Target species
Cattle, pigs
Indications for use for each target species
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.
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.
Special warnings
None.
Special precautions for use
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.
The veterinary medicinal product should not be administered by pregnant women, women post partum and breast-feeding women to avoid 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.
Adverse events
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.
Use during pregnancy, lactation or lay
Lactation:
The veterinary medicinal product is indicated to induce milk ejection.
Interaction with other medicinal products and other forms of interaction
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.
Administration routes and 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 MMAsyndrome 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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
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).
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.
Withdrawal periods
Cattle, pigs:
Meat and offal: Zero days
Cattle:
Milk: Zero days