Incurin
European Medicines Agency Veterinary Medicines
EMEA/V/C/047
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
INCURIN
EPAR summary for the public
This document is a summary of the European Public Assessment Report. Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use. This document cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR)._
What is Incurin?
Incurin is a tablet containing the natural hormone estriol as active substance.
What is Incurin used for?
Incurin is used for the treatment of hormone-dependent urinary incontinence resulting from sphincter mechanism incompetence (SMI) in ovariohysterectomised bitches (i.e. in dogs having had the ovaries and uterus removed surgically).
As the sensitivity of incontinent dogs to estriol is variable, the dose has to be determined on an individual basis. For advise on dosing please see the Package Leaflet.
How does Incurin work?
Estriol contained in Incurin is a short-acting natural oestrogen which binds to the oestrogen receptor.
The term urinary incontinence is used to describe the condition of involuntary leakage of urine. It is known to occur in bitches, with the incidence being highest after ovariectomy. This condition is accompanied with a decrease of the endogenous oestrogen production. Scientific findings strongly suggest a relationship between the incidence of urinary incontinence and oestrogen depletion. Oestrogen receptors can be found in the urethral sphincter, where oestrogens induce a full response, this way improving urethral closure and bladder storage.
How has Incurin been studied?
Incurin has been studied in bitches in three large field trials. During the studies repeated administration of up to 2mg estriol per dog produced beneficial effects in bitches showing involuntary leakage of urine.
The studies also established that there is no apparent relationship between the dosage and the body weight of the dog - therefore the dosing has to be decided on an individual basis.
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What benefit has Incurin shown during the studies?
The majority of bitches involved in the studies responded positively: they became continent, and remained that way in the long term. The results show that Incurin is efficient and safe to use against urinary incontinence due to SMI in ovariohysterectomised dogs.
What is the risk associated with Incurin?
Incurin is not to be used in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches. Animals showing a polyuria-polydipsia (excessive water intake and consequent excretion of a large volume of urine) should also not be treated with this product.
Effects typical to oestrogens such as swollen vulva, swollen mammary glands and/or attractiveness to males and vomiting have been observed at the highest recommended dose of 2 mg per dog. The incidence is about 5-9 %. These effects are reversible after lowering the dose.
In rare cases vaginal bleeding occurred. In very rare cases development of alopecia (loss of hair) has also been observed.
What are the precautions for the person who gives the medicine or comes into contact with the animal?
No special precautions are necessary when administering Incurin.
Why has Incurin been approved?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Incurin excede the risks for the treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches, and recommended that Incurin be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.
Other information about Incurin:
The European Commission granted a marketing authorisation valid throughout the European Union for Incurin to Intervet International B.V. on 24 March 2000 and renewed in it 2005. Information on the prescription status of this product may be found on the label/outer package.
This summary was last updated in April 2008.
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©EMEA 2008