Ultrafil® Plus

Acoustic suspension.

Antibacterial – Antifungal – Anti-inflammatory – Acaricidal.

Dogs and cats.

Ultrafil® Plus is a pharmacological combination of Gentamicin, Clotrimazole, Betamethasone and Thiabendazole, which give it antibacterial, antifungal, anti-inflammatory and acaricidal properties.

• Gentamicin is a bactericidal aminoglycoside antibiotic with good activity against a variety of bacteria, especially gram-negative aerobic bacilli. Gentamicin works by inhibiting normal protein synthesis in susceptible bacteria.
  Specifically, Gentamicin is active against organisms commonly isolated in otitis cases, such as: Staphylococcus spp., Streptococcus spp., Pseudomona aeruginosa, Proteus spp., and Escherichia coli, among others.
• Clotrimazole is an imidazolic antifungal agent, which is used in the treatment of infections caused by several species of pathogenic dermatophytes, fungi and Malassezia sp. Its action affects the synthesis of essential components of the fungal plasma membrane, consequently affecting its growth and division.
  In vitro studies have shown its activity against Candida spp., Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis and Malassezia pachydermatis.
• Betamethasone is a long-acting synthetic glucocorticoid. It has an anti-inflammatory potency 25 times more potent than hydrocortisone, and has no mineralocorticoid activity. Its action decreases or prevents tissue responses to inflammatory processes in such a way that it reduces the symptoms of inflammation without affecting the underlying cause.
• Thiabendazole is a benzimidazole agent, with antiparasitic, antifungal and acaricidal activity.
  Its action occurs through the inhibition of the enzyme Fumarate Reductase blocking mitochondrial function, generating an inability to obtain energy, and causing the death of the parasite.
  In addition, benzimidazoles in general bind to Tubulin, blocking the polymerization of Tubulin to microtubules, consequently damaging the integrity and transport functions of parasitic cells. Studies have proven its excellent activity against the mite Otodectes cynotis in cases of otitis in dogs and cats.

Each mL of suspension contains:
Gentamicin Sulfate.. ……………………… 5.09 mg
(Equivalent to 3.0 mg of Gentamicin base)
Betamethasone Dipropionate.. ……..…… 1.29 mg
(Equivalent to 1.0 mg of Betamethasone base)
Clotrimazole.. ……………………………………… 10 mg
Thiabendazole.. ……………………………….…… 40 mg
Excipients c.s.p.. ……………………..………… 1 mL

Ultrafil® Plus, an ear suspension, is indicated in the treatment of otitis externa caused by bacteria, fungi and/or mites sensitive to the association. Its use is especially indicated in ear infections generated by bacteria such as Staphylococcus spp., Streptococcus spp., Pseudomona aeruginosa, Proteus spp. and Escherichia coli; fungi such as, Malassezia pachydermatis, Candida spp. and Microsporum canis, and/or mites of the species Otodectes cynotis.

Topical administration by instillation into the ear canal.

Shake before use. Clean and dry the ear canal prior to product application. Remove all foreign material such as exudate, cellular detritus, etc. Trim excess hair from the area to be treated. Verify the integrity of the tympanic membrane. Instill 3 to 5 drops of Ultrafil® Plus into the ear canal to be treated, once a day, for 7 consecutive days.

• Ultrafil® Plus is contraindicated in patients with hypersensitivity to any of its components.
• Do not use in patients presenting with tympanic perforation.
• Do not use in conjunction with drugs that may induce ototoxicity.
• Do not administer during pregnancy and lactation.
• Do not administer to breeding animals.

• Before starting treatment, the identification of the etiological agent(s) should be carried out, either by smear or culture. In addition, the antibiotic susceptibility of pathogenic bacteria should be evaluated before using this preparation.
• Before instilling any medication into the ear, examine the external ear canal to ensure that there is no rupture of the tympanic membrane, in order to avoid contamination of the middle ear, as well as vestibular and cochlear lesions.
• The Dachshund breed may be particularly sensitive to treatment with Thiabendazole.

• Use of Ultrafil® Plus for more than 7 days may delay wound healing.
• The use of Ultrafil®Plus may be associated with deafness or partial hearing loss in a small number of sensitive (geriatric) dogs. Hearing loss is usually temporary. If vestibular or hearing dysfunctions are detected during the course of treatment, therapy should be discontinued and flushing of the ear canal should be performed.

Clinical studies and safety studies of ear suspensions formulated with these compounds provide a wide margin of safety according to the recommended dose level. In cases of massive applications, patients may present symptoms associated with overdoses of each of its components, such as:

• Gentamicin: When absorbed systemically it has the potential to cause nephrotoxicosis, neurotoxicosis, and ototoxicosis.
• Betamethasone: Its brief administration, even in massive doses, does not usually cause harmful effects. Its chronic use can cause symptoms of hyperadrenocorticism such as polydipsia, polyuria, weight gain, sodium retention, potassium loss etc.
• Clotrimazole: Signs of overdose caused by Clotrimazole are unlikely to occur as it is poorly absorbed after dermal application.
• Thiabendazole: A modest overdose is unlikely to cause significant problems. In dogs, it has been seen that high and chronic doses can cause signs such as vomiting, diarrhea, alopecia and lethargy.

• Wash your hands after administering the product.
• If the product comes into contact with the eyes, wash with plenty of water.
• In the case of accidental ingestion, do not induce vomiting. Get immediate medical help.

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. For expired or unused products, contact the manufacturing laboratory.

Keep out of reach of children.

Keep at a temperature between 2 and 30°C, away from light. Once opened for the first time, the product lasts for 3 months.

Chile: Sale by prescription to the Veterinary Doctor.
Peru: Over-the-counter.

VETERINARY USE
EXTERNAL USE

Chile: Reg. SAG No. 2210-B
Peru: Reg. SENASA F.83.47.I.0090

Cannula bottle with 20 mL

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