Rostrum® Plus

Ear emulsion.

Otic, antibacterial and antifungal emulsion.

Each mL of emulsion contains:
Enrofloxacin……………………. 5 mg
Silver Sulfadiazine………… 10 mg
Excipients c.s.p……………….. 1 mL

Indicated for the treatment of acute or chronic otitis externa in dogs caused by bacteria and fungi sensitive to enrofloxacin and/or silver sulfadiazine. Its use is indicated for otic infections associated with one or more of the following organisms: Malassezia pachydermatis, coagulase-positive Staphylococcus spp., Pseudomonas aeruginosa, Enterobacter spp., Proteus mirabilis, Streptococcus spp., Aeromonas hydrophila, Aspergillus spp., Klebsiella pneumoniae, and Candida albicans.

Apply 5 to 10 drops (equivalent to 0.2 to 0.4 mL) per affected ear in dogs weighing 15 Kg or more; and 10 to 15 drops (equivalent to 0.4 to 0.6 mL) per affected ear in dogs weighing more than 15 Kg.

Clean the ear canal; shake before use. Administer Rostrum® Plus according to the indicated dose, gently massaging the ear to ensure complete and even distribution of the medication throughout the canal.

Dogs.

• Do not use in dogs with known hypersensitivity to quinolones and/or sulfonamides.
• Do not use in dogs with a perforated tympanic membrane.
• Do not administer to pregnant or lactating females.

• Keep out of reach of children and pets.
• The use of this combination has not been evaluated in dogs with perforated tympanic membranes.
  Therefore, before administering the product, the external auditory canal should be examined to ensure there is no rupture of the tympanic membrane, in order to avoid contamination of the middle ear, as well as vestibular and cochlear injuries. If signs of deafness or vestibular disturbances appear during administration of the product, discontinue use.
• Quinolones should be used with caution in animals with central nervous system (CNS) disorders. In these animals, in rare cases, quinolones have been associated with CNS stimulation, which can cause seizures.
• Fluoroquinolones, such as enrofloxacin, should not be used as first-line treatment, unless there is no alternative therapy available. When used as a secondary treatment, it should be based on susceptibility studies.

• With the exception of possible cartilage abnormalities in young animals, the adverse effect profile of enrofloxacin is generally limited to gastrointestinal problems (vomiting, anorexia), although rare incidents of elevated liver enzymes, ataxia, seizures, depression, and lethargy have also been reported.
• No evidence of systemic toxicity from silver sulfadiazine has been reported in dogs; even 1% silver sulfadiazine otic suspensions have been used in dogs for more than three months without incident.

Do not use concomitantly with other pharmaceutical products.

• Do not handle by people who are hypersensitive to the active ingredients.
• Wash your hands immediately after administering the product.
• In case of contact with skin, eyes, or mucous membranes, rinse immediately with plenty of water. In case of irritation, seek medical attention and show the product information leaflet.
• In case of accidental ingestion, seek medical attention immediately and show the product information leaflet.

Store at room temperature below 25 °C. Do not refrigerate or freeze. Once opened, use within 4 weeks. Discard unused product after this period.

For export: Store in a cool, dry place at room temperature between 15 and 30 °C, protected from light.

Empty containers can be disposed of as household waste without any special precautions. Do not dispose of containers with product residue on the ground or in waterways. For expired or unused products, contact the manufacturer.

• For Chile: Sale under prescription Retained Veterinary Doctor.
• For Export: Sale under prescription Veterinary Doctor.

VETERINARY USE
SHAKE BEFORE USE

Chile: Reg. SAG N° 1523
Bolivia: Reg. SENASAG PUV-F-N° 006147/14
El Salvador: VE2014084963
Perú: Reg. SENASA F.82.73.I.0022

Container with 15 mL

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

Laboratorio Drag Pharma Chile Invetec S.A.