FELIMAZOLE 2.5 MG COATED TABLET

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

THIAMAZOLE

Available from:

DECHRA LTD

INN (International Name):

thiamazole(2.5mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

THIAMAZOLE UNGROUPED Active 2.5 mg/Tb

Units in package:

100 tablets (4 Blister packs with 25 tablets in a carton)

Class:

VM - Veterinary Medicine

Manufactured by:

DERMCARE-VET

Therapeutic group:

CAT | CAT - QUEEN | CAT - TOM | KITTEN

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

HYPERTHYROIDISM | FELINE

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [HYPERTHYROIDISM]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [HYPERTHYROIDISM]; For the stabilisation of feline hyperthyroidism as a pre-operative therapy. For the long-term treatment of feline hyperthyroidism.See CONTRAINDICATIONS, PRECAUTIONS and WARNING statements on label

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

FELIMAZOLE 2.5 MG COATED TABLET
63927/120328
Product Name:
APVMA Approval No:
Label Name:
FELIMAZOLE 2.5 MG COATED TABLET
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ SAFETY DIRECTIONS BEFORE OPENING OR USING
Constituent
Statements:
2.5 mg/Tb THIAMAZOLE (Methimazole)
Claims:
Thiamazole is indicated for both the stabilization of feline
hyperthyroidism prior to surgical
thyroidectomy and for the long-term treatment of feline
hyperthyroidism.
Net Contents:
100 Tablets
Directions for Use:
Restraints:
Contraindications:
Contraindicated for use in pregnant or lactating queens.
Contraindicated for use in cats suffering from systemic disease, such
as primary liver
disease or diabetes mellitus.
Contraindicated for use in cats showing signs of autoimmune disease.
Contraindicated for use in animals with disorders of white blood
cells, such as neutropaenia
and lymphopaenia.
Contraindicated for use in animals with platelet disorders and
coagulopathies (particularly
thrombocytopaenia).
Contraindicated for use in cats with hypersensitivity to thiamazole or
the excipient,
polyethylene glycol. RLP APPROVED
Precautions:
Concurrent treatment with phenobarbital may reduce the clinical
efficacy of thiamazole.
Concurrent treatment with benzimidazole wormers is known to reduce the
hepatic oxidation
of these actives and may lead to increases in circulating levels.
Thiamazole is immunomodulatory therefore this should be taken into
account when
considering vaccination programmes.
Side Effects:
Side effects vary depending on dose regime and duration of treatment.
In a clinical field
study, approximately 20% of the cats experienced some form of adverse
reaction, most
frequently when the product was used for long-term treatment of
hyperthyroidism. In
many cases, clinical signs were mild and transitory, and not a reason
for withdrawal
of treatment. The more serious effects were usually reversible when
medication was
stopped. At doses of up to 15 mg, clinical side effects included:
vo

Safety Data Sheet

Product:
................
FELIMAZOLE 2.5 MG - AUS - CARTON
Dimensions:...............................................45 mm x 45
mm x 67 mm
Primary brand name font size:
............................................... 16.22pt
Primary brand description font
size:....................................... 13.78pt
Body text font size: .................................... 7pt & 6.3pt
on back panel
Item code:
...............................................................................G1560
Pharmacode:
...............................................................................
N/A
Regulatory
..................................................
Marketing
...................................................
Technical
....................................................
Date
...........................
Date
...........................
Date
...........................
Date:
Proof:
1 (CC)
2 (CC)
3 (NH)
10-02-2015
11-02-2015
24-02-2015
Date:
Proof:
Pantone reference guide
Colours to be printed:
Do not print
541
541 - 50%
541 - 30%
541 - 20%
223
123
VARNISH FREE
CUTTER GUIDE
STYLE DEVIATIONS
CC
Disposal: Dispose of empty container by
wrapping with paper and putting in garbage.
Unused product should be returned to the
veterinary surgeon.
Storage instructions: Store below 25°C
(Air Conditioning) in a dry place.
Keep container closed and protect from light.
ACTIVE CONSTITUENT:
Each tablet contains 2.5 mg
Thiamazole (Methimazole)
For the stabilisation of feline
hyperthyroidism as a pre-operative
therapy
For the long-term treatment
of feline hyperthyroidism
100 tablets
DIRECTIONS FOR USE:
READ THE ENCLOSED LEAFLET BEFORE
USING THIS PRODUCT.
For oral administration only.
SAFETY DIRECTIONS:
Wash hands after use.
Do not break or crush tablets.
Warning Statements and General Safety
Precautions: Thiamazole may cause birth
defects. Women of child bearing age are
advised not to administer this product. Children
and pregnant women should not come into
contact with this drug. Keep children and
pregnant women away from vomitus, faeces
and