Cycloprost 5 mg/ml Solution for Injection

Summary of Product characteristics

                                Revised: October 2012
AN: 00754/2012
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cycloprost 5mg/ml Solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of product contains:
ACTIVE SUBSTANCE(S):
MG
Dinoprost
5.00
EXCIPIENTS:
Phenol
2.50
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cycloprost is indicated for its luteolytic effect on corpora lutea in
cattle. This
luteolytic action of Cycloprost may be utilised as follows. 1. To
improve control
of the time of oestrus in cycling cattle. 2. To control breeding in
cattle. 3. To
induce parturition in cattle. 4. Synchronisation of recipient cattle
for embryo
transplantation. 5. To induce abortion in cattle. 6. To treat cattle
which have a
functional corpus luteum but do not express behavioural oestrus
(sub-oestrus or
silent heat). 7. For treatment of chronic metritis and pyometra in
cattle. 8. For
treatment of ovarian luteal cysts.
4.3
CONTRAINDICATIONS
Do not administer by the intravenous route.
Animals should not be treated if they suffer from either acute or sub
acute
disorders of the vascular system, gastrointestinal tract or
respiratory system.
Page 1 of 4
Revised: October 2012
AN: 00754/2012
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Cycloprost is ineffective when administered prior to day 5 after
ovulation.
Observe aseptic precautions during use.
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Prostaglandins of the F
2
a
type can be absorbed through the skin and may
cause bronchospasm or miscarriage.
Care should be taken when handling the product to AVOID SELF-
INJECTION OR SKIN CONTACT.
In case of accidental self-injection, seek medical advice immediately
and
show the packa
                                
                                Read the complete document