PMSG Intervet 5000IU, Powder and Solvent for Solution for Injection

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

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Hent Produktets egenskaber (SPC)
20-03-2024

Aktiv bestanddel:

Serum Gonadotrophin

Tilgængelig fra:

MSD Animal Health UK Limited

ATC-kode:

QG03GA03

INN (International Name):

Serum Gonadotrophin

Lægemiddelform:

Powder and solvent for solution for injection

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cattle, Dogs, Pigs, Sheep

Terapeutisk område:

Hormone sex

Autorisation status:

Authorized

Autorisation dato:

1994-08-03

Produktets egenskaber

                                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 
                                
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