NAM PHUC THINH TRADING CO., LTD

SUIFERTIL

1 ml contains:
Active substance:
Altrenogest ...........................4.00 mg
PHARMACEUTICAL FORM
Oral solution.
4. CLINICAL PARTICULARS
4.1. Target species
Pigs (sexually mature gilts and sows for reproduction).
4.2. Indications for use, specifying the target species
Synchronisation of oestrous in sexually mature gilts and sows for reproduction.
4.3. Contraindications
Do not use in boars.
Do not administer to pregnant sows (see section 4.7) or those suffering from
uterine infection.
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
4.4. Special warnings for each target species
None.
4.5. Special precautions for use
Special precautions for use in animals
Use in sexually mature gilts that have had at least one oestrous cycle.
Ensure the correct dose is administered daily as under dosing can lead to the
formation of cystic follicles.
In case to add the product as a top dressing to the feed, add it immediately before
feeding. Part consumed feed must be safely disposed and not given to any other
animals.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Direct contact with the skin should be avoided.
Personal protective clothing (gloves and overalls) must be worn when handling
the product. Porous gloves may let this product pass through to the skin. If the
product makes contact with the skin underneath the glove, occlusive materials
such as latex or rubber in gloves may enhance transcutaneous absorption of the
product.
Accidental spillage on the skin or eyes should be washed off immediately with
plenty of water.
Wash hands after treatment and before meals.
Pregnant women and women of childbearing age should avoid contact with the
product or should exercise extreme caution when handling this product.
People suffering from progesterone dependent tumours (known or suspected) or
from thromboembolic disorders should not use the product.
People with known hypersensitivity to the active substance should avoid contact
with the product.
Over-exposure effects: Accidental absorption could lead to disruption of the
menstrual cycle, uterine or abdominal cramping, increased or decreased uterine
bleeding, prolongation of pregnancy or headache. In case of over-exposure, seek
medical advice.
Direct contact with the skin should therefore be avoided.
Other precautions regarding impact on the environment
When spreading manure from treated animals, the minimum distance to surface
water as defined in the national or local regulations has to be strictly respected,
because the manure may contain altrenogest which could cause adverse effects
in the aquatic environment.
4.6. Adverse reactions (frequency and seriousness)
None known.
4.7. Use during pregnancy, lactation or lay
Do not use during pregnancy.
4.8. Interaction with other medicinal products and other forms of
interaction
Griseofulvin may alter the effects of altrenogest when administered concurrently
with this product.
4.9. Amounts to be administered and administration route
For oral use as a top-dressing or directly into the mouth of the animal.
Gilts: 5 ml/animal (equivalent to 20 mg of altrenogest), 18 consecutive days.
Sows: 5 ml/animal (equivalent to 20 mg of altrenogest), 5 consecutive days.
Oestrus occurs 5 to 6 days after treatment period.
Animals should be segregated and dosed individually.
In case to add the product as a top dressing to the feed, add it immediately before
feeding. Discard any uneaten medicated feed.
4.10.Overdose (symptoms, emergency procedures, antidotes), if necessary
None known.
4.11.Withdrawal period
Meat and offal: 9 days
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years.
Shelf-life after first opening the immediate packaging: 3 months.