Cyclix 250 microgram/ml Solution for Injection for Cattle

Composition

1 ml solution for injection contains:

Active substance(s):

Cloprostenol sodium 263 micrograms

(corresponding to 250 micrograms cloprostenol)

Excipient(s):

Benzyl alcohol (E1519) 20 mg

For a full list of excipients, see section 6.1.

6.1 List of excipients

Benzyl alcohol (E1519)

Citric Acid Monohydrate As a pH adjuster

Sodium Citrate

Sodium Chloride

Sodium Hydroxide As as pH adjuster

Water for injections

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Pharmaceutical form

Solution for Injection Colourless solution.

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Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Prostaglandins ATCvet code: QG02AD90 The Prostaglandin F2α analogue cloprostenol has luteolytic activity. Following its administration plasma progesterone falls to baseline levels. Progesterone concentrations start to decrease as early as 2 hours following injection. As a consequence, females with a sensitive CL (i.e. at least 5 days old) return to oestrus within 2-5 days of treatment and ovulate.

The effect of cloprostenol on the smooth muscular system is similar to that of Prostaglandin F2α itself.

5.2 Pharmacokinetic particulars

Following intramuscular injection, cloprostenol is rapidly adsorbed and peak cloprostenol concentrations are generally reached within the first 15 minutes after injection. Blood cloprostenol concentrations steadily decrease with a mean half life of approx. 56 min.

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Target species

Cows

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Indications

Induction of luteolysis allowing resumption of oestrus and ovulation in cyclic females when used during dioestrus, synchronisation of oestrus (within 2 to 5 days) in groups of cyclic females treated simultaneously, treatment of suboestrus and uterine disorders related to a functioning or persistent corpus luteum (endometritis, pyometra), treatment of ovarian luteal cysts, induction of abortion until day 150 of pregnancy, expulsion of mummified foetuses, induction of parturition.

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Dosage

For all indications, 2 ml corresponding to 0,5 mg cloprostenol/animal, injected intramuscularly.

In order to synchronise oestrus in groups of females, it is recommended that the product is administered on two occasions with a between treatment interval of 11 days.

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Contraindications

Do not use in pregnant animals, for which induction of abortion or parturition is not intended. Do not use in animals with spastic diseases of the respiratory or gastrointestinal tract.

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Adverse reactions

Anaerobic infection may occur if anaerobic bacteria penetrate the tissue at injection site, in particular following intramuscular injection.

When used for induction of parturition and dependent on the time of treatment relative to the date of conception, the incidence of retained placenta may be increased.

In very rare cases, anaphylactic-type reactions can be observed which might be life-threatening and require rapid medical care.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated, displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated )

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

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Warnings

Special precautions for use in animals

As with parenteral administration of any substance, basic aseptic rules should be observed. The injection site must be thoroughly cleaned and disinfected in order to reduce the risk of infection with anaerobic bacteria.

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

People with known hypersensitivity to benzyl alcohol should avoid contact with the product.

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

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. The product must be handled carefully to avoid ACCIDENTAL SELF-INJECTION OR SKIN CONTACT. Pregnant women, women in childbearing age, asthmatics and persons with other respiratory tract diseases should exercise caution when handling cloprostenol. Those persons should wear rubber (or plastic) gloves during administration of the product. Accidental spillage on the skin should be washed immediately with soap and water.

In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.

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Use during pregnancy, lactation or lay

Do not use in pregnant animals, for which abortion or induction of parturition is not intended. The product can be safely used during lactation.

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Interactions

Concurrent use of oxytocin and cloprostenol increases effects on the uterus. The activity of other oxytocic agents can be increased after the administration of cloprostenol.

Do not use in animals being treated with non-steroidal anti-inflammatories, as the synthesis of endogenous prostaglandins is inhibited.

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Overdose

Therapeutic tolerance in cattle is broad. Overdoses of more than 10 times are generally well tolerated. Large overdoses may cause transient diarrhoea. No antidotes are available.

An overdose will not accelerate corpus luteum regression.

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Special warnings

None

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Withdrawal period

Cattle:

Meat and offal: 2 days Milk: Zero days

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Incompatibilities

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

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Immediate packaging

20 ml and 50 ml colourless glass vials (glass type I, Ph.Eur.) closed with a halogenobutyl rubber stopper, with or without teflon coating.

An aluminium crimp cap with an integral plastic tamper-evident cover is fixed over the rubber stopper.

Secondary packaging: cardboard box.

Not all pack sizes may be marketed.

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Storage

Keep the vial in the outer carton Protect from light.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years. Shelf-life of the veterinary product after first opening the immediate packaging: 28 days.

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Disposal of unused product

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

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Additional information

Vm 05653/5038

9 DATE OF FIRST AUTHORISATION

9 February 2006

10 DATE OF REVISION OF THE TEXT

July 2023

Approved 13 July 2023

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Registration holder

VIRBAC

1ère avenue 2065m LID

06516 Carros

France

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