Revised: 03 September 2008
AN: 01627/2007
SUMMARY OF PRODUCT CHARACTERISTICS
- NAME OF THE VETERINARY MEDICINAL PRODUCT
GABBROSTIM INJECTION, 2 mg/ml, solution for injection
2.Quantitative and Qualitative Composition
1 ml of product contains:
Active substance
Alfaprostol 2 mg
For a full list of excipients, see section 6.1.
- Pharmaceutical Form
Solution for injection.
A clear, colourless, slightly-yellowish liquid.
- Clinical Particulars
4.1Target species
Cattle: Cows and heifers
Pigs: Sows
Horses: Mares
4.2Indications for use specifying the target species
Cows and heifers:Induction and synchronisation of heat in cows and heifers with known previous oestrus dates.
Induction and synchronisation of heat in cows and heifers with unknown previous oestrus dates.
Induction of parturition.
Anoestrus due to a persistent corpus luteum or luteinic cysts.
Silent heat (sub-oestrus).
Pyometra (chronic endometritis).
Mummified foetus.
Sows:Induction of parturition.
Mares: Stimulation of heat in normally cycling mares.
Postpartum stimulation of heat.
Mares in anoestrus.
4.3 Contra-indications
Do not administer to pregnant animals, except when parturition or therapeutic abortion is required.
4.4 Special warnings for each target species
Close attention should be given to cows and heifers during treatment for mummified foetus, as manual assistance may be necessary. Careful aseptic techniques should be employed to decrease the likelihood of post-injection bacterial infection. If signs of infection are noticed post-injection, immediate antibiotic therapy should be instigated.
4.5Special precautions for use, including special precautions to be taken by the person administering the medicinal product to the animals
i) Special precautions for use in animals
None known.
ii) Special precautions to be taken by the person administering the medicinal product to animals:
Prostaglandins of the F2 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.
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.
Should shortness of breath result from accidental inhalation or injection, seek urgent medical advice and show the doctor this warning.
Accidental spillage on the skin should be washed off immediately with soap and water.
Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
Mild and transient sweating may occur in mares.
4.7 Use during pregnancy, lactation or lay
Do not administer to pregnant animals, except when parturition or therapeutic abortion is required.
Gabbrostim may be used safely during lactation.
4.8 Interaction with other medicinal products and other forms of interaction
Do not carry out treatment concomitantly with non-steroidal antiinflammatory drugs, as these inhibit endogenous prostaglandin synthesis.
4.9 Amounts to be administered and administration route
A single dose of the product should be administered by deep intramuscular injection.
An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes. Swab the septum before removing each dose. Care should be taken to avoid injection through wet or dirty areas of the skin. Use a dry, sterile needle and syringe when dosing each of a group of animals, or a draw-off needle must be used.
Cows and heifers: 0.75 ml per 100 kg b.w. (equivalent to 1.5 mg of alfaprostol/kg of body weight) with a maximum of 4 ml whatever the weight of the animal.
Induction and synchronisation of heat (known previous oestrus dates): Administration during the phase in which the corpus luteum is sensitive (days 5 to 17 of the oestrus cycle) causes onset of heat and ovulation within 2 to 4 days.
Induction and synchronisation of heat (unknown previous oestrus dates): Give all cows/heifers one dose, and inseminate any seen in heat 2 to 5 days following injection. Those not seen in heat should be given a second injection 10 to 12 days after the first dose.
Induction of parturition: Pregnant cows and heifers at term (279 to 289 days) respond by expelling the foetus 18 to 36 hours after injection.
Anoestrus due to persistent corpus luteum or luteinic cysts: Administration causes onset of heat, with ovulation, 2 to 4 days after the injection.
Silent heat: Treatment is recommended, especially after rectal diagnosis of a palpable corpus luteum, followed by double insemination at 72 and then 96 hours after injection.
Pyometra: A single injection causes luteal regression, a return to normal cycling and resultant voiding from the uterus. If necessary give a second injection 10 to 12 days after the first.
Mummified foetus: Administration normally causes expulsion of the mummified foetus within 2 to 4 days, with the onset of heat. Close attention should be given to animals during this treatment as manual assistance may be necessary.
Sows: 1 ml (equivalent to 2 mg of alfaprostol) per animal, administered on day 111 or 112 of pregnancy. Parturition usually occurs between 18 and 36 hours after injection.
Mares: 1.5 ml (equivalent to 3 mg of alfaprostol) per animal.
Stimulation of heat in normally cycling mares: Treatment during the sensitive phase of corpus luteum (i.e. from the fifth day after ovulation) brings mares into oestrus within 2 to 4 days, followed by ovulation 6 to 8 days after injection.
4.10 Overdose (symptoms, emergency procedures, antidotes) if necessary
In mares, high doses may cause transient sweating and loose faeces. No antidote is available or known.
4.11 Withdrawal periods
Cattle – Meat: 4 days
Milk:24 hours
Pigs – Meat:4 days
Horses– Meat:4 days
5PHARMACOLOGICAL PROPERTIES:
5.1Pharmacodynamic properties
ATC vet Code: QG02AD94
Alfaprostol is a synthetic prostaglandin F2 analogue with specific luteolytic activity (i.e. it causes lysis of the corpus luteum whether persistent or associated with either the normal cycle or pregnancy).
5.2 Pharmacokinetic particulars
Injection of 14C-alfaprostol in propylene glycol vehicle results in rapid distribution throughout the body with a Tmax in blood of 0.75 h and Cmax of 2.73 ng/ml in cows, a Tmax of 0.5 h and Cmax of 22.3 ng/ml in sows and a Tmaxof 2.0 h and Cmax of
2.30 ng/ml in mares. The elimination half-lives are 8, 3 and 6 h for cows, sows and mares respectively.
The first step in metabolism is de-esterification to form alfaprostol acid, followed by -oxidation to give dinor-5, 6-dihydro-alfaprostol acid and tetranor-alfaprostol acid; these two latter metabolites were found to be 100 times less potent than the parent compound. Faeces and urine are the main routes of elimination of alfaprostol and its metabolites.
6PHARMACEUTICAL PARTICULARS
6.1List of excipients
Propylene glycol.
6.2 Incompatibilities
None known.
6.3Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.
6.4Special precautions for storage
Do not store above 25C.
Keep vial in outer carton in order to protect from light.
6.5 Nature and Composition of Immediate Packaging
20 ml and 40 ml, colourless glass Type I vials, with a rubber bromobutyl bung and an aluminium overseal. The secondary packaging is a cardboard box, which contains a single vial of either 20 ml or 40 ml.
Not all pack sizes may be marketed.
6.6Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7.Marketing authorisation holder
CEVA VETEM S.p.A.
Via Colleoni 15
20041 Agrate Brianza (MI)
ITALY
8. Marketing authorisation number(s)
Vm 28350/4000
9. Date of the first authorisation
Date of first authorisation 18 October 1999
10. Date of revision of the text
September 2008