Ovuplant 2.1 mg Implantation Tablets for Horses (Mares)

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Deslorelin acetate

可用日期:

Dechra Ltd

ATC代码:

QH01CA93

INN（国际名称）:

Deslorelin acetate

剂量:

2.1 milligram(s)

药物剂型:

Implant

处方类型:

POM: Prescription Only Medicine as defined in relevant national legislation

治疗组:

Horses

治疗领域:

deslorelin

疗效迹象:

Hormone

授权状态:

Authorised

授权日期:

2009-06-19

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ovuplant 2.1 mg Implantation Tablets for Horses (Mares)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each implantation tablet supplies 2.1 mg Deslorelin (as Deslorelin
Acetate).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Implantation tablets.
Solid cylindrical implant for subcutaneous use. The implant is
approximately 2.3 mm in diameter and 3.6 mm in length
and is supplied in a preloaded plastic syringe with an attached
stainless steel needle.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses (non-pregnant mares).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In mares: zootechnical treatment for the induction of ovulation within
48 hours, during oestrus in normally cycling
mares (in sexual season), with an ovarian follicle greater than 30 mm
diameter.
4.3 CONTRAINDICATIONS
_Cf._ Section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Mares should be implanted with the veterinary medicinal product when a
developing ovarian follicle greater than 30
mm in diameter has been detected by rectal palpation and/or
ultrasonography. In larger breeds, it may be necessary to
wait until the dominant follicle has progressed to 35 mm in diameter
before administration of the veterinary medicinal
product.
Treated mares should be bred or inseminated within the next 48 hours.
The mare should be monitored to ensure that
ovulation has occurred and that further breedings are not required. If
ovulation does not occur within 48 hours of
implantation, continue breeding according to routine management
procedures.
It has been noted that follicles were significantly smaller before
ovulation for deslorelin treated mares compared with
placebo mares. However, treatment had no effect on the percentage of
mares pregnant at days 18 or 50.
For all trials that evaluated conception and pregnancy rate, there
were no differences between deslorelin-treated and
non-treated mares at the end of the study.
Efficacy has not been established for ma