Solution for injection. Clear, colourless solution containing carbetocin 0.07mg/ml as active substance and excipient chlorobutanol hemihydrate 2.0mg/ml

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.

Cows: For all indications: 3.0 - 5.0ml/animal, corresponding to 0.21 - 0.35mg carbetocin/animal.

Sows: For uterine atony, MMA and milk ejection 1.5 - 3.0ml/animal, corresponding to 0.105 - 0.21mg carbetocin/animal.

For shortening of total parturition duration as a part of the synchronisation of parturition in: 1.0ml/animal, corresponding to 0.07mg carbetocin/animal.

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

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

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 Reprocine 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 Reprocine.

Do not administer to accelerate parturition if the 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 the uterus, uterine torsion, relative foetal oversize or deformities of the birth canal

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

Reprocine is indicated to induce milk ejection.

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

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

A threefold overdose (0.6mg 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 (1.0mg of carbetocin/animal).

Cattle, pigs: - meat and offal zero days

Cattle: - milk zero days

In case of 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 accidental exposure. In case of accidental self-injection uterine contractions could be induced in pregnant women.

Store at 2 - 8 °C. Keep container in the outer carton.

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

Any unused product or waste material should be disposed of in accordance with national requirements.

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

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

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.

Carbetocin is, due to its strongly developed peptidase-resistance, 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 0.6mg of carbetocin in sows, a bi-compartmental kinetic was observed. The elimination half-life is approximately 85-100 min. There are no essential differences between intramuscular and intravenous administration.