Lutalyse 12.5 mg/ml Solution for Injection for Cattle

Summary of Product characteristics

                                Revised: April 2021
AN: 01269/2020
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Lutalyse 12.5 mg/ml solution for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Dinoprost
12.5 mg (as Dinoprost tromethamine)
EXCIPIENT:
Benzyl alcohol
16.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless to pale yellow solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Lutalyse is indicated for its luteolytic and/or oxytocic effects in
cattle. The indications
for use are:
1. To more effectively control the time of oestrus in cycling cows.
2. To treat cows which have a functional corpus luteum, but do not
express
behavioural oestrus (sub-oestrus or silent heat).
3. To induce abortion.
4. To induce parturition.
5. For treatment of chronic metritis and pyometra.
6. For controlled breeding in normally cycling dairy cows:

oestrus synchronisation

ovulation synchronisation in combination with GnRH or GnRH analogues
as
part of fixed time artificial insemination protocols.
4.3
CONTRAINDICATIONS
Do not use in animals suffering from either acute or sub-acute
disorders of the
vascular system, gastro-intestinal tract or respiratory system.
Revised: April 2021
AN: 01269/2020
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Do not use when abortion or parturition is not intended.
Do not administer by the intravenous route.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
For intramuscular use in cattle only. Do not administer more than 2 ml
per single
injection
Lutalyse is ineffective when administered prior to day five after
ovulation.
Administration of Lutalyse to cattle within four days after oestrus is
unlikely to result
in luteolysis of the corpus luteum.
Administration within 48 hours before onset of the next oestrus may
not influence the
timing of the oestrus after treatment.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals

                                
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