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Ypozane tablets

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Tablets for the treatment of benign prostatic hyperplasia in the dog.

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27,78 € tax incl.

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31,57 € tax incl.

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Composition:
1,875 mg - 3.75 mg - 7.5 mg or 15 mg of osaterone acetate.

Indications:
Treatment of benign prostatic hypertrophy in dogs.

Contraindications:
Any.

Special precautions for use in animals:
A transient reduction in plasma cortisol concentration may occur for a few weeks after the administration of the product. In dogs under stress (eg: postoperative) or with hypoadrenocorticism, adequate monitoring should be implemented.
The response to the ACTH stimulation test may also be suppressed for a few weeks after the administration of osaterone.
Use with caution in dogs with a history of liver disease since the safety of the product in these cases has not been fully investigated and clinical trials in dogs with liver disease and treated with the product have shown a reversible increase in ALT and ALP.

Special precautions to be taken by the person administering the medicine:
Wash hands after use. In case of accidental ingestion, consult a doctor immediately and show him the text of the package or the package leaflet. A single dose of 40 mg of osaterone acetate in man causes a sporadic decrease in FSH, LH and testosterone, reversible after 16 days. There are no clinical effects. Laboratory studies in females have shown that osaterone acetate causes serious adverse effects on reproductive functions. Therefore, women of childbearing age should avoid contact with the veterinary drug or wear gloves when handling it.

Adverse reactions:
Very frequent: transient increase in appetite. Frequent: transient changes in behavior (increase or decrease in activity, or more sociable behavior) Rare: transient vomiting and / or diarrhea, polyuria / polydipsia, lethargy or feminization syndrome including hyperplasia of the mammary gland. The transient reduction of plasma cortisol appears in most treated animals. In clinical trials, treatment with the veterinary drug was not interrupted and all dogs recovered without specific therapy.

Use during pregnancy or lactation:
Does not apply

Interactions:
None known.

Posology and method of administration:
For oral administration.
Administer 0.25 - 0.5 mg of osaterone acetate per kg of live weight, once a day for 7 days as indicated in the following table:

WeightYpozane® tablet sizeNumber of tablets to be given dailyTreatment duration
3 -7.5 kg1.875 mg tablet1 TABLET7 DAYS
7.5 to 15 kg3.75 mg tablet1 TABLET7 DAYS
15 to 30 kg7.5 mg tablet1 TABLET7 DAYS
30 to 60 kg15 mg tablet1 TABLET7 DAYS

 
There are no data available for dogs weighing less than 3 kg liveweight.

The tablets can be administered directly in the animal's mouth or with food. The maximum dose should not be exceeded. The start of the clinical response to treatment usually occurs at 2 weeks. The clinical response persists for at least 5 months after treatment.
Re-evaluation of the veterinarian should be done 5 months after treatment or sooner if clinical signs are repeated. The decision to try again at that time or later must be based on the examination and assessment of the veterinarian taking into account the benefit-risk of the product. If the clinical response to treatment is considerably less than expected, a re-evaluation of the diagnosis will be necessary.

Overdosage:
The overdose study (with a dose of more than 1.25 mg / kg live weight for 10 days, repeated one month later) showed no adverse effects except the decrease in plasma cortisol concentration.

PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: A drug used in the benign hypertrophy of the prostate
ATCvet code: QG04C X
The osaterone is an antiandrogen steroid, which inhibits the effects of an excess production of male hormone (testosterone).

Pharmacodynamic properties:
Acetate acetate is a steroid chemically related to progesterone and as such has a potent progestogen and anti-androgen activity. The major metabolite of osaterone acetate (osaterone 15β-hydroxylate acetate) also has antiandrogenic activity. The acetate of osaterone inhibits the effects of an excess of male hormone (testosterone) through several mechanisms. Its competitiveness prevents the binding of androgens to their prostate receptors and blocks the transport of testosterone in the prostate.
No adverse effect on semen quality has been observed.

Pharmacokinetic data:
After oral administration with food in dogs, osaterone acetate is rapidly absorbed (Tmax of 2 h) and undergoes a first-pass effect mainly in the liver. After administering a dose of 0.25 mg / kg / day, the mean maximum concentration (Cmax) in plasma is 60 μg / l.
The acetate of osaterone becomes its main metabolite 15β-hydroxylate, which is also pharmacologically active. The acetate of osaterone and its metabolite bind to plasma proteins (90% and 80% respectively), mainly to albumin. This binding is reversible and does not affect other known substances specifically bound to albumin.
The osaterone is eliminated in 14 days, mainly in the faeces by biliary excretion (60%) and in a lower degree (25%) in the urine. Elimination is slow with a half-life (T ½) of 80 hours. After repeating the administration of osaterone acetate at 0.25 mg / kg / day for 7 days, the accumulation factor is 3-4 without changes in absorption or elimination rates. 15 days after the last administration, the mean plasma concentration is 6.5 ug / l.

Period of validity:
3 years.

Conservation:
It does not require any special storage conditions.
Any unused veterinary medicinal product or waste derived from it should be disposed of in accordance with local regulations.

Presentations and registration number:
YPOZANE 1,875 mg, box with 7 tablets EU / 2/06/068/001
YPOZANE 3.75 mg, box with 7 tablets EU / 2/06/068/002
YPOZANE 7.5 mg, box with 7 tablets EU / 2/06/068/003
YPOZANE 15 mg, box with 7 tablets EU / 2/06/068/004

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Ypozane tablets

Ypozane tablets

Tablets for the treatment of benign prostatic hyperplasia in the dog.

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