Fatroximin®

Intramammary ointment.

Antibiotic for Drying Therapy

Each 5 mL syringe tube contains:
Rifaximin…………………………. 0.100 g
Excipients c.s.p…………….. 5 mL

FATROXIMIN,® an intramammary ointment, is indicated in cow drying for the therapy of existing subclinical mastitis, the prevention of possible infection during the dry period and the prevention of acute postpartum mastitis, produced by Gram-positive ( Streptococcus spp., Staphylococcus spp., Corynebacterium spp.) and Gram-negative (E. coli) microorganisms.
It acts on the most common udder microbial species sensitive to Rifaximin, such as: Streptococcus agalatiae, Streptococcus dysgalactiae, Streptococcus uberis, Streptococcus faecalis, Staphylococcus aureus (including penicillin-resistant strains) and Staphylococcus epidermidis.

Cattle: cows in the drying period.

Administer one 5 mL syringe tube of FATROXIMIN®, intramammary ointment, (equivalent to 100 mg of Rifaximin) per quarter of the breast, after the last milking, prior to drying.
Milk the room thoroughly and after disinfection of the nipple hole, then apply FATROXIMIN®, intramammary ointment, inserting the cannula and injecting the entire contents of the syringe.
Afterwards, the nipple should be massaged from bottom to top to diffuse the product throughout the room.

FATROXIMIN®, intramammary ointment is a preparation based on Rifaximin, a new antibiotic obtained by original synthesis, belonging to the Rifamycin family. The particular chemical structure has given the molecule chemical-physical characteristics such that it has a pharmacokinetics that are completely different from the other rifamycins currently on the market. The studies carried out reveal a practically non-existent passage through the intramammary epithelium, allowing an optimal availability of Rifaximin at the level of the fourth treated.
FATROXIMIN®, intramammary ointment, has a high bactericidal antibacterial activity against Gram-positive (Streptococcus spp., Staphylococcus spp., Corynebacterium spp.) and Gram-negative (E. coli) microorganisms.
It acts on the most common microbial species in the udder.

FATROXIMIN®, intramammary ointment has intramammary syringes with the “Twinsert” system.
The “Twinsert” system allows a partial and also a complete insertion of the antimastitic syringe cannula into the nipple canal according to the operator’s requirements.
Recent studies show that antimastitic treatment through a partial insertion of the cannula into the nipple canal significantly reduces the flare-up of
new breast infections.
In fact, the complete insertion of the cannulas dilates the nipple sphincter making it easier for bacteria to enter, and at the same time, it can transport the bacteria present
in the keratin layer, lining the nipple orifice, directly to the nipple cistern.

FATROXIMIN®, intramammary ointment, is prepared in such a way that it has a high stability and a constant viscosity to the variation of temperature
environmental.
FATROXIMIN®, ointment for intramammary drying is perfectly tolerated, does not irritate the udder or produce any type of reactions. The presence of the vehicle results in an immediate and complete distribution of the active ingredient.
FATROXIMIN®, a properly applied intramammary ointment, remains on the udder throughout the drying period and is eliminated in the colostrum, so that the milk from the first milking does not contain residues of the antibiotic.

Field tests have shown:

• A high therapeutic activity, with bacteriological negativization of the rooms subjected to treatment and previously found infected by Streptococcus agalatiae, Streptococcus dysgalactiae, Streptococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, some penicillin resistant strains.
• A consequent preventive action, especially in secretory disorders of the breasts, that is, those pathophysiological situations characterized by a high cell content with the absence of pathological microorganisms in the milk.

• Do not administer in animals with hypersensitivity to Rifaximin.
• Do not administer to lactating cows.
• Do not administer to cows with clinical mastitis.

• Keep out of reach of children.
• Antimastytic treatment through a partial insertion (a few millimeters in the nipple canal) of the cannula into the nipple canal reduces the probability of new breast infections, as it prevents dilation of the sphincter, destruction of the keratin layer and also deposits antibiotics along the nipple canal.
• If there are lesions on the nipple, or if the animals are very nervous, the complete insertion of the cannula can make the work easier.

• Do not handle by people who are hypersensitive to Rifaximin.
• Do not smoke, eat or drink during handling and administration of the product.
• Avoid contact with skin, eyes, or mouth.
• Use of gloves when administering the product.
• Wash your hands after administering the product.
• In case of accidental ingestion, go immediately to a medical center and show the product label.
• In case of contact with skin, eyes or mouth, wash immediately with plenty of running water.
• In case of skin irritation, go immediately to a medical center and show the product label.

Empty containers can be discarded as household waste, without any special precautions.
Do not dispose of containers with product residues on the ground or in waterways.
Contact the importing company or companies specialized in waste disposal, to receive recommendations on the disposal of expired or unused products.

Meat: Zero days.
Milk: Zero days.
Treatment should be done at least 42 days before the scheduled delivery; Under these conditions, no shelter period is required.
In the event of premature birth, do not use the milk from 18 consecutive milkings for human consumption.

Store at a temperature between 2 and 30°C, in a cool, dry place, away from light.

Sale by prescription to the Veterinary Doctor.

FRACTIONAL SALE FORBIDDEN
VETERINARY USE

Reg. SAG No. 2075-B

Box with 12 tubes-syringes of 5 mL

FATRO S.p.A.
Via Emilia, 285
40064 Ozzano, Emilia (Bologna), Italy.

Laboratorio Drag Pharma Chile Invetec S.A.
Lautaro N° 300. Quilicura. Santiago. Chile.

Licensed by FATRO S.p.A. – Italy