PG 600, Powder and Solvent for Solution for Injection

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Chorionic Gonadotrophin, Serum Gonadotrophin

Saatavilla:

MSD Animal Health UK Limited

ATC-koodi:

QG03GA99

INN (Kansainvälinen yleisnimi):

Chorionic Gonadotrophin, Serum Gonadotrophin

Lääkemuoto:

Powder and solvent for solution for injection

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Pigs

Terapeuttinen alue:

Hormone sex

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

1994-07-27

Valmisteyhteenveto

Revised: December 2020
AN: 01394/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PG 600, Powder and solvent for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each reconstituted 5ml dose contains:
Chorionic gonadotrophin
200 iu
Serum gonadotrophin
400 iu
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
White powder and clear colourless solution. Reconstituted solution is
colourless.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the promotion of a fertile oestrous cycle in gilts and in sows
post-weaning,
and the
treatment of suboestrus or anoestrus in barren sows due to hormonal
imbalance.
4.3
CONTRA-INDICATIONS
Do not inject into the subcutaneous fat.
4.4
SPECIAL WARNING FOR EACH TARGET SPECIES
None.
Revised: December 2020
AN: 01394/2020
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals.
When administered by the subcutaneous route, care must be taken to
avoid injection into subcutaneous fat. In the unlikely event of an
individual anaphylactic reaction, 1-3 ml
Adrenaline 1:1000 solution should be given by intramuscular injection.
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; if accidental
self-
injection occurs, seek medical advice and show the doctor this label.
Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None.
4.7
USE DURING PREGNANCY OR LACTATION
Not indicated for use during pregnancy. The injection of PG 600 into a
pregnant
sow or gilt will fail to produce heat and will not cause abortion.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Reconstitution: Reconstitute by injecting approximately 2 ml of the
solvent
provided into the hormone vial, ensure