Dragpharma

Species

Bovines (cows in dry period).

Dosage form

Intramammary ointment.

Therapeutic action

Antimastitic for drying treatment

Composition

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

Properties

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 such chemical-physical characteristics that it has a pharmacokinetic that is completely different from the other rifamycins currently on the market.
The studies carried out reveal a practically null passage through the intramammary epithelium, allowing optimal availability of Rifaximin at the level of the fourth treated.
FATROXIMIN^®, intramammary ointment has a high antibacterial activity of the bactericidal type against Gram positive microorganisms (Streptococcus spp., Staphylococcus spp., Corynebacterium spp.) And Gram negative ones (E. coli).
It acts on the most frequent microbial species in the udder.

Indications

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

Effectiveness

CLINICAL EFFECTIVENESS
Field tests have shown:

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

Route od administration and dosage

Intramammary route of administration

• Administer a 5 mL syringe tube of FATROXIMIN^®, intramammary ointment, (equivalent to 100 mg of Rifaximin) per breast quarter, after the last milking, prior to drying.
• Milk the quarter thoroughly and after disinfecting the nipple orifice, then apply FATROXIMIN^®, intramammary ointment, introducing the cannula and injecting the entire contents of the syringe.
• Subsequently, the nipple should be massaged from the bottom up to spread the product throughout the room.

Contraindications

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

Special precautions for use

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

• Keep out of the reach of children.
• Antimastitic treatment through a partial insertion (a few millimeters in the nipple canal) of the cannula in the nipple canal reduces the probability of new breast infections, since it prevents the dilation of the sphincter, the destruction of the keratin layer and also , deposits antibiotic along the nipple canal.
• If there are injuries to the nipple, or if the animals are very nervous, the complete insertion of the cannula can facilitate the work.

Special precautions for the operator

• Do not handle by people who are hypersensitive to Rifaximin.
• Do not smoke, eat or drink during the handling and administration of the product.
• Avoid contact with skin, eyes, or mouth.
• Use of gloves when administering the product.
• Wash hands after administering the product.
• In case of accidental ingestion, immediately go 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.

Guard period

Meat: 0 days.

Milk: 0 days.

Treatment must be done at least 42 days before scheduled delivery; under these conditions, no protection period is required.
In the event of premature delivery, do not use the milk from 18 consecutive milkings for human consumption.

Observations

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL

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

Conservation

Store the product between 2º and 30ºC, in a cool and dry place, protected from light.

Product origin

Italy

Condition of sale

Sale with Veterinary Medical prescription.

Presentation

Case with 12 syringe tubes of 5 mL each.

Prepared by

Fatro S.p.A.- Italia.

Records

Reg. SAG Nº 2075-B