Download OTOMAX® Ointment

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.
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