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Date: Saturday, May 21, 2022 7:09

Release 4.25
Prellim 0.075 mg/ml solution for injection for cattle and pigs
 
Species: Pigs, Cattle
Therapeutic indication: Pharmaceuticals: Hormones and therapeutically related products: Prostaglandins/others
Active ingredient: Cloprostenol Sodium
Product:Prellim® 0.075 mg/ml solution for injection for cattle and pigs
Product index: Prellim
Cattle - milk: Zero hours
Cattle - meat: 1 day
Pig - meat: 1 day
Presentation
Prellim is a solution for injection containing 0.075 mg/ml d-cloprostenol (as d-cloprostenol sodium). Also contains 1 mg/ml chlorocresol as preservative.
Uses
Indicated for the synchronisation or induction of oestrus and the induction of parturition in cattle. Also indicated for use in ovarian dysfunction (persistent corpus luteum, luteal cysts), interruption of pregnancy including foetal mummification, endometritis/pyometra and delayed uterine involution.
Indicated for the induction of parturition in pigs.
Dosage and administration
For intramuscular use.
Cattle: The recommended dose is 0.150 mg d-cloprostenol per animal, equivalent to 2 ml per animal.
Oestrus induction (also in cows with weak or silent heat): After determining the presence of corpus luteum (day 6-18 of the cycle), administer the product. Heat is generally observed in 48-60 hours. Inseminate 72-96 hours after this treatment. If heat is not observed, repeat after 11 days.
Parturition induction: Administer the product after day 270 of gestation. Parturition should occur 30-60 hours post-treatment.
Oestrus synchronisation: Administer the product twice (11 days apart). Inseminate artificially at 72 and 96 hours after the second injection.
Ovarian dysfunction: Once the presence of corpus luteum is determined, administer the product and inseminate in the first heat after the treatment. If no heat is observed, carry out a gynaecological examination again and repeat the injection 11 days after the first treatment. Inseminate at 72-96 hours post-treatment.
Endometritis or pyometra: Administer 1 dose of the product. Repeat the treatment 10-11 days later if necessary.
Gestation interruption: Administer the product during the first half of gestation.
Foetal mummification: Administer 1 dose of product. The foetus will be expelled after 3 or 4 days.
Retarded uterine involution: Administer 1 dose of the product and, if indicated, repeat the treatment once or twice at 24 hour interval.
Pigs: The recommended dose is 0.075 mg d-cloprostenol per animal, equivalent to 1 ml per animal.
Parturition induction: Administer the product after day 112 of gestation. Repeat after 6 hours. Alternatively, 20 hours after the initial dose of d-cloprostenol, a myometrial stimulant (oxytocin or carazolol) may be administered. Following the protocol of double administration, in about 70% of cases, parturition occurs 20-30 hours after the first treatment.
Contra-indications, warnings, etc
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals with spastic respiratory or gastrointestinal disease.
Do not use in gestating animals unless it is desirable to induce parturition or the interruption of pregnancy.
As with parenteral administration of any substance, basic aseptic rules should be observed. The injection site must be thoroughly cleaned and disinfected in order to reduce the risk of infection with anaerobic bacteria.
Occurrence of anaerobic infection is likely if anaerobic bacteria penetrate the tissue of the injection site. This applies especially to intramuscular injection and in particular to cows. Typical local reactions due to anaerobic infection are swelling and crepitus at the injection site.
Do not use in animals being treated with non-steroidal anti-inflammatory drugs, as the synthesis of endogenous prostaglandins is inhibited.
The activity of other oxytocic agents can be increased after the administration of cloprostenol.
Pigs: only use when the precise date of insemination is known. Administer on day 113 of gestation at the earliest. Administration of the product earlier may impair the viability and weight of the piglets.
Withdrawal period
Cattle: meat and offal: 1 day. Milk: zero hours.
Pigs: meat and offal: 1 day.
User warnings
d-Cloprostenol, like all F2α prostaglandins, can be absorbed through the skin and can produce bronchospasm and abortion.
Women of child-bearing age, asthmatics and persons with bronchial problems or any other type of respiratory problem must avoid any contact or use disposable plastic gloves when administering the product.
Do not eat, drink or smoke while handling the product.
The product must be handled carefully to avoid accidental self-injection or skin contact.
In case of accidental self-injection seek medical advice and show the label to the physician. Seek medical advice immediately in case of any respiratory difficulty caused by accidental inhalation or inoculation. In case of accidental skin contact, wash with soap and water immediately.
Pharmaceutical precautions
Protect from light. Avoid the introduction of contamination.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf-life after first opening the immediate packaging: 28 days.
Do not use after the expiry date which is stated on the label.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
Supplied in cardboard boxes with 1 vial of 2, 10 or 20 ml. Also supplied in cardboard box of 5 vials of 20 ml. Not all pack sizes may be marketed.
Further information
In safety studies, at 10 times the therapeutic dose, no adverse reactions were reported. As no specific antidote has been identified, in the case of overdose, symptomatic therapy is advised.
Marketing Authorisation Holder (if different from distributor)
Laboratorios SYVA, Spain
Marketing Authorisation Number
Vm 31592/4001
Significant changes
GTIN
GTIN description:1 x 20 ml:
GTIN:08436529621174
GTIN description:5 x 20 ml:
GTIN:08436529621167