PRILIUM 300


Name of the veterinary medicinal product

PRILIUM 300 mg, powder for oral solution for dogs

imidapril


Application

Treatment of mild to severe heart failure due to mitral regurgitation or dilated cardiomyopathy.


Active ingredient (s) and other ingredients

1 bottle with 1.03 g powder contains:

Active ingredient (s):

Imidapril hydrochloride ……… 300.0 mg

Excipients, the knowledge of which is necessary for the proper administration of the product:

Sodium benzoate (E 211) …….. 30.0 mg


1 ml of the ready-to-use solution contains:

Active ingredient (s):

Imidapril hydrochloride ……….. 10.0 mg

Excipients, the knowledge of which is necessary for the proper administration of the product:

Sodium benzoate (E 211) ………. 1.0 mg


Contraindications

Hypotension, acute renal insufficiency, congenital heart disease, known hypersensitivity to an ACE inhibitor, hemodynamically relevant stenoses (aortic, mitral, pulmonary stenosis), hypertrophic-obstructive cardiomyopathy.


Side effects

Diarrhea, hypotension and accompanying symptoms (fatigue, dizziness and loss of appetite) are observed in rare cases. Vomiting may occur in very rare cases. If side effects of this type are identified, treatment should be suspended until the patient is restored.


If you notice a side effect in your animal (s) that is not listed in the package insert, tell your veterinarian or pharmacist.

Dosage for each species, type and duration of use:


The recommended dose is 0.25 mg / kg body weight orally once a day, i.e.


Dogs with a body weight of more than 8 kg receive 0.025 ml / kg PRILIUM 300 mg (corresponds to 1 ml / 40 kg).


PRILIUM 300 mg can be administered to the dog on an empty stomach or at mealtimes. It can be put directly into the mouth or mixed with the feed.


Preparation of the ready-to-use solution: Remove the cap and stopper and fill the bottle with the powder up to the mark (30 ml) with tap water. Put on the safety lock and tighten it.

Removal: Unscrew the childproof safety cap and insert the enclosed syringe into the adapter. Determine and withdraw the required dose using the syringe graduated in kg body weight. After the drug has been administered, close the bottle with the childproof safety cap and rinse the syringe with water.


The bottle with the ready-to-use solution should be kept in the refrigerator.


Instructions for correct use

See type of application.


Waiting period

Not applicable.


Special storage instructions

Bottle with powder: Do not store above 25 ° C.

Bottle with ready-to-use solution: Store in a refrigerator (2 ° C – 8 ° C).


Shelf life after dissolution or reconstitution according to the instructions

 77 days.


After this period has expired, any residues of the ready-to-use solution remaining in the container must be discarded. Do not use the medicine after the expiry date which is stated on the container and the outer packaging.


Special warnings

Special precautions for use in animals:

In dogs with hypovolaemia / dehydration, the use of ACE inhibitors can lead to a hypotensive crisis. In such a case, the water and electrolyte balance must be balanced immediately. Treatment should be suspended until the patient stabilizes. The usual parameters for monitoring kidney function should be checked regularly at the start of treatment and afterwards.


Special precautions for the user

If the medicine is accidentally taken, a doctor must be consulted immediately and the package leaflet or label shown to him.

Wash hands thoroughly after administering the drug. In case of contact with the eyes, rinse them with plenty of water.

The bottle must be closed with the childproof screw cap before it is placed in the refrigerator.


Use during pregnancy, lactation or lay

In studies in rats and rabbits, no teratogenic, embryotoxic or maternotoxic effects were found after therapeutic doses of imidapril. The parameters for reproductive performance were also unaffected. As no data on tolerability are available, PRILIUM 300 mg should not be used in pregnant and lactating bitches or in breeding dogs.


Interaction with other medicinal products and other forms of interaction

In the clinical study, PRILIUM 300 mg was used in combination with furosemide and digoxin. There was no evidence of intolerance. Diuretics and low-salt diets increase the effects of ACE inhibitors by activating the renin-angiotensin-aldosterone system (RAAS). High-dose diuretics and low-salt diets should therefore be avoided during treatment with an ACE inhibitor in order not to provoke the occurrence of hypotension with the clinical symptoms apathy, ataxia or rare syncope and renal insufficiency. If potassium-sparing diuretics are administered at the same time, regular monitoring of the serum potassium level must be carried out, since there is a risk of hyperkalaemia.


Overdose (symptoms, emergency measures, and antidotes) if necessary

Healthy dogs show no signs of intolerance after repeated doses of imidapril up to 5 mg / kg / day. An overdose can manifest itself with symptoms of hypotension such as apathy and ataxia. Treatment should be symptomatic.



Special precautions for disposal of unused medicine or waste materials, if necessary

Unused veterinary medicinal products should preferably be returned to pollutant collection points. When it is disposed of with household waste, it must be ensured that there is no improper access to this waste. Veterinary medicinal products must not be disposed of via wastewater or the sewage system.

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