Planate 87.5 micrograms/ml Solution for Injection

Composition

Each ml contains:

Active substance:

Cloprostenol 87.5 micrograms

(equivalent to 92 micrograms cloprostenol sodium).

Excipients:

Qualitative composition of excipients Quantitative composition if that and other constituents information is essential for proper administration of the veterinary medicinal product

Benzyl alcohol 20 mg

Citric acid

Sodium citrate dihydrate

Sodium chloride

Water for injection

Clear colourless solution, practically free from particles.

3

Pharmacological properties

4.1 ATCvet code: QG02AD90

4.2 Pharmacodynamics

Cloprostenol sodium, a (racemic) analogue of prostaglandin F2α (PGF2α), is a very potent luteolytic agent. It causes functional and morphological regression of the corpus luteum (luteolysis) followed by return to oestrus and normal ovulation. Furthermore, this group of substances has a contractile effect on the smooth muscles (uterus, gastro-intestinal tract, respiratory tract, vascular system). The veterinary medicinal product does not demonstrate any androgenic, oestrogenic or anti progesterone activity and its effect on pregnancy is due to its luteolytic property.

Unlike other prostaglandin analogues, cloprostenol has no thromboxane A2 activity and does not cause platelet aggregation.

4.3 Pharmacokinetics

After intramuscular injection, cloprostenol is rapidly absorbed at peak concentrations of 1.07 ng/mL within 8 minutes. Subsequently, cloprostenol is rapidly eliminated for 1.5 hours followed by a slower elimination phase that results in concentrations below the detection limit between 4 and 6 hours after the administration.

3

Target species

Pigs (sows and gilts).

3

Indications

Induction of farrowing one or two days before the estimated date of parturition.

3

Dosage

To be administered by deep intramuscular route with a needle at least 4 cm long. Administer a single dose of 2 ml per animal (equivalent to 175 micrograms of cloprostenol).

The stopper may be safely punctured up to 10 times. When treating groups of animals in one run, use a draw-off needle that has been placed in the vial stopper to avoid excess broaching of the stopper. The draw-off needle should be removed after treatment.

3

Contraindications

Do not use in pregnant animals in which the induction of parturition is not intended. Do not administer to induce parturition in animals with suspected dystocia due to mechanical obstruction or abnormal position, presentation and/or posture of the foetus.

Do not use in cases of bronchospasm or gastrointestinal dysmotility.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

3

Adverse reactions

Pigs (sows and gilts):

1 May occur if anaerobic bacteria enter the injection site and may become generalized. Careful aseptic techniques should be employed to decrease the possibility of these infections.

2 May be observed within 15 minutes post-injection and usually disappears after one hour.

3 May be caused by induction of parturition with any exogenous compound.

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.

3

Warnings

Special precautions for safe use in the target species:

To reduce the risk of anaerobic infections arising from vasoconstriction at the injection site, injections into contaminated (wet or dirty) skin areas should be avoided. Thoroughly clean and disinfect injection sites prior to administration.

Injection into adipose tissue may lead to incomplete absorption of the veterinary medicinal product.

Premature induction of farrowing will reduce the piglet`s birth weight and increase the number of stillborn piglets and non-viable and immature born piglets. It is essential that the mean length of gestation is calculated on each farm from past records and not to anticipate the term of gestation by more than two days.

Do not administer intravenously.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Prostaglandins of the F2α type, such as cloprostenol, may be absorbed through the skin and may cause bronchospasm or miscarriage.

Care should be taken when handling the veterinary medicinal product to avoid self-injection or skin contact.

Pregnant women, women of child-bearing age, asthmatics and persons with other respiratory tract diseases should avoid contact when handling this veterinary medicinal product.

Personal protective equipment consisting of impervious gloves should be worn when handling the veterinary medicinal product.

Accidental spillage on the skin should be washed immediately with soap and water. In case of accidental self-injection or spillage onto the skin seek medical advice immediately, particularly as shortness of breath may occur, and show the package label or leaflet to the physician.

This veterinary medicinal product may cause hypersensitivity reactions. People with known hypersensitivity to benzyl alcohol should avoid contact with the veterinary medicinal product.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3

Use during pregnancy, lactation or lay

Pregnancy:

Do not administer to pregnant animals unless the objective is to terminate pregnancy.

Fertility:

There is no effect on the subsequent reproductive performance of sows treated with cloprostenol and of gilts or boars born from treated animals.

3

Interactions

The concomitant use of oxytocin and cloprostenol increases the effects on the uterus.

Do not administer with non-steroidal anti-inflammatory drugs (NSAIDs) since they inhibit endogenous prostaglandin synthesis.

In animals to which a progestogen is being administered, a decrease in the response of cloprostenol can be expected.

3

Overdose

In general, an overdose can lead to the following symptoms: increased heart and respiratory rate, bronchoconstriction, increased body temperature, increased amounts of faeces and urine, salivation, nausea and vomiting. In worse cases transient diarrhoea may occur.

No antidotes are available: treatment should be symptomatic, assuming Prostaglandin F2α acts on smooth muscle cells.

3

Special warnings

The response of sows and gilts to induction of parturition may be influenced by the physiological state and the time of treatment. The vast majority of the animals, 95%, will commence farrowing within 36 hours of treatment. The majority of animals can be expected to respond within the period of 24+/- 5 hours following the injection, except in those cases where spontaneous parturition is imminent.

3

Withdrawal period

Meat and offal: 1 day.

3

Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

3

Immediate packaging

Colourless glass vial (Type I, Ph. Eur.), sealed with an ethyltetrafluoroethylene (ETFE) coated bromobutyl rubber stopper and secured with aluminium collars and flip-off caps.

Carton box containing 1 vial containing 20 ml solution for injection. Carton box containing 1 vial containing 50 ml solution for injection.

Not all pack sizes may be marketed.

3

Storage

Keep the vial in the outer carton in order to protect from light.

Do not freeze.

3

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.

3

Disposal of unused product

Medicines should not be disposed of via wastewater.

The veterinary medicinal product should not enter water courses as cloprostenol may be dangerous for fish and other aquatic organisms.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

3

Additional information

Vm 06376/5063

8 DATE OF FIRST AUTHORISATION

03 January 1996

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

October 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 04 November 2025

3

Registration holder

Intervet International B.V.

3