Ypozane
Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Αγγλικά
Πηγή: EMA (European Medicines Agency)
Φύλλο οδηγιών χρήσης
(PIL)
31-08-2021
Αρχείο Π.Χ.Π.
(SPC)
31-08-2021
Δημόσιας Έκθεσης Αξιολόγησης
(PAR)
21-07-2013
Δραστική ουσία:
osaterone acetate
Διαθέσιμο από:
Virbac S.A.
Φαρμακολογική κατηγορία (ATC):
QG04CX90
INN (Διεθνής Όνομα):
osaterone acetate
Θεραπευτική ομάδα:
Dogs
Θεραπευτική περιοχή:
Urologicals
Θεραπευτικές ενδείξεις:
Treatment of benign prostatic hypertrophy (BPH) in male dogs.
Περίληψη προϊόντος:
Revision: 4
Καθεστώς αδειοδότησης:
Authorised
Ημερομηνία της άδειας:
2007-01-11
Φύλλο οδηγιών χρήσης
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET
YPOZANE
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
MARKETING AUTHORISATION HOLDER AND MANUFACTURER:
VIRBAC S.A. –
1ère avenue
2065 m – LID–
06516 Carros –
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
YPOZANE 1.875 mg tablets for dogs
YPOZANE 3.75 mg tablets for dogs
YPOZANE 7.5 mg tablets for dogs
YPOZANE 15 mg tablets for dogs
Osaterone acetate
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each tablet contains 1.875 mg, 3.75 mg, 7.5 mg or 15 mg osaterone
acetate
4.
INDICATION(S)
Treatment of benign prostatic hypertrophy in male dogs.
5.
CONTRAINDICATIONS
None.
6.
ADVERSE REACTIONS
The most commonly reported adverse reactions are mild and transient
modifications of appetite, either
increased (very common) or decreased (very rare). Behavioural changes
such as modification of dog’s
activity or more social behaviour are common. Other adverse reactions
such as transient vomiting
and/or diarrhoea, increased thirst or lethargy occur less commonly.
The enlargement of mammary
glands occurs less commonly and can be associated with lactaction in
very rare cases.
Transient side-effects of changes in the hair coat such as hair loss
or hair modification have been seen
very rarely following administration of Ypozane.
All these adverse reactions are reversible without any specific
treatment.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated
)
- uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
25
- rare (more than 1 but less than 10 animals in 10,000 animals
treated)
- very rare (less than 1 animal in 10,000 animals treated, including
isolated reports).
If you notice any side effects, even those not already listed in this
package leaflet or you think that the
medici
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Αρχείο Π.Χ.Π.
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
YPOZANE 1.875 mg tablets for dogs
YPOZANE 3.75 mg tablets for dogs
YPOZANE 7.5 mg tablets for dogs
YPOZANE 15 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each tablet contains 1.875 mg, 3.75 mg, 7.5 mg or 15 mg osaterone
acetate
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Round, white, biconvex tablet of 5.5 mm, 7 mm, 9 mm and 12 mm.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs (male)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of benign prostatic hypertrophy (BPH) in male dogs.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS
In dogs with BPH associated with prostatitis, the product can be
administered concurrently with
antimicrobials.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
A transient reduction of plasma cortisol concentration may occur; this
may continue for several weeks
after administration. Appropriate monitoring should be implemented in
dogs under stress (e.g. post-
operative) or those with hypoadrenocorticism. The response to an ACTH
stimulation test may also be
suppressed for several weeks after administration of osaterone.
Use with caution in dogs with a history of liver disease, as safety of
use of the product in these dogs
has not been thoroughly investigated, and
_ _
as treatment of some dogs with liver disease has resulted in
reversible elevation of ALT and ALP in clinical trials.
3
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
Wash hands after administration.
In the case of accidental ingestion by a person, seek medical advice
immediately and show the
package leaflet or the label to the physician.
A single oral dose of 40 mg osaterone acetate in human males was
followed by a sporadic decrease in
FSH, LH and testosterone, reversible after 16 days. There was no
clinical effect.
In female laboratory animals, osaterone
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