Hypophysin LA 35 µg/ml Solution for Injection for Cattle and Pigs

Composition

Each ml contains:

Active substance:

Carbetocin 35 µg

Excipients:

Clear, colourless solution.

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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 600 µg 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.

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Target species

Cattle (cows), pigs (sows).

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Indications

Cattle (cows):

- 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

Pigs (sows):

- Acceleration or restart of parturition after disruption of uterine contractions (uterine atony or inertia) following the expulsion of at least one piglet

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

- Initiation of milk ejection

- Shortening of total parturition duration as a component of synchronisation of parturition in sows The product may be applied to sows which have previously been administered an appropriate PGF2α or PGF2α analogue (e.g. cloprostenol) not prior to day 114 of pregnancy and have not started farrowing within 24 hours after the PGF2α or PGF2α analogue injection (day 1 of pregnancy is the last day of insemination)

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Dosage

Intramuscular use. Intravenous use.

Cattle (cows):

For all indications:

6.0 – 10.0 ml/animal, corresponding to 210 – 350 µg carbetocin/animal

Pigs (sows):

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

1.0 ml/animal, corresponding to 35 µg carbetocin/animal

For acceleration or restart of parturition after disruption of uterine contractions (uterine atony or inertia) following the expulsion of at least one piglet:

1.0 - 2.0 ml/animal, corresponding to 35 - 70 µg carbetocin/animal

For MMA and milk ejection:

3.0 – 6.0 ml/animal, corresponding to 105 – 210 µg 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. The interval between two injections should not be shorter than 24 hours.

For all other indications stated in section 3.2 “Indications for use for each target species” the veterinary medicinal product should be administered once.

The rubber stopper of the vial may be safely punctured up to 25 times. Otherwise, automatic syringe equipment, or a suitable draw-off needle, should be used for the 50 ml and 100 ml vials to avoid excessive puncturing of the closure.

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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.

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

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Adverse reactions

Cattle (cows), pigs (sows):

1 In late pregnancy

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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

None.

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

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

Pregnant women, women post-partum and breast-feeding women should not administer this veterinary medicinal product, in order to avoid an accidental exposure. 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.

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

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

Carbetocin may be absorbed through the skin. In case of accidental contact with the skin, the corresponding area should be thoroughly cleaned with soap and water. In case of contact with the eyes, they should be thoroughly rinsed with water. People with known hypersensitivity to carbetocin or any of the excipients should avoid contact with the veterinary medicinal product.

Women of childbearing age should administer the veterinary medicinal product with special caution.

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.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

The veterinary medicinal product is indicated to induce milk ejection.

See also section 3.3 “Contraindications”.

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Interactions

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

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Overdose

An overdosing of more than 400 µg of carbetocin/animal could increase the stillbirth rate in older sows if administered during prolonged parturition.

An overdosing of 600 µg 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 (1000 µg of carbetocin/animal).

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Special warnings

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.

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Withdrawal period

Cattle, pigs:

Meat and offal: Zero days

Cattle:

Milk: Zero hours

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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

Vial of colourless glass, type I, with a fluorinated bromobutyl rubber stopper and an aluminium cap.

Pack sizes:

1 vial (10 ml) in a cardboard box.

1 vial (20 ml) in a cardboard box.

1 vial (50 ml) in a cardboard box.

1 vial (100 ml) in a cardboard box.

Not all pack sizes may be marketed.

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Storage

Store in a refrigerator (2 °C – 8 °C).

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

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after first opening the immediate packaging: 28 days.

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Disposal of unused product

Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater or household waste.

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.

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Additional information

Vm 27569/4003

8 DATE OF FIRST AUTHORISATION

05 August 2014

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

May 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: 28 May 2026

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Registration holder

Veyx-Pharma GmbH

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