Genestran
Genestran is a natural Prostaglandin.
Genestran is licensed for mares, cattle and pigs.
Genestran contains the purified D-isomer Cloprostenol.
The purified D- isomer is the only isomer that binds to the receptor sites, greatly enhancing its beneficial effects and reducing unwanted side effects.
Each ml of Genestran contains 75 micrograms of pure D-Cloprostenol.
Species: Cattle, Horses and Pigs
Active(s): D Cloprostenol 75µg/ml
Pack Size: 20ml
Legal Category: POM-V (UK), POM (IE)
Genestran is licensed for the following indications in mares:
Induction of luteolysis in mares with a functional corpus luteum.
The recommended dose rate of Genestran for mares is 0.3-0.5ml
4.1 Target species
Cattle, horses and pigs.
4.2 Indications for use, specifying the target species
Cattle:
- induction of luteolysis allowing resumption of oestrus and ovulation in cyclic females when
used during dioestrus
- synchronisation of oestrus (within 2 to 5 days) in groups of cyclic females treated
simultaneously
- treatment of suboestrus and uterine disorders related to a functioning or persistent
corpus luteum (endometritis, pyometra)
- treatment of ovarian luteal cysts
- induction of abortion until day 150 of pregnancy
- expulsion of mummified foetuses
- induction of parturition (within the last two weeks of gestation).
Horses:
- induction of luteolysis in mares with a functional corpus luteum.
Pigs:
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AN: 01179/2016
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- induction or synchronisation of farrowing (generally within 24 to 36 hours) from day 113 of
pregnancy onwards (day 1 of pregnancy is the last day of natural or artificial insemination).
4.3 Contraindications
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals with spastic respiratory or gastro-intestinal diseases.
Do not use in pregnant animals, for which induction of abortion or parturition is not intended.
Do not use for intravenous administration.
4.4 Special warnings for each target species
None.
4.5 Special precautions for use
Special precautions for use in animals:
To reduce the risk of anaerobic infections, which might be related to the pharmacological
properties of prostaglandins, care should be taken to avoid injection through contaminated
areas of skin. Clean and disinfect injection sites thoroughly before application.
Avoid contamination of the product during use. Should any apparent growth or discoloration
occur, the product should be discarded.
Pigs: use only when precise date of insemination is known. Administer on day 113 of
gestation, at the earliest. The product administered earlier, may impair the viability and
weight of piglets.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
The product must be handled carefully to avoid accidental self-injection and direct contact
with the skin or mucous membranes of the user.. Prostaglandins of the F2a type may be
absorbed through the skin and may cause bronchospasm or miscarriage. Pregnant women,
women of childbearing age, asthmatics and persons with other respiratory tract diseases
should exercise caution when handling cloprostenol. Those persons should wear gloves
during administration of the product. Accidental spillage on the skin should be washed
immediately with soap and water. In case of accidental self-injection, seek medical advice
immediately and show the package leaflet or the label to the physician. Should respiratory
distress result from accidental inhalation or injection, a rapid acting bronchodilator, e.g.
isoprenaline or salbutamol by inhalation is indicated.
4.6 Adverse reactions (frequency and seriousness)
Anaerobic infections may occur if anaerobic bacteria are introduced into the tissue by the
intramuscular injection.
Cattle:
Following induction of parturition with the product, an increased incidence of placental
retention may be observed.
Horses:
After an injection of the product, slight sweating and diarrhoea may develop temporarily.
Pigs:
No undesirable effects have been reported.
4.7 Use during pregnancy, lactation or lay
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AN: 01179/2016
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Pregnancy:
Do not use in pregnant animals, for which induction of abortion or parturition is not intended.
Lactation:
Can be used during lactation.
4.8 Interaction with other medicinal products and other forms of interaction
Concurrent use of oxytocin and cloprostenol increases the effects on the uterus.
4.9 Amounts to be administered and administration route
For intramuscular administration only
Cattle:
2.0 ml (150 µg).
Induction of oestrus: two days following administration, close observation of the
oestrus is advised.
Synchronisation of oestrus: animals are to be treated twice within 11 days.
Horses:
0.3- 0.5 ml (22.5 - 37.5 µg)
Intended for single use.
Pigs:
0.7- 1.0 ml (52.5 - 75 µg)
Intended for single use.
The stopper should not be pierced more than 70 times.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No specific antidote exists for R(+)- cloprostenol. For cattle and pigs no cases of overdosage have been recorded. An overdose of R(+)- cloprostenol in the horse may lead to
transient diarrhoea, increased sweating around the neck and slight decrease in body
temperature.
4.11 Withdrawal period(s)
Cattle and horses
Meat and offal: 1 day
Milk: zero hours
Pigs
Meat and offal: 1 day
5. PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: prostaglandin-F2a–agonist
ATCvet code: QG02AD90
5.1 Pharmacodynamic properties
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AN: 01179/2016
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Genestran contains the active substance R(+) - cloprostenol, the biologically active
component of the synthetic prostaglandin cloprostenol which acts similarly to the naturally
occurring endogenous PGF2a.
Since Genestran contains only the biologically active component R(+) - cloprostenol, low
doses are sufficient to produce luteolytic and/or stimulatory effects on the myometrium.
5.2 Pharmacokinetic particulars
Cloprostenol is reabsorbed rapidly. As demonstrated in cattle, highest plasma
concentrations (Tmax) are reached within one hour and decline with a t½ of between 40 to
80 minutes. Elimination occurs in the urine and faeces.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Chlorocresol
Citric acid monohydrate
Sodium hydroxide (for pH adjustment)
Water for Injections
6.2 Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be
mixed with other veterinary medicinal products.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.
6.4 Special precautions for storage
Keep the vial in the outer carton in order to protect from light.
6.5 Nature and composition of immediate packaging
Colourless vials of type I glass containing 20 ml or 50 ml of solution for injection, with
chlorobutyl rubber stoppers and aluminium caps.
Presentations:
Cardboard box of 1 vial of 20 ml or 50 ml
Cardboard box of 5 vials of 20 ml
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product or
waste materials
Any unused veterinary medicinal product or waste materials derived from such veterinary
medicinal product should be disposed of in accordance with local requirements.
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