en mindre grad af forværring af den kardiovaskulære sygdom end hunde, der udelukkende blev behandlet med standardbehandling.
In experimental models in dogs, it was shown that long term therapy with an aldosterone antagonist prevents progressive left ventricle dysfunction and attenuates left ventricle remodelling in dogs with chronic heart failure.
Spironolacton kan, ved anvendelse i kombination med ACE- hæmmere, modvirke effekten af “ aldosteron escape ”.
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.
I eksperimentelle modeller hos hunde er det vist, at langtidsbehandling med en aldosteron- antagonist forebygger progressiv dysfunktion af venstre ventrikel og mindsker remodelleringen af venstre ventrikel hos hunde med kronisk hjerteinsufficiens.
When used in combination with ACE-inhibitors, spironolactone may counteract the effects of “ aldosterone escape”.
Farmakokinetikken for spironolacton er baseret på dennes metabolitter, da spironolacton selv er meget ustabil ved prøvetagning.
The pharmacokinetics of spironolactone are based on its metabolites, as the parent compound is unstable at assay.
Optagelse Efter oral administration af spironolacton til hunde, er det vist, at de tre metabolitter når et niveau på 32 til 49% af den administrerede dosis.
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.
Foder øger biotilgængeligheden til 80- 90%.
Food increases the bioavailability to 80 to 90%.
Efter oral adminstrering af 2 til 4 mg/ kg øges absorptionen lineært indenfor måleområdet.
Following oral administration of 2 to 4 mg/ kg, absorption increases linearly over the range.
Der observeredes ingen akkumulering efter indgivelse af adskillige orale doser på 2 mg spironolacton pr. kg i 10 på hinanden følgende dage.
After multiple oral doses of 2 mg spironolactone per kg for 10 consecutive days, no accumulation is observed.
For de primære metabolitter, 7α- thiomethyl- spironolacton og canrenon opnås gennemsnitlige Cmax- værdier på 382 µg/ l og 94 µg/ l efter henholdsvis 2 og 4 timer.
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.
Steady- state forhold indtræder på dag 2.
Steady-state conditions are reached by day 2.
Fordeling Det gennemsnitlige distributionsvolumen for 7α- thiomethyl- spironolacton og canrenon er henholdsvis ca. 153 liter og 177 liter.
Distribution The mean volumes of distribution (Vss) of 7α -thiomethyl-spironolactone and canrenone are approximately 153 litres and 177 litres respectively.
Den gennemsnitlige opholdstid (MRT) for metabolitterne spænder fra 9- 14 timer, og de distribueres fortrinsvis til mavetarmkanal, nyrer, lever og binyrer.
The mean residence time of the metabolites ranges from 9 to 14 hours and they are preferentially distributed to the gastro-intestinal tract, kidney, liver and adrenal glands.
Metabolisering Spironolacton metaboliseres hurtigt og fuldstændigt i leveren til dets aktive metabolitter, 7α - thiomethyl- spironolacton og canrenon, der er de primære metabolitter hos hunden.
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.
Elimination Spironolacton udskilles hovedsageligt via dets metabolitter.
Elimination Spironolactone is mainly excreted via its metabolites.
Plasmaclearance for canrenon er 1, 45±0, 39 l/ time/ kg og for 7α- thiomethyl- spironolacton 0, 89±0, 44 l/ time/ kg.
Plasma clearance of canrenone is 1.45±0.39 l/ h/ kg and 7α -thiomethyl-spironolactone is 0.89±0.44 l/ h/ kg.
Efter oral administration af radioaktivt mærket spironolacton til hunde blev 70% af dosis genfundet i fæces og 20% i urinen.
After oral administration of radiolabelled spironolactone to the dog, 70% of the dose is recovered in faeces and 20% in the urine.
5/ 25 Natriumlaurylsulfat Mikrokrystallinsk cellulose Povidon Sorbitol Talcum Magnesiumstearat
PHARMACEUTICAL PARTICULARS
6. 2 Uforligeligheder Ingen relevante.
Not applicable.
6. 3 Opbevaringstid 3 år i salgspakning.
3 years as packaged for sale.
Rester af delte tabletter bør opbevares i den originale blisterpakning.
Partially used tablets should be stored in the original blister pack.
6. 5 Emballage Emballage:
Material of the primary container
Blisterpakning( polyamid/ aluminium/ polyvinylchlorid/ aluminium) i en papæske.
Blister packs (polyamide/ aluminium/ polyvinyl chloride/ /aluminium) in a cardboard box.
Æske indeholdende 3 blistre á 10 tabletter Æske indeholdende 18 blistre á 10 tabletter
Box containing 3 blisters of 10 tablets Box containing 18 blisters of 10 tablets
6. 6 Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
CEVA SANTE ANIMALE Z. I. la Ballastière 33500 LIBOURNE Frankrig
CEVA SANTE ANIMALE Z. I. la Ballastière 33500 Libourne France
EU/ 2/ 07/ 074/ 001 – 002 (10 mg tabletter) EU/ 2/ 07/ 074/ 003 – 004 (40 mg tabletter) EU/ 2/ 07/ 074/ 005 – 006 (80 mg tabletter)
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)
6/ 25 FORBUD MOD SALG, UDLEVERING OG/ ELLER BRUG
PROHIBITION OF SALE, SUPPLY AND/ OR USE
B
Not applicable.
Detaljeret information vedrørende dette produkt er tilgængelig på European Medicines Agency (EMEA) ´s hjemmeside http: // www. emea. europa. eu
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
7/ 25 ANNEX II
7/ 25 ANNEX II
BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN, HERUNDER BEGRÆNSNINGER FOR UDLEVERING OG BRUG
AUTHORISATION REGARDING SUPPLY OR USE
FORBUD MOD SALG, UDLEVERING OG/ ELLER BRUG
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
INDEHAVER AF FREMSTILLINGSTILLADELSE ANSVARLIG FOR BATCH RELEASE
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Navn og adresse på fremstiller ansvarlig for batch release.
Name and address of the manufacturer responsible for batch release
Très le Bois 22600 LOUDEAC Frankrig
Très le Bois F-22600 Loudeac France
SÆRLIGE FORHOLD ELLER RESTRIKTIONER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE LEVERING ELLER ANVENDELSE.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Indehaver af markedsføringstilladelsen skal informere den Europæiske Kommission markedsføringsplaner for veterinærlægemidlet, der er godkendt ved denne beslutning.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
SÆRLIGE FORHOLD ELLER RESTRIKTIONER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE SIKKERHED OG EFFEKTIVITET AF PRODUKTET.
CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
ANGIVELSE AF MRL - værdier.
STATEMENT OF THE MRLs
9/ 25 ANNEX III
9/ 25 ANNEX III
MÆRKNING OG INDLÆGSSEDDEL.
LABELLING AND PACKAGE LEAFLET
11/ 25 OPLYSNINGER TIL YDRE PAKNING
11/ 25 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10 mg tabletter
Carton box labelling – 10 mg tablets
PRILACTONE 10 mg tabletter til hund Spironolacton.
PRILACTONE 10 mg tablets for dogs Spironolactone.
Hver tablet indeholder 10 mg spironolacton
Each tablet contains 10 mg spironolactone
Tablet
Tablets
Oral anvendelse Læs indlægssedlen i pakningen før anvendelse
Read the package leaflet before use.
Læs indlægssedlen i pakningen før anvendelse.
Read the package leaflet before use.
UDLØBSDAT0
EXPIRY DATE
{Måned/ år}
{month/ year}
Rester af delvist brugte tabletter bør opbevares i den originale blisterpakning.
Store partially used tablets in the original blister pack.
SÆRLIGE FORHOLDSREGLER FOR BORTSKAFFELSE AF AFFALD ELLER RESTER AF LÆGEMIDLET
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Læs indlægssedlen.
Disposal: read package leaflet.
ORDENE “ KUN TIL DYR ” OG RESTRIKTIONER FOR ANVENDELSE
THE WORDS “ FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
ORDENE “ OPBEVARES UTILGÆNGELIGT FOR BØRN ”
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
EU/ 2/ 07/ 074/ 001 (3 blistre á 10 tabletter) EU/ 2/ 07/ 074/ 002 (18 blistre á 10 tabletter)
EU/ 2/ 07/ 074/ 001 (3 blisters of 10 tablets) EU/ 2/ 07/ 074/ 002 (18 blisters of 10 tablets)
13/ 25 OPLYSNINGER TIL YDRE PAKNING
13/ 25 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
40 mg tabletter
Carton box labelling – 40 mg tablets
PRILACTONE 40 mg tabletter til hund Spironolacton.
PRILACTONE 40 mg tablets for dogs Spironolactone.
Hver tablet indeholder 40 mg spironolacton
Each tablet contains 40 mg spironolactone.
DOSERING OG ADMINSTRATIONSMÅDE
METHOD AND ROUTE(S) OF ADMINISTRATION
Rester af delte tabletter bør opbevares i den originale blisterpakning.
Store partially used tablets in the original blister pack.
Se indlægssedlen
Disposal: read package leaflet.
EU/ 2/ 07/ 074/ 003 (3 blistre á 10 tabletter) EU/ 2/ 07/ 074/ 004 (18 blistre á 10 tabletter)
EU/ 2/ 07/ 074/ 003 (3 blisters of 10 tablets) EU/ 2/ 07/ 074/ 004 (18 blisters of 10 tablets)
FREMSTILLERENS BATCH NUMMER
MANUFACTURER’ S BATCH NUMBER
15/ 25 OPLYSNINGER TIL YDRE PAKNING
15/ 25 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
80 mg tabletter
Carton box labelling – 80 mg tablets
PRILACTONE 80 mg tabletter til hund Spironolacton.
PRILACTONE 80 mg tablets for dogs Spironolactone.
Hver tablet indeholder 80 mg spironolacton
Each tablet contains 80 mg spironolactone.
EU/ 2/ 07/ 074/ 005 (3 blistre á 10 tabletter) EU/ 2/ 07/ 074/ 006 (18 blistre á 10 tabletter)
EU/ 2/ 07/ 074/ 005 (3 blisters of 10 tablets) EU/ 2/ 07/ 074/ 006 18 blisters of 10 tablets
FREMSTILLERENS BACTHNUMMER
MANUFACTURER’ S BATCH NUMBER
17/ 25 MINIMUMS OPLYSNINGER TIL BLISTRE ELLER MÆRKATER
17/ 25 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Blisterfolie á 10 tabletter
Blister foil of 10 tablets
PRILACTONE 10 mg tabletter Spironolacton
PRILACTONE 10 mg tablets Spironolactone
Lot: {xxxxx}
Lot:
ORDENE “ KUN TIL DYR ”
THE WORDS “ FOR ANIMAL TREATMENT ONLY”
18/ 25 MINIMUM OPLYSNINGER TIL BLISTRE ELLER MÆRKATER
18/ 25 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
PRILACTONE 40 mg tabletter Spironolacton
PRILACTONE 40 mg tablets Spironolactone
19/ 25 MINIMUM OPLYSNINGER TIL BLISTRE ELLER MÆRKATER
19/ 25 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
PRILACTON 80 mg tabletter Spironolacton
PRILACTONE 80 mg tablets Spironolactone
21/ 25 INDLÆGSSEDDEL
21/ 25 PACKAGE LEAFLET
Indehaver af markedsføringstilladelse:
Marketing authorisation holder:
CEVA SANTE ANIMALE Z. I. la Ballastière 33500 LIBOURNE Frankrig Tel: + 33 (0) 5 57 55 40 40 Fax: + 33 (0) 5 57 55 40 06 e- mail: prilactone@ ceva. com
CEVA SANTE ANIMALE Z. I. la Ballastière 33500 Libourne France Tel: + 33 (0) 5 57 55 40 40 e-mail: contact@ceva. com
Fremstiller for batch release:
Manufacturer for batch release:
Très le Bois 22600 LOUDEAC Frankrig
Très le Bois 22600 Loudéac France
Spironolacton
Spironolactone
INDHOLD
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Hjælpestoffer inkluderer oksekødssmag.
Excipients include beef flavouring.
Til anvendelse i kombination med standard behandling (omfattende vanddrivende behandling om nødvendigt) til behandling af kongestiv hjerteinsufficiens forårsaget af valvulært tilbageløb hos hund.
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.