ATOPICA 100 MG/ML ORAL SOLUTION FOR CATS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

CYCLOSPORIN

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

cyclosporin(100mg/mL)

Pharmaceutical form:

ORAL SOLUTION/SUSPENSION

Composition:

CYCLOSPORIN BIOLOGICAL-ORGANISM-FUNGUS Active 100.0 mg/ml

Units in package:

17mL; 5mL

Class:

VM - Veterinary Medicine

Manufactured by:

ELANCO AUSTRALASIA

Therapeutic group:

CAT | CAT - QUEEN | CAT - TOM | KITTEN

Therapeutic area:

MISCELLANEOUS VETERINARY

Therapeutic indications:

ALLERGIC DERMATITIS | ATOPY

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ALLERGIC DERMATITIS]; For the treatment of allergic dermatitis in cats.For animal treatment only. Not for use in cats infected with FeLV or FIV. Not for cats with history of malignant disorders or progressive malignant disorders. See DIRECTIONS FOR USE etc on label.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

ATOPICA 100 MG/ML ORAL SOLUTION FOR CATS
66305/123263
Product Name:
APVMA Approval No:
Label Name:
ATOPICA 100 MG/ML ORAL SOLUTION FOR CATS
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
100 mg/ml CYCLOSPORIN
Claims:
For the treatment of allergic dermatitis in cats
Net Contents:
17mL
5mL
Directions for Use:
Restraints:
Contraindications:
This product is contraindicated for use in cats infected with FeLV or
FIV.
This product is contraindicated for use in cats with a history of
malignant disorders or
progressive malignant disorders.
The efficacy and safety of cyclosporin has not been assessed in cats
aged less than 6
months or weighing less than 2.3 kg. This product is contraindicated
for use in cats aged
less than 6 months or weighing less than 2.3 kg.
The safety of the drug has not been studied in male reproducing cats
or in pregnant or
lactating female cats. Cyclosporin was teratogenic in laboratory
animals at maternally toxic
doses, however, no teratogenic effects were observed in the
well-tolerated dose range.
In laboratory animals, cyclosporin crosses the placenta barrier and is
excreted via milk. A
thorough risk/benefit analysis should be undertaken before using in
reproducing, pregnant
or lactating cats.
Precautions:
Cyclosporin may cause elevated levels of blood glucose. The effect of
cyclosporin in cats
with diabetes has not been evaluated. Cyclosporin should be used with
caution in cats with
diabetes mellitus. RLP APPROVED
While cyclosporin does not induce tumours, it does inhibit
T-lymphocytes and therefore
treatment with cyclosporin may lead to an increased incidence of
clinically apparent
malignancy. If lymphadenopathy is observed in cats being treated with
cyclosporin, further
clinical investigations are recommended and treatment discontinued if
necessary.
Cats that are seronegative for T. gondii may be at risk of developing
clinical toxoplasmosis
if they become infected while under treatment. In rare cases this can
be fatal

Summary of Product characteristics

Issue date: 11-November-2016
Supersedes date: 06-September-2017
Revision date: 04-March-2019
Version number: 06
SAFETY DATA SHEET
1. Identification
ATOPICA 100 MG/ML ORAL SOLUTION FOR CATS
Product identifier
Other means of identification
ATOPICA Dog Solution * A-12211 A * ATOPLUS 100 MG/ML SOL * ATOPICA 100
MG/ML SOL *
ATOPICA CAT Solution * NEORAL 100 MG/ML SOL
Synonyms
CA4900
Item Code
Recommended use of the chemical and restrictions on use
Veterinary Product
Recommended use
Not available.
Restrictions on use
Details of manufacturer or importer
Elanco Australasia Pty Ltd.
Company name
ACN: 076 745 198
112 Wharf Road
Address
West Ryde, NSW 2114
Australia
1800 995 709 (toll free)
Telephone
[e-mail]
E-mail
Elanco Australasia 1800 995 709 (toll free)
Emergency phone number
CHEMWATCH 1800 039 008 (spills and accidents)
24 hr emergency contact
number
CHEMWATCH [phone] (spills and accidents)
24 hr emergency contact
number (Local)
2. Hazard(s) identification
Classification of the hazardous chemical
Category 3
Flammable liquids
Physical hazards
Category 1A
Carcinogenicity
Health hazards
Category 2
Reproductive toxicity
Category 1
Specific target organ toxicity following
repeated exposure
Not classified.
Environmental hazards
Label elements, including precautionary statements
Hazard symbol(s)
Health
hazard
Flame
Signal word
Danger
Hazard statement(s)
Flammable liquid and vapour. May cause cancer. Causes damage to organs
(Immune System,
Kidney) through prolonged or repeated exposure. Suspected of damaging
the unborn child.
1 / 9
Material name: ATOPICA 100 MG/ML ORAL SOLUTION FOR CATS
6167
SDS AUSTRALIA
Precautionary statement(s)
Prevention
Obtain special instructions before use. Do not handle until all safety
precautions have been read
and understood. Keep away from heat, hot surfaces, sparks, open flames
and other ignition
sources. No smoking. Wear protective gloves/protective clothing/eye
protection/face protection.
Do not breathe mist/vapours.
Response
IF exposed or concerned: Get medical advice/at