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Date: Saturday, May 18, 2024 18:15

Description: MSD-AH
Release 2.48
Planate® 0.0875 mg/ml solution for injection
 
Species: Pigs
Therapeutic indication: Pharmaceuticals: Hormones and therapeutically related products: Prostaglandins/others, Others
Active ingredient: Cloprostenol Sodium
Product:Planate® 0.0875 mg/ml solution for injection
Product index: Planate®
Pig - meat: 2 days
Incorporating:
Qualitative and quantitative composition
Each ml contains:
Active substance mg
Cloprostenol 0.0875
as Cloprostenol Sodium 0.092)
Excipients
Benzyl alcohol 20 mg
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Solution for injection
A colourless, buffered sterile, aqueous solution.
Clinical particulars
Target Species
Pigs (sows and gilts)
Indications for use
Parturition in sows and gilts, to facilitate the management of farrowing.
Contraindications
None
Special warnings for each target species
Special precautions for use
Induction of farrowing too early in pregnancy can lead to non-viable piglets being born. An increase in the number of non-viable piglets may result if used more than two days prior to the average gestation length calculated from farm records
Operator warnings
Direct contact with skin or mucous membranes of the user should be avoided. Prostaglandins of the F2α type may be absorbed through the skin and may cause bronchospasm or miscarriage. Care should be taken when handling the product to AVOID SELF-INJECTION OR SKIN CONTACT.
Pregnant women, women of child-bearing age, asthmatics and persons with other respiratory tract diseases should exercise caution when handling cloprostenol. Those persons should avoid contact or wear disposable plastic gloves during administration of the product.
Accidental spillage on the skin should be washed off immediately with soap and water.
The possible incidence of bronchospasm with the product is unknown. Should shortness of breath result from accidental inhalation or injection, seek urgent medical advice and show the doctor this warning. Wash hands after use.
Adverse Reactions
None known
Use during pregnancy or lactation
Do not use in pregnant animals when parturition is not intended.
Interactions
None known
Amounts to be administered and administration route
A single 2ml dose is given by deep intramuscular injection. It is recommended that a 1½ inch needle be used.
Having calculated the average gestation length for each farm, sows and gilts may be injected two days before this date or on any date thereafter to suit the requirements of the particular management system. Trials have shown that normally 95% of animals will commence farrowing within 36 hours of treatment. The majority of animals can be expected to respond within the period 24±5 hours following injection, except in those cases where spontaneous farrowing is imminent.
The product can be used under a variety of management systems to facilitate batch management of sows and gilts. This may help to minimise farrowing at antisocial times and planning husbandry around the farrowing period.
Overdose
No adverse reactions reported
Withdrawal periods
Animals must not be slaughtered for human consumption during treatment.
Pigs may be slaughtered for human consumption only after 2 days from the last treatment.
Pharmacological particulars
ATC Vet Code: QG02AD90
Pharmacotherapeutic group
Prostaglandins
Pharmacodynamic properties
Cloprostenol, a synthetic prostaglandin analogue, structurally related to Prostaglandin F2α (PGF2α), is a potent luteolytic agent which provokes a morphological and functional regression (luteolysis) of the corpus luteum in pigs.
Pharmacokinetic particulars
After its administration by injection, cloprostenol is metabolised to acid 9α, 11α, dihydroxy-15-ceto prost-5-enoic and 9α, 11α, 15-trihydroxyprost-5-enoic which rapidly disappears from the blood, being excreted via the urine in 5-6 hours.
Radiolabel studies show blood levels between 0.0014 and 0.002 μg per ml at 20 minutes - 2 hours after its administration. Subsequently, blood levels fall rapidly, having an apparent half life of 1-3 hours, falling below 0.00004 μg/ml at 8 hours. No significant concentrations are found at 24 hours in the liver, muscle, heart, kidneys, uterus, ovaries, skin, brain and fat.
Pharmaceutical particulars
Excipients
ChlorocresolBenzyl alcohol
Sodium citrate
Citric acid anhydrous
Sodium chloride
Water for injections
Major incompatibilities
None known
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale:
2 years
Shelf life after first opening the immediate packaging:
28 days
Special precautions for storage
Keep the vial in the outer carton in order to protect from light.
After 1st opening:
Do not store above 30 ºC.
Keep the vial in the outer carton in order to protect from light
Immediate packaging
20 ml colourless glass Type I vial, with bromobutyl ETFE coated stopper rubber bung with aluminium overseal.
Disposal
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4579
Significant changes
Date of the first authorisation or date of renewal
03/01/1996.
Date of revision of the text
November 2016.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
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