Lutalyse 5 mg/ml Solution for Injection
Active ingredient: Dinoprost
Form
Injection
Species
Manufacturer
Zoetis Belgium S.A.
VMD MA No.
60021/3017
What it's used for
Lutalyse is indicated for its luteolytic and/or oxytocic effects in cattle, horses and pigs. The indications for use are: Cattle 1. To more effectively con...
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Lutalyse 5 mg/ml Solution for Injection — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
pigs. The indications for use are:
Cattle
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
-
analogues as part of fixed time artificial insemination protocols
Mares
1. To more effectively control the time of oestrus in cycling mares.
Revised November 2024
AN: 01967/2024
2. To treat mares which have a functional corpus luteum but do not express
behavioural oestrus.
3. To induce abortion.
Pigs
1. Induction of parturition
2. To reduce the weaning to oestrus interval (WOI) and the weaning to
fertile service interval (WFSI) in sows in herds with reproductive
problems.
provided a functional corpus luteum is present.
Administer by intramuscular injection. Full aseptic precautions must be taken.
Use a sterile syringe and needle and make the injection through an area of
clean dry skin. Care should be taken to avoid injection through wet or dirty
areas of skin.
Cattle
The dose for all indicated uses in cattle is 5 ml Lutalyse (25 mg dinoprost)
Mares
The dose for all indicated uses in mares is 1 ml Lutalyse (5 mg dinoprost)
Pigs
Induction of parturition: 2 ml Lutalyse (10 mg dinoprost) within 72 hours of
expected parturition.
Use post-partum: 2 ml Lutalyse (10 mg dinoprost) 24 to 48 hours after
parturition.
NOTES
1. Oestrus control in cycling cattle and horses.
Individual
and ovulate within two or four days after treatment.
Mares
days and ovulate 8 to 10 days after treatment.
This may be employed to advantage as an effective aid towards managing
oestrus and breeding in individual animals. (Note: Administration of Lutalyse to
cattle and horses 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).
Revised November 2024
AN: 01967/2024
2. Treatment of sub-oestrus (no visible oestrus) in cattle and horses.
Individual
behavioural oestrus; this occurs most frequently in the winter months, at peak
lactation in high producing dairy cows and in suckler beef cows. If a corpus
luteum is present and ovulation has not occurred in the previous four days,
administration of Lutalyse will result in corpus luteum regression followed by
return to oestrus and ovulation.
Breeding of cattle treated with Lutalyse for the above indication may be by natural
service, artificial insemination at the usual time in relation to observed oestrus, or
by fixed time insemination (78 hours or 72 and 90 hours post-treatment).
In extended dioestrus in mares
distinct from true anoestrus. Many mares described as anoestrual during the
breeding season have serum progesterone levels consistent with the presence of
a functional corpus luteum.
A proportion of 'barren', maiden and lactating mares do not exhibit regular oestrus
cycles and may be in extended dioestrus. Following abortion, early foetal death
and resorption, or as a result of 'pseudo-pregnancy' there may be serum
progesterone levels consistent with a functional corpus luteum.
Treatment of such mares with Lutalyse usually results in regression of the corpus
luteum followed by oestrus and/or ovulation.
3. Induction of abortion in cattle and mares.
Lutalyse may be used to terminate pregnancy in cattle and mares through its
luteolytic effect during those stages of pregnancy in which the corpus luteum is
sensitive to its action and in which maintenance of pregnancy is dependent upon
the corpus luteum as the sole source of progesterone.
Stage of gestation in
percentage of animals responding to a single intramuscular injection decreases
as the gestation period increases. Approximate percentage responding are 90%
within the first 100 days of gestation, 60% within 101-150 days of gestation and
40% in animals beyond 150 days of gestation. In the early stages of gestation,
abortion will usually occur within one week, but as gestation length increases, the
period to abortion following injection may also increase.
In
abortion; response to treatment between days 40 and 90 of gestation is less
predictable, possibly due to PMSG secretion from the endometrial cups rendering
the corpus luteum refractory to the luteolytic effect of Lutalyse. Between days 90
and 120 of pregnancy luteal regression may lead to abortion.
4. Induction of parturition in cattle and pigs.
Cattle
gestation. The interval from administration to parturition is one to eight days
Revised November 2024
AN: 01967/2024
(average three days). Induction of parturition in cattle is indicated where there is a
risk of oversize calves or where early parturition is desired. In addition, induction
is indicated where pregnancies are complicated by miscellaneous conditions
such as mummified or macerated foetuses, hydrops amnii, hydroallantois, etc.
Lutalyse is indicated for expulsion of a dead foetus.
Pigs
normal predicted farrowing date. Response to treatment by individual animals
varies within a range of 24-36 hours from administration to parturition. This can
be advantageously employed to control the time of farrowing in sows and gilts in
late gestation. Treatment earlier than 3 days prior to predicted farrowing date
may produce weak piglets resulting in reduced survival. It is recommended that
treatment be given in the early morning following feeding. A lack of response has
been noted in a small proportion of pigs, the specific reason for which has not yet
been determined.
5. Treatment of metritis or pyometra in cattle.
In the
endometritis in the first two or three weeks post-partum; typically, there is an
intermittent purulent or mucopurulent discharge. Pyometra is characterised by the
retention of purulent fluid within the uterus.
Luteal regression through the administration of Lutalyse is followed by oestrus,
during which the uterine environment is relatively unfavourable to the bacteria
involved in the infection. Treatment may have to be repeated after 10-12 days
where the condition is long standing.
6. Controlled breeding in cattle.
Lutalyse is indicated for its luteolytic effect in
utilised to control the timing of oestrus in cycling cattle that have a corpus luteum.
For normally-cycling cows, at least 35 days after calving, the identified activity of
Lutalyse permits a wide range of oestrus control programmes.
Programme I
1. Inject 5 ml Lutalyse intramuscularly;
2. Repeat the injection in 11 (10 to 12) days; then,
3. Inseminate 78 (75 to 80) hours after the second Lutalyse injection. No
oestrus detection or observation is required if animals were cycling normally
when injected.
This programme is recommended for most herds with successful A.I
experience where females are known to be cycling.
Programme II
1. Inject 5 ml Lutalyse intramuscularly;
2. Repeat the injection in 11 (10 to 12) days; then,
Revised November 2024
AN: 01967/2024
3. Inseminate 72 (70 to 74) hours and 90 (88 to 96) hours after the second
Lutalyse™ injection. No oestrus detection or observation is required if
animals were cycling normally when injected.
Double insemination has demonstrated increased pregnancy rates in some
herds.
Programme III
a
1. Inject 5 ml Lutalyse intramuscularly;
2. Repeat the injection in 11 (10 to 12) days; then,
3. Inseminate upon detected oestrus.
Programme IV
a
1. Inject 5 ml Lutalyse intramuscularly;
2. Inseminate upon detected oestrus.
a
If it is unknown whether most animals to be treated are cycling,
Programmes III and IV calling for oestrus detection should be followed rather
than Programmes I and II calling for timed insemination. A "clean-up bull" may be
used following any Lutalyse programme, or the service may be repeated at the
next oestrus, one cycle later, in animals that did not conceive at first service.
Practical application of these programmes will vary depending upon many
factors, and in many cases these programmes may be altered to meet the
requirements of the specific operation. For example, some veterinary surgeons
may wish to design their own programmes for specific situations and schedules.
The activity of Lutalyse may be easily adapted for such individualised approach.
These changes should be carefully evaluated to ensure that they do not
detrimentally affect the success of the breeding programme.
Programme V
Lutalyse may be used as part of a fixed time artificial insemination protocol to
synchronise ovulation for normally-cycling dairy cows at any stage of lactation.
The following protocols have been commonly reported in the literature:
•
•
•
•
Alternatively:
•
•
•
observed oestrus if sooner.
Revised November 2024
AN: 01967/2024
To maximise conception rates of cows to be treated, the ovarian status should be
determined and regular cyclic ovarian activity confirmed. Optimal results will be
achieved in healthy normally-cycling cows.
7. To reduce the weaning to oestrus interval (WOI) and the weaning to
fertile service interval (WFSI) in sows in herds with reproductive
problems.
PGF2 has a stimulating effect on uterine contractions, leading to better post-
partum evacuation of the uterus. Field clinical trials in herds with reproductive
problems have confirmed that treatment with Lutalyse may result in a more rapid
return to oestrus and fertile service after farrowing.
GENERAL NOTES
Many factors contribute to the success and failure of reproduction management,
and these are important when the time of breeding is to be regulated with
Lutalyse. Some of these factors are:
1. Cattle and mares must have a corpus luteum on the ovary of about five
days or more of age in order for Lutalyse to be luteolytic, i.e. they are
healthy and are undergoing normal oestrus cycles.
2. Semen of high fertility must be inseminated.
3. Semen must be inseminated properly.
4. Oestrus must be detected accurately if timed AI is not employed.
5. Physical facilities must be adequate to allow cattle handling without being
detrimental to the animal.
6. Nutritional status must be adequate prior to and during the breeding
season as this has a direct effect on conception and the initiation of
oestrus in heifers or return of oestrus cycles in cows following calving.
the vascular system, gastro-intestinal tract or respiratory system. Contra-
indicated when abortion or parturition is not intended.
Do not administer by the intravenous route.
The most frequently observed side-effect is increased rectal temperature at a 5x
or 10x overdose. However, rectal temperature changes have been transient in
all cases observed and have not been detrimental to the animal. Limited
salivation has been seen in some instances.
Localized post injection bacterial infections that may become generalized have
been reported. Aggressive antibiotic therapy, particularly covering clostridial
species, should be employed at the first sign of infection. Careful aseptic
techniques should be employed to decrease the possibility of post injection
bacterial infections.
Horses
The most frequently observed side-effects are sweating and decreased rectal
temperatures. However, these have been transient in all cases observed and
have not been detrimental to the animal. Other reactions seen have been
increase in heart rate, increase in respiration rate, some abdominal discomfort,
locomotor incoordination and lying down. These effects are usually seen within
15 minutes of injection and disappear within one hour. Mares usually continue
to eat during the period of expression of side-effects.
Pigs
Transient side-effects consisting of increased body temperature, increased
respiratory rate, increased salivation, stimulation of defaecation and urination,
flushing of the skin and restlessness (arching of back, pawing, and rubbing and
gnawing the crate) occur occasionally following the administration of dinoprost
in pregnant sows and gilts. These effects tend to parallel the signs exhibited by
sows prior to normal parturition, only they appear to be condensed in time.
These effects are usually seen within 15 minutes of injection and disappear
within one hour.
Revised November 2024
AN: 01967/2024
generalized have been reported. Aggressive antibiotic therapy, particularly
covering clostridial species, should be employed at the first sign of infection.
Careful aseptic techniques should be employed to decrease the possibility of
post injection bacterial infections.
(i) Special precautions for use in animals
1. Localized post injection bacterial infections that may become
generalized have been reported. Aggressive antibiotic therapy,
particularly covering clostridial species, should be employed at the
first sign of infection. Careful aseptic techniques should be
employed to decrease the possibility of post injection bacterial
infections.
2. Animals should not be treated if they suffer from either acute or
sub-acute disorders of the vascular system, gastro-intestinal tract
or respiratory system.
3. Pregnancy status should be determined prior to injection since
Lutalyse has been demonstrated to result in abortion or parturition
induction when administered at sufficiently high doses to many
animal species.
4. Lutalyse is ineffective when administered prior to day five after
ovulation.
5. If pregnant, the unlikely possibility of uterine rupture should be
borne in mind, especially if cervical dilation does not occur.
6. Induction of parturition in pigs earlier than 72 hours prior to
predicted farrowing date may result in reduced piglet viability.
Revised November 2024
AN: 01967/2024
(ii) Special precautions to be taken by the person administering the
veterinary medicinal product to animals
1. Prostaglandins of the F2 type can be absorbed through the skin
and may cause bronchospasm or miscarriage.
2. Care should be taken when handling the product to AVOID
SELF-INJECTION or SKIN CONTACT.
3. Women of child-bearing age, asthmatics and persons with
bronchial or other respiratory problems should avoid contact
with, or wear disposable plastic gloves when administering, the
product.
4. Accidental spillage on the skin should be washed off immediately
with soap and water.
5. Wash hands after use.
°
C. Following withdrawal of the first dose, the product
should be used within 28 days. Discard unused material. Avoid the introduction
of contamination during use.
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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