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Date: Monday, September 20, 2021 21:19

Description: MSD-AH
Telephone: 01908 685685 (Customer Support Centre)
Release 2.77
Incurin 1 mg tablets
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Hormones and therapeutically related products: Other sex hormones
Active ingredient: Estriol
Product:Incurin® 1 mg tablets
Product index: Incurin Tablets
Qualitative and quantitative composition
Active substance: estriol 1 mg/tablet.
See list of full excipients in section "Pharmaceutical particulars".
Pharmaceutical form
Round single-scored tablets.
Clinical particulars
Target species
Dogs (bitches).
Indications for use
The treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches.
Contra-indications
Do not use in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches. Animals showing a polyuria-polydipsia should not be treated with Incurin. The use of Incurin is contraindicated during pregnancy, lactation and in animals younger than 1 year.
Special warnings for each target species
High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors (mammary glands).
Special precautions for use
In case of oestrogenic effects, the dose should be lowered.
Adverse reactions
Oestrogenic effects 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 rare cases development of alopecia has also been observed.
Use during pregnancy or lactation
Do not use this product during pregnancy or lactation. See also Contraindications above.
Interactions
None known.
Amounts to be administered and administration route
For oral administration. A relationship between final effective dose and body weight has not been established and therefore the dose has to be determined for each dog on an individual basis. The following dosing schedule is advised: start treatment with 1 tablet (1 mg estriol) every day. If treatment is successful, lower the dose to half a tablet a day. If treatment is not successful, increase the dose to 2 tablets a day to be given in one dose. Some dogs do not need daily treatment; treatment every other day may be tried, once the effective daily dose has been established. The minimum dose given should not be less than 0.5 mg per dog per day. Ensure the dose used to achieve the therapeutic effect is as low as possible. Do not use more than 2 tablets per dog per day. If no response to treatment is obtained the diagnosis should be reconsidered in order to investigate other causes for the incontinence such as neurological disorders, bladder neoplasia, etc. Animals should be re-examined every 6 months during treatment.
Overdose
In case of overdose typical oestrogen effects may occur. These effects are reversible after lowering the dose.
Withdrawal periods
Not applicable.
Pharmacological particulars
Pharmacotherapeutic group: estrogens, ATCvet code: QG03CA04.
Pharmacodynamic properties
Estriol is a short-acting natural oestrogen. In ovarioectomised female dogs it has a beneficial effect on urinary incontinence. In the target animal safety study and the clinical trials, including long-term treatment, no signs of bone marrow suppression were observed. This is probably due to the short-acting oestrogenic character of estriol.
Pharmacokinetic properties
After oral administration Estriol is nearly completely absorbed from gastrointestinal tract. Nearly the whole Estriol is bound to Albumin in Plasma. Estriol is excreted in conjugated form via the urine. After oral administration of multiple doses no accumulation occurs.
Pharmaceutical particulars
Excipients
Amylopectin, Potato starch, Magnesium stearate and Lactose
Major incompatibilities
None.
Shelf life
3 years.
Special precautions for storage
Do not store above 30°C.
Immediate packaging
Blister package of clear PVC film backed by aluminium foil provided with heat seal coating (vinyl copolymer) on the side in contact with the tablets. One blister contains 30 tablets.
Pack size: carton box with 1 blister.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
UK(NI): Intervet International B.V., The Netherlands
Marketing Authorisation Number
UK(GB): Vm 01708/5038
UK(NI): EU/2/00/018/001
Significant changes
Date of the first authorisation or date of renewal
15 March 2000
Date of revision of the text
15 March 2010
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Incurin 1mg 1x30tab:
GTIN:8713184156327