SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

CIDR 1.38g

(In AT, BE, BG, CY, CZ, EE, FI, FR, DE, EL, HU, IE, IT, LI, LT, LU, MT, NL, PL, PT, RO, SL, SK, ES, UK)

Relmont Vet

(In DK, IS, NO and SE)

Vaginal Delivery System for Cattle

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance(s):

Each device contains Progesterone. 1.38 g.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Vaginal delivery system.

A “T” shape device consists of progesterone impregnated silicone elastomer skin moulded over an inert nylon spine.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle (cows and heifers).

4.2 Indications for use, specifying the target species

For the control of the oestrous cycle in cycling cows and heifers, including:

• Synchronisation of oestrus in groups of animals including fixed time artificial insemination (FTAI) programmes.

• Synchronisation of donor and recipient animals for embryo transfer

To be used in combination with prostaglandin F2 or analogue.

Use as recommended normally results in oestrus 48-96 hours after device removal with the majority of animals showing oestrus within 48-72 hours.

For induction and synchronisation of oestrus in Fixed Time Artificial Insemination (FTAI) protocols:

• In cycling cows and heifers. To be used in combination with prostaglandin F2  (PGF2α) or analogue.

• In cycling and non-cycling cows and heifers. To be used in combination with Gonadotropin releasing hormone (GnRH) or analogue and PGF2α or analogue.

• In non-cycling cattle. To be used in combination with PGF2α or analogue and equine chorionic gonadotrophin (eCG).

4.3 Contraindications

Do not use:

• in cows or heifers, with abnormal or immature genital tracts, or with genital infections.

• in pregnant cattle.

• within the first 35 days after calving.

4.4 Special warnings for each target species

The progesterone treatment alone, according to dosage regimen proposed, is not sufficient to induce oestrus and ovulation in all cycling females. Progesterone based breeding protocols are reproduction management tools and should not replace adequate feeding and general health management. The choice of a specific protocol should be based on the requirements of the individual herd and it is advisable to examine cycling ovarian activity before using the progesterone treatment.

The response of cows and heifers to progesterone based synchronisation protocols is influenced by the physiological state at the time of treatment.

Responses to treatment can vary either across herds or across cows within herds.

However, the percentage of cows displaying oestrus within a given period is usually greater than in untreated cows and the subsequent luteal phase is of normal duration.

4.5 Special precautions for use

Animals in poor condition, whether from illness, inadequate nutrition, or other factors, may respond poorly to treatment.

Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product during insertion and removal. Insert the device using the applicator.

Wash hands and exposed skin with soap and water after use.

Do not eat, drink or smoke while handling the product.

4.6 Adverse reactions (frequency and seriousness)

Vaginal discharge associated with local irritation has been observed at removal of the insert. This discharge generally clears between the time of removal and insemination and has not been seen to affect conception rates following treatment.

4.7 Use during pregnancy, lactation or lay

Can be used during lactation.

The safety of the veterinary medicinal product has not been established, so do not use in pregnant cattle or within the first 35 days after calving. Laboratory studies in rat and rabbit, after intramuscular or subcutaneous administrations, and at repeated high doses of progesterone, have produced evidence of foetotoxic effects.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

1.38g of progesterone (1 device) per animal for 7- 9 days (depending on indication).

For synchronisation of oestrus and synchronisation of donor and recipient animals for embryo transfer:

One device should be inserted into the vagina of each cow or heifer to be treated. The vaginal insert should be left in position for 7 days with an injection of a luteolytic dose of prostaglandin F2or analogue administered 24 hours prior to removal. In animals that respond to treatment the onset of oestrus generally occurs within 1-3 days after removal of the insert. Cows should be inseminated within 12 hours of first observed oestrus.

For the induction and synchronisation of oestrus for Fixed Time Artificial Insemination (FTAI):

The following FTAI protocols have been commonly reported in the scientific literature and should be used:

In cycling cows and heifers:

• Insert one CIDR 1.38g into vagina for 7 days.

• Inject a luteolytic dose of PGF2α or analogue 24 hours prior to device removal.

• FTAI 56 hours after removal of the device.

In cycling and non-cycling cows and heifers:

• Insert one CIDR 1.38g into vagina for 7- 8 days.

• Inject a dose of GnRH or analogue at CIDR 1.38g insertion.

• Inject a luteolytic dose of PGF2α or analogue 24 hours prior to device removal.

• FTAI 56 hours after removal of the device, or

• Inject GnRH or analogue 36 hours after CIDR 1.38g removal and FTAI 16 to 20 hours later.

In non-cycling cows:

The following FTAI protocol should be used:

• Insert one CIDR 1.38g into vagina for 9 days.

• Inject a luteolytic dose of PGF2α or analogue 24 hours prior to device removal.

• Inject eCG at CIDR 1.38g removal.

• FTAI 56 hours after removal of the device, or inseminate within 12 hours following first observed oestrus behaviour.

Administration

A device applicator should be used for administration, following the procedure described below:

Removal

The device may be removed by gently pulling on the string. On occasions the string may not be visible from the outside of the animal, in such cases it may be located in the posterior vagina using a gloved finger. Withdrawal of the device should not require force. If any resistance is encountered a gloved hand should be used to ease removal.

If there is any difficulty in removal from the animal beyond that itemised above veterinary advice must be sought.

The device is intended for single use only.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Not applicable.

4.11 Withdrawal periods

Meat and offal: zero days.

Milk: zero hours.

During the treatment milk can be used for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:Genito Urinary System and Sex Hormones,

ATCvet code: QG03DA04

5.1 Pharmacodynamic properties

The vaginal delivery system delivers progesterone at a controlled rate across the vaginal mucosa into the blood stream. This suppresses the release of gonadotrophin releasing hormone and consequently luteinising hormone from the anterior pituitary inhibiting follicle maturation and so controlling the oestrous cycle. After removal of the device, circulating blood levels of progesterone fall precipitously within 6 hours, allowing follicle maturation, behavioural oestrus and ovulation.

5.2 Pharmacokinetic particulars

The pharmacokinetic profile of progesterone when administered as a single device was characterised by a maximum concentration (C_max) in plasma of approximately 4.33 ng/ml achieved at 1.19 hours post-dosing (T_max) and an Area Under the Curve (AUC_) of 19.47 ng/ml.hr. Peak concentrations were followed by a decline in systemic exposure with an apparent elimination half-life (t_1/2) of 0.298 hours. After removal of the device, circulating blood levels of progesterone fall precipitously within 6 hours.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Silicone elastomer

Nylon spine

Polyester Tail

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

6.4 Special precautions for storage

Do not store above 30° C.

6.5 Nature and composition of immediate packaging

The devices are packed in heat-sealed low-density polyethylene sachets in units of 10 per sachet. Sachets are re-sealable (zip-line).

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. Marketing Authorisation number

Vm: 42058/4012

9. Date of renewal of the authorisation

Date:24 October 2012.

10. Date of revision of the text

Date: January 2014