ALTRESYN 1 LITER

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
ALTRESYN 4 mg/ml oral solution.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
Active principle:
Altrenogest …………………………..4,00 mg
Excipients:
Butylated hydroxyanisole (E320)…………0,07 mg
Butylated hydroxytoluene (E321) ………0,07 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral solution.
Clear, slightly yellow, odorless solution.
4. CLINICAL DATA
4.1 Target species
Pigs (sexually mature gilts).
4.2 Indications for use, specifying the target species
For heat synchronization in sexually mature gilts.
4.3 Contraindications
Do not administer to pregnant animals or animals with uterine infections.
Do not administer to males.
See section 4.7.
4.4 Special warnings for each target species
They have not been described.
4.5 Special precautions for use
Special precautions for use in animals
Add the veterinary medicinal product to the feed immediately before supplying it.
Discard any remains of unconsumed medicated feed.
Use only in sexually mature gilts that have already been in heat.
Unconsumed medicated feed should be securely destroyed and not fed to
another animal

Special precautions to be taken by the person administering the medicinal product to
animals
Direct contact with the skin should be avoided. When handling the medicine, clothing should be worn.
personal protection (gloves and gowns).
Porous gloves may allow product to pass onto the skin. If the product comes into contact with
skin under the glove, occlusive materials such as latex or rubber gloves may
increase the transcutaneous absorption of the product.
In case of accidental spillage on the skin or in the eyes, rinse immediately with plenty of
Water.
Wash hands after treatment and before eating.
Pregnant women and women of childbearing potential should avoid contact with the product.
or handle it with great care.
People with progesterone-dependent tumors (known or suspected) or with
thromboembolic disorders should not handle the product.
Effects of overexposure: accidental absorption may cause cycle interruption
menstrual flow, uterine or abdominal contractions, increased or decreased bleeding
uterus, pregnancy prolongation or headache.
Avoid direct contact with the skin.
In case of overexposure, seek medical advice.
4.6 Adverse reactions (frequency and seriousness)
Verify that the correct dose is administered daily since underdosing
It can generate the formation of cystic follicles.
4.7 Use during pregnancy, lactation or lay
Do not administer to pregnant or lactating animals.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amounts to be administered and administration route
For oral administration above feed.
20 mg altrenogest/animal, equivalent to 5 mL per animal once daily for 18 days
in a row.
For the 540 and 1080 ml formats:
The product should only be administered with the Altresyn dispenser.
To prime the dispenser:
– hold the container in a horizontal position, the nozzle of the dispenser pointing towards
arriba
– pull the trigger slowly until droplets appear at the tip of the nozzle
From that moment on, the dispenser delivers 5ml doses at each full pressure of the
trigger. For regular administration hold the bottle in an upright position facing down.
The dispenser must remain in the bottle during the entire period of use of the product,
and the closure system must be used for storage between treatments.

For the 360 ​​ml format:
Press and release the dosing pump to deliver a 5 mL dose. Do not shake before
its use to prevent the solution from mixing with the nitrogen included in the container at
Pressure.
Separate the animals and administer the product individually. Add product by
above the feed Add immediately before consuming the feed.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
None known.
4.11 Timeout
Meat: 9 days.
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Sex hormones and modulators of the genital system.
ATCvet code: QG03DX90.
5.1 Pharmacodynamic properties
Altrenogest is a synthetic progestogen belonging to the 19-nortestosterone family. It is an orally active progestin. Altrenogest reduces concentrations
blood levels of endogenous gonadotropins (LH and FSH). As a consequence, it induces a
regression of large follicles (> 5 mm) and does not allow growth of follicles beyond
of 3 mm, giving rise to an absence of heat and ovulation during the treatment. At the end of
treatment there is a regular increase in plasmatic LH concentration allowing the
follicular growth and maturation. The animals appear in heat synchronously.
5.2 Pharmacokinetic data
Altrenogest is rapidly absorbed after oral administration, with a peak of
plasma concentration that is reached between 1 and 4 hours after treatment. He
altrenogest is extensively metabolized in the liver and eliminated by biliary excretion. The
elimination half-life is approximately 14 hours.
6. PHARMACEUTICAL DATA
6.1 List of excipients
Butylated hydroxyanisole (E320)
Butylated hydroxytoluene (E321)
Soy oil
Nitrogen
6.2 Incompatibilities
None known.

6.3 Validity period
Shelf life of the veterinary medicinal product packaged for sale: 3 years.
Shelf-life after opening the primary packaging (for 540 and 1080 ml formats): 2
months
6.4. Special storage precautions
360 ml pressure container: Protect from sunlight and do not expose to temperatures
above 50ºC. Do not pierce or throw into fire, even when empty.
540 and 1080 ml containers: They do not require special storage conditions.
6.5 Nature and composition of immediate packaging
Nature of the 360 ​​ml container:
Aluminum pressure container with dosing valve.
Nature of the 540 and 1080 ml containers:
Aluminum container closed with a polyethylene cap and a polypropylene screw cap.
Formats:
Box with 1 container of 360 ml.
Box with 3 containers of 360 ml.
Container of 540 ml.
Container of 1080 ml.
Not all formats may be marketed.
6.6 Special precautions for disposal of the veterinary medicinal product not
used or, where appropriate, the residues derived from its use
Any unused veterinary medicinal product or residues derived from it must be disposed of
in accordance with local regulations.
7. MARKETING AUTHORIZATION HOLDER
CEVA ANIMAL HEALTH, SA
C/Carabela La Niña, 12
BARCELONA 08017
8. MARKETING AUTHORIZATION NUMBER
1948 ESP
9. DATE OF THE FIRST AUTHORIZATION OR RENEWAL OF THE
AUTHORIZATION
November 12, 2008 / November 17, 2011
10. DATE OF REVISION OF THE TEXT

04 June, 2012

See technical sheet