Country: Европска Унија
Језик: Енглески
Извор: EMA (European Medicines Agency)
osaterone acetate
Virbac S.A.
QG04CX90
osaterone acetate
Dogs
Urologicals
Treatment of benign prostatic hypertrophy (BPH) in male dogs.
Revision: 4
Authorised
2007-01-11
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 Прочитајте комплетан документ
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 Прочитајте комплетан документ