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Registered Product Name: OTOMAX Ointment Page 1 of 6 Pack Sizes: 7.5g [15g, 14 mL, 34 mL, 240 mL, 12 x 7.5g, 12 x 15g, 12 x 14mL, 6 x 34 mL] Date (Version Control): 26/09/2013 APVMA: 51104/58945 Description: Primary Carton Panel labels, text above the header and below the footer are not included in this label text. PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN READ SAFETY DIRECTIONS BEFORE OPENING OR USING FOR ANIMAL TREATMENT ONLY OTOMAX® Ointment RLP Approved ACTIVE INGREDIENTS: GENTAMICIN SULFATE equivalent to 2640 IU Gentam icin Base, 1.07mg BETAMETHASONE VALERATE equivalent to 0.88 mg Betamethasone and 8.80 mg CLOTRIMAZOLE per ml. For the treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin. 7.5g [1 5g,14 mL, 34 mL, 240 mL, 12 x 7.5g , 12 x 15g, 12 x 14mL, 6 x 34 mL] MSD logo READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT DIRECTIONS FOR USE: Restraint NOT FOR USE in food-producing animals. Contraindications Contraindicated for use in animals with known perforation of the eardrum (tympanic membrane). Contraindicated for use in pregnant or lactating animals. Contraindicated for concomitant use with drugs known to induce ototoxicity. Precautions If hyper-sensitivity to any component occurs, discontinue treatment and institute appropriate therapy. Avoid concomitant use of drugs known to induce ototoxicity. Administration of recommended doses beyond 7 days may result in delayed wound healing. Prolonged use or overdosage may produce adverse immunosuppressive effects. Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to use of this preparation. Dosage and Administration SHAKE WELL BEFORE USE. Thoroughly clean and dry external ear. Rem ove foreign material, crusted and dried debris etc. with a non-irritating solution. Clip excessive hair from treatment area. Examine ear canal to ensure tympanic membrane is not ruptured. Dogs less than 15kg: 4 drops. Dogs 15kg or more: 8 drops. Instil twice daily into ear canal. Therapy should continue for 7 consecutive days. For further information contact MSD Animal Health Customer Service on 1 800 033 461 or New Zealand Customer Service on 0800 BOO 543. SAFETY DIRECTIONS Will irritate the eyes. Avoid contact with eyes. If product in eyes, wash out immediately with water. Wash hands after use. -------------------------------- Pagel ' Registered Product Name: OTOMAX Oinlmenl Pack Sizes: 7.5g [15g, 14 mL, 34 mL, 240 mL, 12 x 7.5g, 12 x 15g, 12 X 14mL, 6 X 34 mL] Page 2 of 6 Description: Primary Carton APVMA: 51104/58945 Date (Version Control): 26/09/2013 Panel labels, text above the header and belm,., the footer are not included in this label text. FIRST AID If poisoning occurs, contact a doctor or Poisons Information Centre (Phone Australia 131126) or New Zealand National Poisons Centre (Phone 0800 POISON- 0800 764 766). Dispose of empty container by wrapping with paper and putting in garbage. Unused product should be returned to a veterinarian. Store below 25'C (Air Conditioning). See top panel for Batch and Expiry APVMA Approval No.: 511 04/58945 MSD Animal Health lntervet Australia Ply Ltd 91-105 Harpin St Bendigo East Vic 3550 Ph: Customer Service 1800 033 461 New Zealand Information RESTRICTED VETERINARY MEDICINE ACVM No: A7883. Registered to: Schering-Piough Animal Health Ltd Phone: 0800 800 543 www.msd-animal-health.co.nz ----------------------------- Page2 Registered Product Name: OTOMAX Ointment Pack Sizes: 7.5g [15g,14 ml, 34 ml, 240 ml, 12 x 7.5g, 12 x 15g, 12 x 14ml, 6 x 34 ml] Description: Leaflet . Page 3 of6 Date (Version Control): 2610912013 APVMA: 51104/58945 Panel labels, text above the header and below the footer are not included in this label text. PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN READ SAFETY DIRECTIONS BEFORE OPENING OR USING FOR ANIMAL TREATMENT ONLY OTOMAX® Ointment ACTIVE INGREDIENTS: GENTAMICIN SULFATE equivalent to 2640 IU Gentamicin Base, 1.07mg BETAMETHASONE VALERATE equivalent to 0.88 mg Betamethasone and 8.80 mg CLOTRIMAZOLE per ml. Indications: For the treatment of canine acute and chronic otitis extema associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin. Pharmacology: Gentamicin sulfate is an aminoglycoside antibiotic active against a wide variety of pathogenic gramnegative and gram-positive bacteria. In vitro tests have determined that gentamicin is bactericidal and acts by inhibiting normal protein synthesis in susceptible microorganisms. Specifically, gentamicin is active against the following organisms commonly isolated from canine ears: Staphylococcus intermedius, other coagulase-positive Staphylococcus spp., Pseudomonas aeruginosa, Proteus spp., and Escherichia coli. Betamethasone valerate is a synthetic adrenocorticoid for dermatologic use. Betamethasone, an analogue of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticosteroid activity. Betamethasone valerate, the 17-valerate ester of betamethasone, has been shown to provide anti-inflammatory and anti-pruritic activity in the topical management of corticosteroid-responsive otitis externa. Topical corticosteroids can be absorbed from normal, intact skin. Inflammation can increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes and yeasts. The primary action of clotrimazole is against dividing and growing organisms. In vitro, clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis, Candida spp., and Malassezia pachydermatis (Pityrosporum canis). Resistance to clotrimazole is very rare among the fungi that cause superficial mycoses. In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. These events began rapidly and extensively after addition of the drug. Clotrimazole is very poorly absorbed following dermal application. Restraint NOT FOR USE in food-producing animals. Contraindications Contraindicated for use in animals with known perforation of the eardrum (tympanic membrane). Contraindicated for use in pregnant or lactating animals. Contraindicated for concomitant use with drugs known to induce ototoxicity. ----------------------------- Page3 Registered Product Name: OTOMAX Ointment Pack Sizes: 7.5g [15g ,14 ml, 34 m L, 240 ml, 12 x 7.5g, 12 x 15g, 12 x 14ml, 6 x 34 ml] Page 4 of6 Date (Version Control): 26/09/2013 Description: Leaflet APVMA: 51104/58945 Panel labels, text above the header and below the footer are not included in this label text. Precautions If hypersensitivity to any component occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Corticosteroids administered to dogs, rabbits and rodents during pregnancy have resulted in cleft palate offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, foetal death, retained placenta and metritis. Administration of recommended doses of OTOMAX beyond 7 days may result in delayed wound healing . Adverse systemic reactions have been observed following the oral ingestion of some topical corticosteroid preparations. Patients should be closely observed for the usual signs of adrenocorticoid overdosage which include sodium retention, potassium loss, fluid retention, weight gain, polydipsia, and/or polyuria. Prolonged use or overdosage may produce adverse immunosuppressive effects. Special Precautions for Use: Identification of infecting organisms should be made either by microscopic roll smear evaluation or by culture as appropriate. If overgrowth of nonsusceptible bacteria, fungi or yeasts occur, or if hypersensitivity develops , treatment should be discontinued and appropriate therapy instituted. Antibiotic susceptibility of the pathogenic organism(s) should be determin ed prior to use of this preparation. The use of OTOMAX® has been associated with deafness or partial hearing loss in a small number of sensitive dogs (eg. geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of OTOMAX® immediately and flush the ear canal thoroughly with a non-ototoxic solution. Undesirable Effects: Gentamicin: While aminoglycosides are absorbed poorly from skin, intoxication may occur when aminoglycosides are applied topically for prolonged periods of time to large wounds, burns or any denuded skin, particularly if there is renal insufficiency. All aminoglycosides have the potential to produce reversible and irreversible vestibular, cochlear and renal toxicity. Betamethasone: Side effects such as SAP and SGPT enzyme elevations, weight loss, anorexia, polydypsia and polyuria have occurred following the use of parenteral or systemic synthetic corticosteroids in dogs. Vomiting and diarrhoea (occasionally bloody) have been observed in dogs. Use of corticosteroids, depending on dose and duration may result in endogenous steroid production inhibition following drug withdrawal. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy. Clotrimazole: The following have been reported occasionally in humans in connection with the use of clotrimazole: erythema, stinging , blistering , peeling, oedema, pruritus, urticaria and general irritation of the skin not present before therapy. Dosage and Administration: SHAKE WELL BEFORE USE The external ear should be thoroughly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates etc. with suitable non-irritating solutions. Excessive hair should be clipped from the treatment area. Page4 Registered Product Name: OTOMAX Ointment Pack Sizes: 7.5g [15g, 14 ml, 34 ml, 240 ml, 12 x 7.5g, 12 x 15g, 12 x 14ml, 6 x 34 ml] Page 5 of 6 Date (Version Control): 26/09/2013 APV:\olA: 51104/58945 Panel labels, text above the header and belo\y the footer are not included in this label text. Description; Leaflet Before instilling any medication into the ear, examine the external ear canal thoroughly to be certain the tympanic membrane is not ruptured in order to avoid the possibility of transmitting infection to the middle ear as well as damaging the cochlea or vestibular apparatus from prolonged contact. After verifying that the eardrum is intact, shake well and instill 4 drops twice daily into the ear canal of dogs weighing less than 15kg. Instill 8 drops twice daily into the ear canal of dogs weighing 15kg or more. Therapy should continue for 7 consecutive days. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of OTOMAX®, For further information contact MSD Animal Health Customer Service on 1 800 033 461 or New Zealand Customer Service on 0800 800 543. FIRST AID If poisoning occurs, contact a doctor or Poisons Information Centre (Phone Australia 131126) or New Zealand National Poisons Centre (Phone 0800 POISON- 0800 764 766). SAFETY DIRECTIONS Will irritate the eyes. Avoid contact with eyes. If product in eyes, wash out immediately with water. Wash hands after use. DISPOSAL Dispose of empty container by wrapping with paper and putting in garbage. Unused product should be returned to a veterinarian. STORAGE Store below 25°C (Air Conditioning). WARRANTY lntervet Australia Pty Ltd (IAPL), also known as MSD Animal Health, warrants that this product is of merchantable quality and fit for its intended purpose. IAPL's liability for any loss, including consequential losses or injury caused by act or omission, including negligent acts or omissions, by IAPL or its agent, is limited to replacing or repairing the product at the option of IAPL. If possible, a sample of any product causing concern should be retained or delivered to IAPL within 30 days for a scientific examination. APVMAApproval No.: 51104/58945 New Zealand Information MSD Animal Health lntervet Australia Pty Ltd 91-105 Harpin St Bendigo East Vic 3550 Ph: Customer Service 1800 033 461 RESTRICTED VETERINARY MEDICINE ACVM No: A7883. Registered to: Schering-Piough Animal Health Ltd Phone: 0800 800 543 www.msd-animal-health.co.nz ® Registered Trademark --~-------------------------PageS Registered Product Name: OTOMAX Ointment Pack Sizes: 7.5g [15g, 14 mL, 34 mL, 240 mL, 12 x 7.5g, 12 x 15g, 12 x 14mL, 6 X 34 ml] Page 6 of6 Date (Version Control): 26/09/2013 APVMA: 51104/58945 Description: Immediate Container Label Panel labels, text above the header and below the footer are not included in this label text. PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN READ SAFETY DIRECTIONS BEFORE OPENING OR USING FOR ANIMAL TREATMENT ONLY OTOMAX® Ointment ACTIVE INGREDIENTS: GENTAMICIN SULFATE equivalent to 2640 IU Gentamicin Base, 1.07mg BETAMETHASONE VALERATE equivalent to 0.88 mg Betamethasone and 8.80 mg CLOTRIMAZOLE per ml. 7.5g [15g,14 mL, 34 ml, 240 ml] [MSD Animal Health logo] For the treatment of canine acute and chronic otitis externa associated with yeast (Ma/assezia pachydermatis) and/or bacteria susceptible to gentamicin. READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT Dispose of empty container by wrapping with paper and putting in garbage. Unused product should be returned to a veterinarian. Store below 25'C (Air Conditioning). APVMA No.: 51104158945 MSD Animal Health lntervet Australia Ply Ltd 91-105 Harpin St Bendigo East Vic 3550 Ph: Customer Service 1800 033 461 NZ Information I RVM ACVM No: A7883. (B) EXP. ------------------------------- Page6