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Date: Thursday, March 28, 2024 19:23

Release 3.98
CIDR 1.38g Vaginal Delivery System for Cattle
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Hormones and therapeutically related products: Other sex hormones
Active ingredient: Progesterone
Product:CIDR® 1.38 g Vaginal Delivery System for Cattle
Product index: CIDR 1.38 g
Cattle - milk: Zero days
Cattle - meat: Zero days
Incorporating:
Presentation
CIDR is presented as a “T” shaped device consisting of a progesterone impregnated silicone elastomer moulded over an inert nylon spine. Each device contains 1.38 g progesterone.
Uses
For the control of the oestrous cycle in cycling cows and heifers, including:
- Synchronisation of oestrus in groups of animals.
- Synchronisation of donor and recipient animals for embryo transfer.
To be used in combination with prostaglandin F 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 F2a (PGF) or analogue.
- In cycling and non-cycling cows and heifers. To be used in combination with Gonadotrophin releasing hormone (GnRH) or analogue and PGF or analogue.
- In non-cycling cattle. To be used in combination with PGF or analogue and equine chorionic gonadotrophin (eCG).
Dosage and administration
Vaginal use. 1.38 g 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 F 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 1.38 g into vagina for 7 days.
- Inject a luteolytic dose of PGF 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 1.38 g into vagina for 7- 8 days.
- Inject a dose of GnRH or analogue at CIDR 1.38g insertion.
- Inject a luteolytic dose of PGF 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 1.38 g removal and FTAI 16 to 20 hours later.
In non-cycling cows
The following FTAI protocol should be used:
- Insert one CIDR 1.38 g into vagina for 9 days.
- Inject a luteolytic dose of PGF or analogue 24 hours prior to device removal.
- Inject eCG at CIDR 1.38 g 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:
1Ensure that the applicator is clean and dipped in a non-irritant antiseptic solution before use.
2Wearing sterile disposable plastic gloves, fold the arms of the device and load into the applicator. The arms of the device should protrude slightly from the end of the applicator. Care should be taken to avoid unnecessary or prolonged handling of the product to minimise transfer of the active substance to the operator's gloves.
3Apply a small quantity of obstetrical lubricant to the end of the loaded applicator.
4Lift the tail and clean the vulva and perineum.
5Gently insert the applicator into the vagina, first in a vertical direction and then horizontally until some resistance is encountered.
6Make sure the removal string is free, press the handle of the applicator and allow the barrel to move back towards the handle. This releases the arms of the device, which will then retain the device in the anterior vagina.
7With the device correctly positioned, withdraw the applicator, leaving the removal string hanging from the vulva.
8The applicator should be cleaned and disinfected before being used on another animal.
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.
Contra-indications, warnings, etc
Do not use in cows or heifers with abnormal or immature genital tracts, or with genital infections. Do not use in pregnant cattle. Do not use within the first 35 days after calving.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Animals in poor condition, whether from illness, inadequate nutrition or other factors may respond poorly to treatment.
Cattle (cows and heifers):
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Vaginal discharge1, vulva irritation / vaginal irritation
1 observed at removal of insert, this discharge generally clears between the time of removal and the insemination and has not been seen to affect conception rates following treatment.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
The safety of the veterinary medicinal product has not been established during pregnancy. 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 shown evidence of foetotoxic effects.
Can be used during lactation.
Ensure correct administration of the product, including the use of a non-irritant antiseptic and lubricant (see administration instructions).
Withdrawal periods:
Meat & offal – zero days.
Milk – zero days.
Operator warnings:
Progesterone is a potent steroid hormone and may cause adverse effects on the reproductive system in cases of high or prolonged exposure. As adverse effects on unborn children cannot be ruled out, pregnant women should avoid using this veterinary medicinal product.
The veterinary medicinal product may cause skin and eye irritation as well as allergic skin rashes.
Avoid accidental contact with the eyes. In case of accidental ocular exposure, flush the eyes thoroughly with water.
Persons administering the veterinary medicinal product should avoid contact with the silicone section; pregnant women should completely avoid handling the veterinary medicinal product.
The device should be inserted using the veterinary medicinal product specific applicator.
Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product during insertion and removal.
Wash hands and exposed skin with soap and water after use.
Do not eat, drink or smoke while handling the veterinary medicinal product.
Pharmaceutical precautions
Do not store above 30°C.
Medicines should not be disposed of via wastewater. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
CIDR is supplied in heat-sealed low density polyethylene sachets containing 10 devices.
Further information
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 for 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.
At operator's discretion, when synchronising cattle, trimming of the CIDR string may be of benefit in order to avoid removal by other animals.
For administration only by a veterinarian for the following indications:
For induction and synchronisation of oestrus in non-cycling cattle in Fixed Time Artificial Insemination (FTAI) protocols:
- To be used in combination with Gonadotropin releasing hormone (GnRH) or analogue and PGF or analogue.
- To be used in combination with PGF or analogue and equine chorionic gonadotrophin (eCG).
Marketing Authorisation Number
UK(GB): Vm 42058/5114
UK(NI): Vm 42058/3014
Significant changes
GTIN
GTIN description:1 x 10 devices:
GTIN:05013457079807