Reprocine 0.07 mg/ml Solution for Injection for Cattle and Pigs

Composition

Each ml contains:

Active Substance:

Carbetocin 0.07 mg

Excipients:

Clear, colourless solution.

3

Pharmacological properties

4.1 ATCvet code: QH01BB03

4.2 Pharmacodynamics

Carbetocin is a synthetic analogue of the posterior pituitary lobe hormone oxytocin and has its physiological and pharmacological main effects at the smooth muscle (induction and increase of contractions) of reproductive organs.

Carbetocin has the same effect as natural oxytocin: at the oestrogen stimulated uterus it causes a change from weak, spontaneous and irregular to synchronised, regular, increased and directed contractions. Moreover, in the mammary gland it produces physiological contractions of the myoepithelial cells in the alveolae and small lactiferous ducts as well as a simultaneous relaxation of the teat sphincter.

The action of carbetocin is prolonged and it causes an intensification of the physiological effect.

4.3 Pharmacokinetics

Carbetocin is, due to its strongly developed peptidase-resistance, much more slowly degraded in vivo and distinguishes itself by a prolonged efficacy. Carbetocin is much more lipophilic than exogenously applied oxytocin and therefore, a better distribution and a longer effect on the receptors occur. Beside the stability against proteases, this may also contribute to the prolonged increase of uterine tone activity. After administration of 0.6 mg of carbetocin, in sows a bicompartimental kinetic was observed. The elimination half-life is approximately 85 - 100 min. There are no essential differences between intramuscular and intravenous administration.

3

Target species

Cattle, pigs

3

Indications

Cow:

- Uterine atony during the puerperal period,

- Placental retention as a consequence of uterine atony

- Initiation of milk ejection in stress-induced agalactia or in conditions requiring udder emptying

Sow:

- Uterine atony during the puerperal period

- Supportive therapy of mastitis-metritis-agalactia (MMA-) syndrome

- Initiation of milk ejection

- Shortening of total parturition duration in sows: either after delivery of the first piglet or as a component of synchronisation of parturition in sows, which have not farrowed 24 hours after administration of an appropriate PGF2α (e.g. cloprostenol) not before day 113 of pregnancy.

3

Dosage

Intramuscular or intravenous use.

For single injection.

Cows

For all indications:

3.0 – 5.0 ml/animal, corresponding to 0.21 – 0.35 mg carbetocin/animal

Sows

For uterine atony, MMA and milk ejection:

1.5 – 3.0 ml/animal, corresponding to 0.105 – 0.21 mg carbetocin/animal

For shortening of total parturition duration as a part of the synchronisation of parturition:

1.0 ml/animal, corresponding to 0.07 mg carbetocin/animal

The dosage requirements can be variable within the indicated limits based on the assessment of the veterinarian.

In case of treatment for milk ejection in the cow and sow or supportive therapy in MMA-syndrome in sow, a repeated administration is possible after 1 to 2 days.

Special information:

The responsiveness to carbetocin of the myometrium is likely to be close to zero from the 5th to the 11th day post partum. Therefore, the administration of the veterinary medicinal product during this period is likely to be inefficient and should be avoided.

If treatment with carbetocin should fail, then it is advisable to reconsider the aetiology of the condition, specifically if hypocalcaemia could be a complicating factor.

In case of severe septic metritis, appropriate concomitant therapy should be instigated when administering the veterinary medicinal product.

3

Contraindications

Do not administer to accelerate parturition if cervix is not opened or if there is a mechanical cause for the delayed parturition such as physical obstruction, positional and postural abnormalities, convulsive labour, threatened rupture of uterus, uterine torsion, relative foetal oversize or deformities of the birth canal.

3

Adverse reactions

Cattle, pigs:

None known.

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:

The interval between two injections should not be shorter than 24 hours.

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

In case of an accidental self-injection of the veterinary medicinal product in non-pregnant women the following effects may occur: facial flushing and warmth, lower abdominal pain. These effects usually disappear within a short span of time.

Pregnant women, women post partum and breast-feeding women should not use this product, in order to avoid an accidental exposure. In case of accidental self-injection uterine contractions could be induced in pregnant women.

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 use during the whole or part of the pregnancy.

Lactation:

The veterinary medicinal product is indicated to induce milk ejection.

3

Interactions

The administration of oxytocin after the administration of the veterinary medicinal product is unnecessary. Due to a possible intensification of the effect of oxytocin, undesirable uterine spasms may be induced.

3

Overdose

Injection of more than twice the recommended dose rate (more than 0.4 mg of carbetocin/animal) could increase the stillbirth rate in older sows if administered during prolonged parturition.

A threefold overdose (0.6 mg of carbetocin/animal) may induce profuse lactation in sows that may result in diarrhoea, reduced weight gain and increased mortality in their piglets. Carbetocin is considered as moderately irritant. At the injection sites of treated animals, focal lymphocytic infiltration was observed at higher doses (1.0 mg of carbetocin/animal).

3

Special warnings

None.

3

Withdrawal period

Cattle, pig: meat and offal: Zero days

Cattle milk: Zero days

3

Incompatibilities

None known.

3

Immediate packaging

Colourless glass injection vial containing 50 ml or 10 ml, respectively, solution for injection closed with a rubber stopper and sealed with an aluminium cap.

1 x 50 ml, 12 x 50 ml or 6 x 10 ml solution for injection, packaged in an outer cardboard box.

Not all pack sizes may be marketed.

3

Storage

Store in a refrigerator (2°C - 8 °C).

Keep the container in the outer carton.

When transported in a vehicle by a veterinarian, the veterinary medicinal product should be kept in a cooler box.

3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

Shelf life after first opening the immediate packaging:

10 ml vial: 2 weeks

50 ml vial: 3 weeks

3

Disposal of unused product

Medicines should not be disposed of via wastewater.

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

7 MARKETING AUTHORISATION NUMBER

Vm 08007/5014

8 DATE OF FIRST AUTHORISATION

21 October 2004

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

June 2026

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.

Approved 23 June 2026

3

Registration holder

Vetoquinol UK Limited

3