VR DEPREDONE INJECTION OF LONG ACTING PREDNISOLONE FOR DOGS, CATS AND HORSES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

19-06-2017

Active ingredient:

METHYLPREDNISOLONE ACETATE

Available from:

AUSRICHTER PTY LTD

INN (International Name):

methylprednisolone as acetate(34.6mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

METHYLPREDNISOLONE ACETATE STEROID-GLUCOCORTICOID Active 40.0 mg/ml

Units in package:

10mL

Class:

VM - Veterinary Medicine

Manufactured by:

AUSRICHTER

Therapeutic group:

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: MEAT: Do not administer to horses less than 60 days before slaughter for human consumption.; Host/pest details: CAT: [ANTI-INFLAMMATORY AGENT, ARTHRITIS, DERMATITIS, EOSINOPHILIC GRANULOMAS, MUSCULOSKELETAL CONDITIONS, OCULAR CONDITION, PRURITIS]; DOG: [ANTI-INFLAMMATORY AGENT, ARTHRITIS, DERMATITIS, MUSCULOSKELETAL CONDITIONS, OCULAR CONDITION, PRURITIS]; HORSE: [ANTI-INFLAMMATORY AGENT, ARTHRITIS, DERMATITIS, MUSCULOSKELETAL CONDITIONS, OCULAR CONDITION, PRURITIS]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ANTI-INFLAMMATORY AGENT, ARTHRITIS, DERMATITIS, EOSINOPHILIC GRANULOMAS, MUSCULOSKELETAL CONDITIONS, OCULAR CONDITION, PRURITIS]; DOG: [ANTI-INFLAMMATORY AGENT, ARTHRITIS, DERMATITIS, MUSCULOSKELETAL CONDITIONS, OCULAR CONDITION, PRURITIS]; HORSE: [ANTI-INFLAMMATORY AGENT, ARTHRITIS, DERMATITIS, MUSCULOSKELETAL CONDITIONS, OCULAR CONDITION, PRURITIS]; Suppression of inflammation, arthritic conditions, relief of pruritis and inflammation in dermatitis in dogs, cats and horses. Allergic conditions in dogs and cats, Pain and lameness associated with musculoskeletal conditions, and ocular conditions.Do not use in ulcerative conditions of the cornea (until a negative fluorescein stain has been obtained) or in animals with Cushing’s Disease. See also PRECAUTIONS/ADVERSE REACTIONS on leaflet.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
BBU
DEPREDONE@
INJECTION OF LONG-ACTING
PREONISOLONE
FOR DOGS,
CIWS AND HORSES
COMPOSITION: Methylpredmsolone acetate 40
mg/mL
(equrvalent to 34.6
mg/mL
methylprednisolone); benzyl alcohol 1
ml-/100
mL as preservative.
ACTIONS:
Prolonged
action
synthetic
anti-mflammatoj
sterord
wrth
mmlmal
mrneralocortrcord activity. In this depot form, the sterord
IS
slowly released and has
a therapeutic duration of 2 to 3 weeks.
INDICATIONS: Suppression of mflammatron. arthritic condihons: relief
of pruritisand
mflammation
in dermatitis in dogs, cats and horses.
A//erg/c conditions in dogs and
_cats _ Pruritis
associated
with
contact
allergens
Systemic allergic conditions are more effective!y treated with an
intravenous steroid
such as dexamethasone.
_Musculoskeletal_
_ conditions. _ Pain and lameness associated with local or systemic
nonseptic arthrrtrc conditions; also of benefit
rn
the management of acuteand chrome
synovitrs,
tendomtis,
bursrtrs, myositis and periostitis. The drug may be administered
topically (into the lesion) or systemically.
_Ocular _
_conditions. _
Management
of
inflammatory
eye
conditions.
Subconjunctival
administration of the drug results
rn
a high concentration of the drug and a prolonged
duration of therapy
in
the eye, thus avoiding the frequent administration of steroids
that are required wrth other therapeutic preparations
_‘fosmophlc_
_ _
_gfanulomas_
_ _
_m_
cats.'
These
have also been successfully treated by the
systemic use of Depredone However, a more beneficial regimen has been
observed
by the intralesronal injection of triamcinolone acetonide.
PRECAUTIONS: Corticosterords tend to decrease chemotachc properties of
phagocytes
and thus tend to decrease the efficacy of host defence mechanisms They
may also
tend to modrfy the natural antibody defence mechanisms.
Use with caution where severe tissue damage is present It is
recommended that
rn
such cases and where an infective process
IS
suspected, antibiotic thera

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Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: DEPREDONE INJECTION
Issue Date: 29JAN08
QAF140
Page 1 of 3
STATEMENT OF HAZARDOUS NATURE
NOT CLASSIFIED AS HAZARDOUS ACCORDING TO CRITERIA OF NOHSC AUSTRALIA
COMPANY DETAILS
Company:
Jurox Pty Limited,
Address:
85 Gardiners Road, Rutherford NSW 2320
Telephone:
(02) 4931 8200 or 1800 023 312
Emergency Telephone No.:
(02) 4931 8200 or 1800 023 312
Company:
Jurox New Zealand Limited
Address:
8 Kordel Place, East Tamaki, Auckland
Telephone:
0800 587 696
Emergency Telephone No:
0800 587 696
IDENTIFICATION
Product Name:
Depredone Injection
Other Names:
Manufacturer’s Product Code:
60840
UN Number:
None Allocated
Dangerous Goods Class:
None Allocated
Subsidiary Risk:
None Allocated
Hazchem Code:
None Allocated
Poisons Schedule Number:
S4 (Aus), PAR1 (NZ)
Use:
Sterile corticosteroid injection for the suppression of
inflammation, arthritic conditions, relief of pruritis and
inflammation in dermatitis for horses, dogs and cats.
PHYSICAL PROPERTIES / DESCRIPTION
Appearance:
White suspension in clear colourless liquid
Boiling Point/Melting Point:
Vapour Pressure:
Specific Gravity:
Flashpoint:
Non-flammable
Flammability Limits:
Solubility in Water:
Miscible
pH:
5.0 – 7.0
OTHER PROPERTIES
INGREDIENTS
CHEMICAL ENTITY
CAS NUMBER
PROPORTION
6-A-Methyl Prednisolone Acetate
52-21-1
4%
Water
7732-18-5
to 100%
MATERIAL SAFETY DATA SHEET
PRODUCT NAME: DEPREDONE INJECTION
Issue Date: 29JAN08
QAF140
Page 2 of 3
HEALTH HAZARD INFORMATION
HEALTH EFFECTS
ACUTE
Swallowed:
May result in dizziness, nausea and vomiting. Absorbed through
the oral mucosa and gastrointestinal tract.
Eye:
Moderate irritant
Skin:
Mild irritant. Absorbed through the skin.
Inhaled:
Does not present an inhalation problem
Injected:
Effects will vary in severity according to the quantity involved, from
localized site reaction (swelling, pain, redness), to acute systemic
reaction.
CHRONIC
Due to the presence of 6-A-Methyl Prednisoloe Acetate, prolonged or
repeated contact may lead to
electrolyte imbalance, oedema, hypertension

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