Incurin
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
29-06-2015
Karatteristiċi tal-prodott
(SPC)
29-06-2015
Rapport ta 'Valutazzjoni Pubblika
(PAR)
24-02-2021
Ingredjent attiv:
estriol
Disponibbli minn:
Intervet International BV
Kodiċi ATC:
QG03CA04
INN (Isem Internazzjonali):
Estriol
Grupp terapewtiku:
Dogs
Żona terapewtika:
Sex hormones and modulators of the genital system
Indikazzjonijiet terapewtiċi:
The treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches.
Sommarju tal-prodott:
Revision: 7
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2000-03-24
Fuljett ta 'informazzjoni
13
B. PACKAGE LEAFLET
14
PACKAGE LEAFLET
INCURIN 1 MG TABLET
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch
release:
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
INCURIN 1 mg tablet
Estriol
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Active substance: estriol
1 mg/tablet
Round single-scored tablets.
4.
INDICATION
Incurin is indicated for the treatment of hormone-dependent urinary
incontinence due to sphincter
mechanism incompetence in female dogs.
5.
CONTRAINDICATIONS
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.
6.
ADVERSE REACTIONS
Mild, oestrogenic effects such as swollen vulva, swollen teats and/or
attractiveness for males have
been observed at the high dose of 2 mg. These effects are reversible
after lowering the dose. Further, in
some dogs, symptoms of nausea were observed. Because of its
short-acting oestrogenic properties,
Incurin does not induce bone marrow suppression in the dog.
In rare cases vaginal bleeding occurred. In rare cases development of
alopecia has also been observed.
If you notice any serious effects or other effects not mentioned in
this leaflet, please inform your
veterinary surgeon.
15
7.
TARGET SPECIES
Dog.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Incurin is intended for once daily oral administration.
Since there exists no relation between the final effective dose and
the body weight, a fixed dose per kg
body weight is not feasible. The dose has to be fixed for each dog on
an individual basis. The
following dosing schedule is advised: start treatment with 1 tabl
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
INCURIN 1 mg tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: estriol
1 mg/tablet
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Round single-scored tablets
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs (bitches).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The treatment of hormone-dependent urinary incontinence due to
sphincter mechanism incompetence
in ovariohysterectomised bitches.
4.3
CONTRAINDICATIONS
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
High doses of oestrogen may have a tumour-promoting effect in target
organs with oestrogen receptors
(mammary glands).
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
In case of oestrogenic effects, the dose should be lowered.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
3
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.
_ _
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Do not use this product during pregnancy or lactation. See also 4.3
Contraindications.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.9
AMOUNT(S) TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For oral administration.
A relationship between final effect
Aqra d-dokument sħiħ
