NOAH Compendium

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Date: Wednesday, September 19, 2018 19:00

MSD-AH
Release 3.4
Regumate Porcine 0.4 % w/v oral solution
 
Species: Pigs
Therapeutic indication: Pharmaceuticals: Hormones and therapeutically related products: Other sex hormones
Active ingredient: Altrenogest
Product:Regumate® Porcine 0.4 % w/v oral solution
Product index: Regumate Porcine
Pig - meat: 9 days
Qualitative and quantitative composition
Active ingredients
% w/v
Altrenogest
Other ingredients
0.4
Butylated hydroxytoluene (E321)
0.007
Butylated hydroxyanisole (E320)
0.007
Each 5 ml dose provides 20 mg Altrenogest.
For full list of excipients, see Pharmaceuticals Particulars.
Pharmaceutical form
Oral solution. Clear, pale yellow, odourless solution.
Clinical particulars
Target species
Pigs
Indications for use
For the synchronisation of oestrus and improvement of litter size in sexually mature gilts. For the synchronisation of oestrus and improvement of farrowing rate and litter size in sows.
Contra-indications
Do not administer to male animals. Do not administer to pregnant sows or those suffering from uterine infection. Part-consumed feed must be disposed of with other waste feed and not given to other animals.
Special warnings for each target species
None.
Special precautions for use
Not applicable.
Operator warnings:
Women who are pregnant, or suspected to be pregnant, should not use the product. Women of childbearing age should handle the product with extreme care. The product should not be handled by persons with known or suspected progesterone-dependent tumours or thrombo-embolic disorders.
Direct contact with the skin should be avoided. Personal protective clothing (gloves and overalls) must be worn when handling the product. Porous gloves may let this product pass through. Transcutaneous absorption may be even higher when the area is covered by an occlusive material, such as latex or rubber gloves. Accidental spillage on the skin should be washed off immediately with soap and water. Wash hands after treatment and before meals.
In case of accidental contact with eye, rinse abundantly with water. Get medical attention.
Effects of overexposure: Repeated accidental absorption could lead to disruption of the menstrual cycle, uterine or abdominal cramping, increased or decreased uterine bleeding, prolongation or pregnancy or headache.
Other precautions regarding impact on the environment
When spreading manure from treated animals, the minimum distance to surface water as defined in the national or local regulations has to be strictly respected, because the manure may contain altrenogest which could cause adverse effects in the aquatic environment.
Adverse reactions
Ensure the correct dose is administered daily as under-dosing can lead to the formation of cystic follicles.
Use during pregnancy, lactation or lay
Do not administer to pregnant sows.
Interactions
No interactions known.
Amounts to be administered and administration route
Gilts: One dose of 5 ml per gilt per day for 18 consecutive days given orally with feed for immediate consumption.
Sows: One dose of 5 ml per sow per day for 3 consecutive days given orally with feed for immediate consumption.
Administration of product supplied in pressurised 360 ml canister: Do not shake before use to avoid mixing the solution with the nitrogen included in this pressurised container. Animals should be segregated and dosed individually. Add the product as a top dressing to the feed using the metered dose applicator. Add to the surface of the feed immediately before feeding. Discard any remaining medicated feed.
Group feeding on the floor: Feed should be presented in such a manner that each pig is allowed sufficient floor space to get equal access to the feed. Once the animals have started feeding, dispense one dose of Regumate as a top-dressing on the feed in front of each pig.
Administration of product supplied in 540 ml and 1 L container (not pressurised):
- Remove the cap and the obturator.
- Measure the clinical dose of 5 ml using the dosing cup provided.
- Pour the dose on the feed.
- Close the bottle with the obturator and the screwable cap after each use.
Overdose
No special precautions required. Doses of 20 times the recommended dose did not affect pigs nor their offspring.
Withdrawal periods
Animals must not be slaughtered for human consumption during treatment. Pigs may be slaughtered for human consumption only after 9 days from the last treatment.
Pharmacological particulars
ATC Vet Code: QG03DX90
Pharmatherapeutic group: Sex hormones and modulators of the genital system, Progestogens, Other progestogens.
Pharmacodynamic properties
Altrenogest has a similar action to the natural hormone progesterone. When administered orally it suppresses the normal sexual cycle, preventing signs of heat and ovulation. Withdrawal of Regumate then allows the natural hormones to be released again and animals return to heat in a synchronised fashion.
Pharmacokinetic properties
Altrenogest is rapidly absorbed following oral administration, with peak plasma concentrations being reached between 1 and 4 hours after treatment. The liver is the main organ involved in altrenogest's metabolism and biliary excretion is its main route of elimination. Following treatment, circulating altrenogest concentrations decline biphasically. Half life of elimination was estimated to be around 14 hours.
Pharmaceutical particulars
Excipients
Butylated hydroxytoluene (E321), Butylated hydroxyanisole (E320) and Soya oil.
Major incompatibilities
None known.
Shelf life
Shelf life of the 360 ml container as packaged for sale: 2 years.
Shelf life of the 540 ml and 1 L bottle as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging of 540 ml and 1 L bottle: 90 days.
Special precautions for storage
Do not store above 25°C. Pressurised container; protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn even after use.
540 ml and 1 L bottle: does not require any special storage conditions.
Immediate packaging
360 ml pressurised container with a metering valve.
540 ml and 1 L aluminium bottle provided with an external translucent plastic dosing cup. The closure system comprises an obturator prolonged by a plastic ring inserted in the bottle neck and a screwable cap.
Not all pack sizes may be marketed.
Disposal
Regumate Porcine, 0.4% w/v oral solution should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 01708/4443
Significant changes
Date of the first authorisation or date of renewal
12 November 2005.
Date of revision of the text
December 2016.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Regumate Porcine 1x540ml:
GTIN:08713184149787,
GTIN description:Regumate Porcine 1x1L:
GTIN:08713184112965