Atopica Soft Capsules for Dogs

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. 95.24 g/litre

Therapeutic area:

Anti-inflammatory

Authorization status:

ACVM Registered

Authorization date:

2001-11-15

Summary of Product characteristics

COMPANY CONFIDENTIAL
PRODUCT NAME: Atopica (10 mg)
PAGE: 1 of 9
REVISION DATE: 22 Feb 2024
COUNTRY: New Zealand
Text above this line is not included in the actual label.
COPYRIGHT © 2024 ELANCO OR ITS AFFILIATES
_CARTON – FRONT PANEL _
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
ATOPICA™ 10 MG
Soft Capsules for Dogs
ACTIVE CONSTITUENT: EACH CAPSULE CONTAINS 10 MG CYCLOSPORIN.
FOR THE TREATMENT OF ATOPIC DERMATITIS IN DOGS.
AIDS IN THE TREATMENT OF PERIANAL FISTULAE IN DOGS.
[graphic of small breed dog]
CONTENTS: 30 (10, 15, 60) SOFT CAPSULES
ELANCO LOGO
COMPANY CONFIDENTIAL
PRODUCT NAME: Atopica (10 mg)
PAGE: 2 of 9
REVISION DATE: 22 Feb 2024
COUNTRY: New Zealand
Text above this line is not included in the actual label.
COPYRIGHT © 2024 ELANCO OR ITS AFFILIATES
_CARTON – ANCILLARY PANEL_
ATOPICA™ 10 MG
Soft Capsules for Dogs
REFER TO LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE
Give ATOPICA orally, without food, at least 2 hours before or after
feeding. Insert the
capsule directly into the dog’s mouth.
RESTRAINT: NOT TO BE USED IN FOOD PRODUCING SPECIES OF ANIMALS.
(Australian
relevant information).
DOSAGE
Atopic dermatitis: 5 mg cyclosporin per kg body
weight daily using the appropriate
combination of capsules.
2 to < 3 kg: 10 mg
3 to < 4 kg: 20 mg
[Pictogram of a small dog]
FIRST AID: IF POISONING OCCURS, CONTACT A DOCTOR OR POISONS
INFORMATION CENTRE.
PHONE: AUSTRALIA 13 11 26; NEW ZEALAND 0800 764766.
DISPOSAL
Dispose of empty containers by wrapping with paper and putting in
garbage.
STORAGE
Store below 25
°
C (air conditioning). Capsules must be left in the blister until
required
for use. When a blister is opened, a characteristic smell is
noticeable, which is normal.
ELANCO AUSTRALASIA PTY LTD, 7 EDEN PARK DRIVE, MACQUARIE PARK, NSW
2113,
AUSTRALIA.
[Trademark statement].
APVMA No. 54354/121184
Product Support Line: 1800 995 709 TOLL FREE
COMPANY CONFIDENTIAL
PRODUCT NAME: Atopica (10 mg)
PAGE: 3 of 9
REVISION DATE: 22 Feb 2024
COUNTRY: New Zealan