OVARID TABLETS 5MG MEGESTROL ACETATE B.P.

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:

MEGESTROL ACETATE

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

megestrol acetate(5mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

MEGESTROL ACETATE STEROID-PROGESTIN Active 5.0 mg/Tb

Units in package:

200 Tabs

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [EOSINOPHILIC GRANULOMAS, IMPROVING BEHAVIOUR, MILIARY ECZEMA, POSTPONE OESTRUS, PREVENT OESTRUS, URINE SPRAY]; DOG: [IMPROVING BEHAVIOUR, MODIFY HYPERSEXUALITY]; DOG - FEMALE (BITCH): [MAMMARY TUMOURS, POSTPONE OESTRUS, PREVENT OESTRUS, PSEUDO-PREGNANCY]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [EOSINOPHILIC GRANULOMAS, IMPROVING BEHAVIOUR, MILIARY ECZEMA, POSTPONE OESTRUS, PREVENT OESTRUS, URINE SPRAY]; DOG: [IMPROVING BEHAVIOUR, MODIFY HYPERSEXUALITY]; DOG - FEMALE (BITCH): [MAMMARY TUMOURS, POSTPONE OESTRUS, PREVENT OESTRUS, PSEUDO-PREGNANCY]; For postponement or prevention of oestrus & treatment of false pregnancy and oestrogen-dependent mammary tumors in bitches. For oestrus control and treatment of miliary eczema and oesinophilic granuloma in cats. For the treatment of behavioural abnormalitNot recommended in diabetic animals. See DIRECTIONS FOR USE on leaflet also.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

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INFOPEST – COMPANY SUPPLIED LABEL
OVARID 5MG
CARTON FRONT & REAR
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
OVARID® TABLETS 5 MG
MEGESTROL ACETATE B.P.
For the postponement or prevention of oestrus and the
treatment of false pregnancy and oestrogen-dependent
mammary tumours in bitches. For oestrus control and for the
treatment of miliary eczema and oesinophilic granuloma
(rodent ulcer) in cats. For the treatment of behavioural
abnormalities, such as hypersexuality in male dogs and urine
spraying in cats.
200 TABLETS
JUROX
____________________________________________________________________________________________________
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OVARID 5MG
CARTON SIDE (1)
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
Made in Australia by
JUROX LOGO
Jurox Pty. Ltd.
Unit 22, Slough Estate, Holker St.,
Silverwater, NSW, 2128, Australia
Under licence from:
Schering-Plough Animal Health
® Schering-Plough Animal Health Limited Registered Trade Mark
____________________________________________________________________________________________________
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OVARID 5MG
CARTON SIDE (2)
DISPOSE of container by wrapping in paper and putting in garbage.
STORE below 30
o
C (Room Temperature) in a dry place.
B
EXP.
NRA 36149/1298
____________________________________________________________________________________________________
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OVARID 5MG
CARTON FLAPS (BOTTOM AND TOP)
OVARID® TABLETS 5 MG
200 TABLETS
____________________________________________________________________________________________________
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OVARID 5MG
FOIL
FOR ANIMAL TREATMENT ONLY
OVARID®
5 MG MEGESTROL ACETATE
JUROX
[B]
[E]
NRA 36149/1298
____________________________________________________________________________________

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Summary of Product characteristics

MATERIAL SAFETY DATA SHEET
PRODUCT NAME: OVARID TABLETS
Issue Date: 01FEB08
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 Gardiner Road, Rutherford NSW 2320
Telephone:
(02) 4931 8200 or 1800 023 312
Emergency Telephone No.:
(02) 4931 8200 or 1800 023 312
IDENTIFICATION
Product Name:
Ovarid Tablets
Other Names:
Manufacturer’s Product Code:
60910 (5mg tablets), 60900 (20mg tablets)
UN Number:
None Allocated
Dangerous Goods Class:
None Allocated
Subsidiary Risk:
None Allocated
Hazchem Code:
None Allocated
Poisons Schedule Number:
4
Use:
Tablets for the prevention or postponement of oestrus in dogs
and cats, treatment of miliary eczema and rodent ulcer in
cats, oestrogen-dependent mammary tumours in bitches and
behavioural abnormalities in dogs and cats.
PHYSICAL PROPERTIES / DESCRIPTION
Appearance:
Buff-coloured, slightly speckled uncoated biconvex tablet,
half-scored on one side.
Boiling Point/Melting Point:
Vapour Pressure:
Specific Gravity:
Flashpoint:
Non-flammable
Flammability Limits:
Solubility in Water:
Partly soluble (disintegrate)
Table Weight:
~300mg (5mg tablets), ~450mg (20mg tablets)
OTHER PROPERTIES
INGREDIENTS
CHEMICAL ENTITY
CAS NUMBER
PROPORTION
Megestrol Acetate
595-33-5
1.7% (5mg tablet)
4.4% (20mg tablet)
Dried Yeast
to 100%
MATERIAL SAFETY DATA SHEET
PRODUCT NAME: OVARID TABLETS
Issue Date: 01FEB08
QAF140
Page 2 of 3
HEALTH & HAZARD INFORMATION
HEALTH EFFECTS
ACUTE
Swallowed:
May cause nausea, vomiting and diarrhoea. Readily absorbed from
the gastro-intestinal tract. May lead to oedema, headache and
depression.
Eye:
Non-irritant due to the nature of the product.
Skin:
Non-irritant
Inhaled:
Does not present an inhalation problem.
CHRONIC
Due to the presence of Megestrol Acetate, prolonged or repeated
exposure may lead to weight
gain, acne, oedema, gastro-intestinal side effects, depression and
alteration in liver function.
FIRST AID
If poisoning occurs, contact a docto

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