Luteprost 0.075 mg/ml solution for injection

Active ingredient(s)

Each ml contains:

Active substance:

D-cloprostenol (sodium)…………………………………….………….0.075 mg

Excipients:

Clorocresol ………………………………………………………………….. 1 mg

Other excipients, sufficient quantity.

Indications

Cattle (cows):

Indications for breeding: Synchronisation or induction of oestrus. Induction of parturition.

Therapeutic indications: Ovarian dysfunction (persistent corpus luteum, luteal cysts), induction of miscarriage in the first half of gestation. Expulsion of mummified foetus, endometritis/pyometra, delayed uterine involution.

Pigs (sows):

Indications for reproduction: Induction of parturition.

Horses (mares):

Indications for reproduction: Induction of oestrus. Induction of parturition. Induction of parturition.

Therapeutic indications: Interruption of prolonged diestrus (persistent corpus luteum) and physiologically prolonged anestrus (following lactation, abortion or early foetal death, in false pregnancy).

Contra-indications

Do not use in pregnant animals unless labour or abortion is desired.
Do not use in case of hypersensitivity to the active substance or any excipient.
Do not use in animals with cardiovascular, gastrointestinal or respiratory problems.
Do not use to induce labour in mature sows or cows with suspected dystocia due to mechanical obstruction or if problems due to abnormal foetal position are expected.

Special precautions

LUTEPROST is not recommended for use in mares with severe respiratory and/or gastrointestinal diseases.
As with the parenteral administration of any substance, basic antiseptic measures should be applied. The injection site should be adequately cleaned and disinfected to reduce the risk of infection by anaerobic bacteria.

In humans:
This veterinary medicinal product, like all F2α type prostaglandins, can be absorbed through the skin and may cause bronchospasm or miscarriage.
Care should be taken when handling the product to avoid self-injection or contact with the skin or mucosa of the person administering the medicine.
Pregnant women, women of child-bearing age, asthmatics and people with other respiratory problems should wear disposable water-resistant gloves when administering the veterinary medicinal product.
In case of accidental spillage onto the skin, wash immediately with soap and water.
In case of accidental self-injection, consult a doctor and show him/her the instructions for use. If breathing discomfort occurs following inhalation or accidental injection, use a fast-acting bronchodilator such as isoprenaline or salbutamol for inhalation.
Do not eat, drink or smoke while handling the medicinal product.

Posology

Cattle (cows) The recommended dose is 0.150 mg d-cloprostenol/animal, equivalent to 2 ml/animal.

• Oestrus induction (also in cows showing weak or silent oestrus): Administer the drug after determining the presence of the corpus luteum (6th-8th day of the cycle). Oestrus is generally observed within 48-60 hours. Inseminate 72-96 hours after the previous treatment. If no oestrus is observed, repeat after 11 days.
• Parturition induction: Administer the medicinal product after gestation day 270. Parturition should occur 30-60 hours post-treatment. Delivery should occur 30-60 hours after treatment.
• Oestrus synchronisation: Administer the drug twice (11 days apart). Artificially inseminate 72 and 96 hours after the second injection.
• Endometritis or pyometra: Administer 1 dose of the drug. If necessary, repeat the treatment 10-11 days later.
• Gestation interruption: Administer the veterinary medicinal product during the first half of gestation.
• Foetal mummification: Administer 1 dose of the drug. The foetus will be expelled after 3 to 4 days.
• Retarded uterine involution: Administer 1 dose of the veterinary medicinal product and, if indicated, repeat the treatment once or twice, 24 hours apart.

Horses (mares): The recommended dose is 0.075 mg d-cloprostenol/animal, equivalent to 1 ml/animal. Repeat if necessary as indicated.

• Induction of oestrus: After determining the presence of corpus luteum (from day 5 of the cycle), administer the medicinal product.
• Parturition induction: Administer the medicinal product after gestation day 320. Parturition generally takes place after a few hours. Delivery usually takes place after a few hours.
• Insemination schedule: Administer the drug twice (14 days apart). Inseminate on the 19th and 21st day after the first treatment, even in the absence of external signs of oestrus.
• Interruption of prolonged diestrus: Once the presence of corpus luteum has been observed, administer the medicinal product to induce oestrus. Oestrus will take place between 2 and 8 days after treatment, and ovulation between 8 and 10 days after treatment.
• Gestation interruption: Administer the veterinary medicinal product during the first half of gestation.
• Early foetal death: Administer the medicinal product after confirming the presence of corpus luteum.
• Anestrus during lactation: Administer the medicinal product 20-22 days after parturition, after checking the cycling activity. Heat and ovulation will then take place. Heat and ovulation will then take place.

Pigs (sows):The recommended dose is 0.075 mg d-cloprostenol/animal, equivalent to 1 ml/animal.

• Induction of labour: Administer the drug after day 112 of gestation. Can be repeated after 6 hours. Following the double administration protocol, in approximately 70 % of cases, delivery occurs 20-30 hours after the first treatment. Alternatively, 20 hours after the initial dose, a myometrial stimulant (oxytocin or carazolol) can be administered as long as labour has started.

Waiting time

Cattle (cows):Meat: 0 days.

Milk: 0 hours.

Pigs (sows):Meat: 1 day.

Horses (mares): Meat: 1 day.

Packaging

Box with one 2 ml vial

Box with 1 x 10 ml vials

Box with 1 x 20 ml vials

Box with 5 x 20 ml vials

Box with 12 vials of 2 ml.

Dispensing conditions:

Medicinal product subject to veterinary prescription

Administration conditions:

Administer under supervision of the veterinarian.

Reg. no. 2075 ESP