产品特点
1/5
Dokument1
Oct. 10
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2/5
Dokument1
Oct. 10
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Syncrostim 500 IU lyophilisate and solvent for solution for injection for cattle and sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lyophilisate vials contains:
ACTIVE SUBSTANCE:
Equine serum Gonadotrophin (eCG, formerly known as PMSG) ............... 500 IU
Solvent vial contains:
Benzyl alcohol....................................................................................... 16.5 mg /ml
Reconstituted solution for 1 dose of 2 ml contains:
ACTIVE SUBSTANCES
Equine serum Gonadotrophin (eCG, formerly known as PMSG)
500 IU
EXCIPIENTS
Benzyl alcohol
33.0 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for solution for injection
Lyophilisate: freeze-dried product in the form of powder agglomerated in cotton-like pellets.
Solvent: clear colourless solution.
Reconstituted solution: clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, Sheep.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In non cycling cattle (cows and heifers) and in ewes and ewe-lambs:
Induction and synchronization of oestrus and ovulation. To be used in combination with a progestagen.
4.3
CONTRAINDICATIONS
See section 4.7.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
3/5
Dokument1
Oct. 10
In case of anaphylactic shock, symptomatic
_ _
treatment (e.g. adrenaline or corticoste
阅读完整的文件