Land: Storbritannien
Sprog: engelsk
Kilde: VMD (Veterinary Medicines Directorate)
Serum Gonadotrophin
MSD Animal Health UK Limited
QG03GA03
Serum Gonadotrophin
Powder and solvent for solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Dogs, Pigs, Sheep
Hormone sex
Authorized
1994-08-03
Revised: April 2021 AN: 00009/2021 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT PMSG Intervet 5000IU, Powder and Solvent for Solution for Injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of freeze-dried powder contains: _Active substance:_ Serum gonadotrophin 5000 iu (equivalent to 200iu/ml once diluted) For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. Vial containing white sterile freeze-dried powder plug and a vial containing sterile aqueous solution for reconstitution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, pigs, sheep and dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES PMSG is capable of supplementing and being substituted for both luteinising hormone and follicle stimulating gonadotrophin of the anterior pituitary gland in both the male and female, stimulating development of the ovarian follicle. 4.3 CONTRA-INDICATIONS Where the possibility of multiple ovulations, due to exaggerated response from prolonged blood concentrations, has not been excluded by clinical examination following administration of PMSG to uniparous species (unless to induce superovulation in cattle), it is inadvisable to permit service or insemination during the first heat produced. 4.4 SPECIAL WARNING FOR EACH TARGET SPECIES None Revised: April 2021 AN: 00009/2021 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals No special treatment or antidote recommended. Repeated administration can result in reduced efficacy due to the immune-mediated antagonism. ii. Special precautions to be taken by the person administering the medicinal product to the animals Care should be taken to avoid accidental self-injection. Wash your hands after use. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In rare cases, as with all protein preparations, anaphylactoid incidents may occur shortly after injection. Adrenaline injection (1:1000) given intravenously or intramuscularly Læs hele dokumentet