Introduction

vet06701

Company name: Janssen Animal Health

A division of Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

Telephone: 01494 567555

Fax: 01494 567556

Email: ahealth@jacgb.jnj.com

Presentation

A sterile, aqueous solution for injection. Each ml contains 0.1 mg gonadorelin (synthetic gonadotrophin releasing hormone) as active ingredient and 10 mg benzyl alcohol as preservative.

Uses

The product is for administration to breeding cattle. Gonadorelin is the synthetic equivalent of natural gonadotrophin releasing hormone (GnRH) and administration results in the release of both LH and FSH from the pituitary, which will induce follicle maturation and subsequent ovulation following the normal physiological pattern.

In breeding cattle it may be used for:

-for the treatment of cystic ovaries

-prior to treatment with a prostaglandin for the induction of oestrus in dairy cows

-in association with AI to optimise the time of ovulation, improving the conception rate

-in the early post-partum period to initiate normal ovarian activity

Dosage and administration

Treatment of cystic ovaries:	0.5 mg (5 ml)
Other indications:	0.25 mg (2.5 ml)

Administer by deep intramuscular injection observing the normal aseptic precautions. Sterile equipment should be used for administration, but avoid contamination of product with traces of disinfectant or spirit.

Cystic ovaries

The presence of ovarian cysts may result in irregular return to oestrus or nymphomania. Anoestrus may be observed. The condition is diagnosed by rectal palpation revealing the presence of persisting follicular structures with a diameter over 2.5 cm and should be confirmed by the use of plasma or milk progesterone assay. A single dose of 5 ml Fertagyl should be given. Breeding cattle may be inseminated on the oestrus following treatment (20-22 days post injection). If short, irregular oestrus intervals persist, a second treatment may be administered. If oestrus is not observed by 14 days from the initial Fertagyl treatment, prostaglandin should be administered.

Use with prostaglandin for oestrus induction in dairy cows

A single injection of 2.5 ml Fertagyl should be given 7 days prior to administration of prostaglandin. A further injection of 2.5 ml Fertagyl should be given prior to service as indicated under “Use in conjunction with AI” below.

Use in conjunction with AI

The success of AI is dependent on the proper timing of insemination relative to the time of ovulation. A single injection of 2.5 ml Fertagyl on the day of AI has been shown to increase the conception rate in repeat breeder cattle (ie animals on the third or subsequent service) and in animals with a body condition score < 3, and on farms with lower than average conception rates.

Where a GnRH/prostaglandin regime is used to induce ovulation for fixed time service, cows should be given 2.5 ml Fertagyl 54-56 hours after the prostaglandin treatment and served 72 hours after prostaglandin (16-18 hours after Fertagyl). If cows are observed in oestrus before 56 hours, necessitating service before 72 hours, they should be served at oestrus and Fertagyl administered at or before the service.

Use in the post-partum cow

Many cows have resumed ovarian cyclicity by 30 days post-partum. A significant number do however remain acyclic and these would benefit from an early intervention using GnRH to initiate a resumption of ovarian activity. Cows with a history of slow resumption of cyclicity in one lactation tend to be slow again in subsequent lactations and may be identified from individual cow/herd records. An injection of 2.5 ml Fertagyl in the early post-partum period (<40 days) helps maintain an optimal calving to first service interval and may result in an improved conception rate to first service.

Contra-indications, warnings, etc

Not to be given to animals known to be hypersensitive to the active ingredient. Avoid accidental self-injection of this product. Wash hands after use. Not indicated for use during pregnancy.

Withdrawal Period

Meat and Milk: Zero (0) days.

Pharmaceutical precautions

Do not store above 25°C. Store out of light. Avoid the introduction of contamination during use. Should any apparent growth or discolouration occur, the product should be discarded. After withdrawal of the first dose, use within 28 days. Keep out of reach of children. For animal treatment only.

Disposal

Unused product and empty containers should be disposed of in accordance with any guidance from your local waste regulation authority.

Legal category

POM-V

Packaging Quantities

Packs of 10x5 ml vials.

Further information

The use of Fertagyl 7 days prior to prostaglandin increases the proportion of cows able to respond to the prostaglandin and co-ordinates a new follicular wave so more cows will ovulate during a shorter time after prostaglandin. A second Fertagyl treatment after the prostaglandin further tightens synchrony of ovulation in relation to the service time. Initial trial work indicates that this system is not suitable for heifers.

The GnRH/prostaglandin/ GnRH regime for breeding dairy cows at a pre-planned time without the need for specific heat detection is summarised below:

Day 0	Fertagyl 2.5 ml
Day 7 (am)	Prostaglandin
Day 9 (pm)	Fertagyl 2.5 ml	54-56 hours post prostaglandin or at AI if sooner
Day 10 (am)	AI	72 hours post prostaglandin or at observed heat if sooner.