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Date: Sunday, June 16, 2024 5:39

Release 2.77
Chorulon® 1500 IU Powder and Solvent for Solution for injection
 
Species: Cattle, Dogs, Horses and other equidae
Therapeutic indication: Pharmaceuticals: Hormones and therapeutically related products: Pituitary hormones
Active ingredient: Chorionic Gonadotrophin
Product:Chorulon® 1500 IU Powder and Solvent for Solution for injection
Product index: Chorulon®
Cattle - milk: Zero hours
Cattle - meat: Zero days
Withdrawal notes: Horses - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Each vial of active contains:
Active substance:
Chorionic gonadotrophin 1500 IU
Each vial of solvent contains 5 ml of a sterile buffered solvent for reconstitution.
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Powder and solvent for solution for injection.
White powder and clear colourless solution.
Reconstituted solution is colourless.
Clinical particulars
Target species
Cattle, horses and dogs
Indications for use
Chorulon can be used in the following fertility problems in domestic animals:
- cases of repeated failure of conception in cows and heifers
- induction of ovulation in mares and bitches
- cases of cystic ovaries in cows and heifers
- anoestrus in mares and bitches
- delayed ovulation, prolonged pro-oestrus in bitches
- deficiency in libido in male dogs
Contraindications
None.
Special warning for each target species
None.
Special precautions for use
None.
Operator warnings
Care should be taken to avoid accidental self-injection; if accidental self-injection occurs, seek medical advice immediately and show the doctor this label.
Wash hands after use.
Adverse reactions
In rare cases, as with all protein preparations, anaphylactoid incidents may occur shortly after injection. Adrenalin injection (1:1,000) given intravenously or intramuscularly when symptoms appear is the standard treatment. The administration of corticosteroids may also be indicated.
Use during pregnancy or lactation
Not applicable.
Interactions
None.
Amounts to be administered and administration route
Reconstitute with the solvent provided, ensuring the freeze-dried plug is fully dissolved. Administer by intramuscular or intravenous injection, observing the usual aseptic precautions.
Cow and heifer:
Repeated failure of conception: 1500 IU - i.m. or i.v. at AI or mating.
Cystic ovarian disease (anoestrus, prolonged oestrus, nymphomania): 3000 IU - i.v.
Enhancement of luteal function: 1500 IU i.m. 12 days after insemination or mating.
Mare:
Suboestrus (follicles > 2 cm in diameter): 1500 – 3000 IU - i.m. or i.v., repeat after 2 days if necessary.
Induction of ovulation: 1500 – 3000 IU - i.m. or i.v 24 hours before AI or mating.
Bitch:
Anoestrus: 500 IU - i.m. or i.v. at first day of oestrus after pre-treatment with PMSG 20 IU/kg s.c. daily for 10 days.
Delayed ovulation, prolonged pro-oestrus: 100 - 800 IU/day - i.m, repeating treatment until vaginal bleeding disappears. Mate on behavioural oestrus.
Male dog:
Deficiency in libido: 100 -500 IU - i.m. twice weekly for up to 6 weeks, but if this is not possible then 100 – 500 IU i.m. 6-12 hours before mating may give a temporary effect.
Further information
The product has been used in cases of cryptorchidism in the dog prior to castration (100-500 IU i.m. twice weekly for up to 6 weeks). Treatment may be effective in some cases provided that the inguinal canal is patent, and that therapy commences early.
The product has intrinsic LH-like activity. Injection of 1500 IU 12 days after heat in cattle enhances the active life of the corpus luteum by 2 to 3 days, resulting in increased progesterone and suppression of oestradiol production. These changes are consistent with those observed after GnRH use at day 11-13 of the cycle which are believed to be responsible for the increased pregnancy rates seen after such use. The mode of action is however different, since the product does not rely on first stimulating an endogenous LH peak. This use of the product has not been investigated in the field.
Overdose
No specific treatment or antidote recommended.
Withdrawal periods
Cattle: Meat – Zero days.
Milk – Zero hours.
Horses: Meat – Zero days.
Pharmacological particulars
ATCvet code: QG03GA01
Pharmacotherapeutic group
Sex hormones and modulators of the genital system.
Pharmacodynamic properties
Chorulon is a freeze-dried presentation of hCG together with solvent for reconstitution. hCG is a gonadotrophin. It is a large glycoprotein composed of two non-covalently associated alpha and beta subunits.
The extensive glycosylation of the CTP tail of the beta subunit of hCG results in its extended half-life which reaches 27h in pigs. hCG increases follicle maturation by stimulating androgen production by the cal cells and causes ovulation of the dominant follicle . Owing to its long half-life, it also stimulates formation and function of the corpus luteum.
In the male, hCG stimulates formation of testosterone, thus influencing the development and maintenance of primary and secondary male sexual characteristics.
Pharmacokinetic properties
Following i.m or i.v. injection, hCG is rapidly absorbed. Bioavailability following i.m. injection is high. Cmax is reached within 8hours in all target species. More specifically, peak hCG concentration (0.05 IU/ml) in plasma of cows is achieved 45 minutes after i.v. injection of a dose of 3000 IU. The elimination half-life of hCG is about 10 hours in cattle, and 27h in pigs.
Pharmaceutical particulars
Excipients
Mannitol
Sodium Phosphate Dihydrate
Sodium Dihydrogen Phosphate Dihydrate
Sodium Acid Phosphate Dihydrate
Sodium Hydroxide or Phosphoric acid (for pH adjustment)
Water for injection
Nitrogen
Major incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after dilution or reconstitution according to directions: 24 hours at 2 – 8 °C.
Special precautions for storage
Storage before reconstitution: Do not store above 25 °C.
Storage after reconstitution: Protect from light. Any product not used immediately after reconstitution should be stored refrigerated (2 °C – 8 °C). Reconstituted product remaining 24 hours after preparation should be discarded safely.
This product does not contain an antimicrobial preservative. Avoid the introduction of contamination during use.
Immediate packaging
Powder: Clear, Type I glass vials with halobutyl rubber bung secured with an aluminium collar containing 1500 IU Chorionic gonadotrophin.
Solvent: Clear, Type I glass vials with halobutyl rubber bung secured with an aluminium collar containing 5 ml buffered sterile solvent.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4301
Significant changes
Date of the first authorisation or date of renewal
18 May 1994.
Date of revision of the text
April 2021.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
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