Atopica 100 mg/mL Oral Solution for Cats

Country: New Zealand

Language: English

Source: Ministry for Primary Industries

Active ingredient:

cyclosporin a.

Available from:

Elanco Australasia Pty Ltd

INN (International Name):

cyclosporin a.

Composition:

cyclosporin a. 100 g/litre

Therapeutic area:

Immunomodulator

Authorization status:

ACVM Registered

Authorization date:

2013-02-19

Summary of Product characteristics

COMPANY CONFIDENTIAL
PRODUCT NAME: Atopica 100 mg/mL Oral Solutions for Cats
REVISION DATE: 24 JUL 2023
PAGE: 1 of 10
PACK SIZES: 5 or 17 mL
TYPE OF LABEL: Carton, Bottle, Leaflet
PREPARED BY: T Le
COUNTRY: New Zealand
REASON: Update manufacturer
Text above this line is not included in the actual label.
GENERIC PRODUCT NAME:
VERSION:
REVISION DATE
APVMA/ACVMCODE
Atopica 100 mg/mL Oral Solution for Cats
FINAL
24 Jul 2023
A010698
COPYRIGHT © 2023 ELANCO OR ITS AFFILIATES
_CARTON – FRONT PANEL _
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
ATOPICA
™
100 MG/ML ORAL SOLUTION FOR CATS
ACTIVE CONSTITUENT: EACH ML CONTAINS 100 MG CYCLOSPORIN
Indication: For the treatment of allergic dermatitis in cats
[graphic of cat]
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
5 ML OR 17 ML
Elanco logo
15/08/2023
COMPANY CONFIDENTIAL
PRODUCT NAME: Atopica 100 mg/mL Oral Solutions for Cats
REVISION DATE: 24 JUL 2023
PAGE: 2 of 10
PACK SIZES: 5 or 17 mL
TYPE OF LABEL: Carton, Bottle, Leaflet
PREPARED BY: T Le
COUNTRY: New Zealand
REASON: Update manufacturer
Text above this line is not included in the actual label.
GENERIC PRODUCT NAME:
VERSION:
REVISION DATE
APVMA/ACVMCODE
Atopica 100 mg/mL Oral Solution for Cats
FINAL
24 Jul 2023
A010698
COPYRIGHT © 2023 ELANCO OR ITS AFFILIATES
_CARTON – BACK PANEL _
DIRECTION FOR USE: Oral doses to be administered once daily, with or
without food.
The recommended dose of cyclosporin is 7 mg/kg body weight (0.07 mL of
oral
solution per kg).
FIRST AID: IF POISONING OCCURS, CONTACT A DOCTOR OR POISONS
INFORMATION CENTRE.
PHONE _AUSTRALIA 13 1126; NEW ZEALAND 0800 764 766_.
DISPOSAL: Dispose of empty containers by wrapping with paper and
putting in
garbage.
STORAGE: Store below 30 °C (room temperature). Do not store below
15 °C. Do not refrigerate. Use the contents within 10 weeks of first
broaching of the
vial. Discard the unused portion. Keep the vial in the outer carton.
APVMA Approval No.: 66305/53338
Elanco Australasia Pty Ltd
ABN 64 076 745 198