ATOPICA 25 MG SOFT CAPSULES FOR DOGS

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(25mg/Cp)

Pharmaceutical form:

ORAL CAPSULE

Composition:

CYCLOSPORIN BIOLOGICAL-ORGANISM-FUNGUS Active 25.0 mg/Cp

Units in package:

10 Caps; 15 Caps; 30 Caps; 60 Caps

Class:

VM - Veterinary Medicine

Manufactured by:

ELANCO AUSTRALASIA

Therapeutic group:

DOG - SMALL OR TOY | DOG - SMALL | DOG - TOY

Therapeutic area:

MISCELLANEOUS VETERINARY

Therapeutic indications:

ATOPIC DERMATITIS | PERIANAL FISTULAE

Product summary:

Poison schedule: 4; Withholding period: whp: n/a; Host/pest details: DOG - SMALL OR TOY: [ATOPIC DERMATITIS, PERIANAL FISTULAE]; For the treatment of atopic dermatitis in dogs. Aids in the treatment of perianal fistulae in dogs.NOT to be used in food producing species of animals.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

ATOPICA
25
mg Soft Capsules for Dogs
APVMA No.: 54355
ACVM: A008300
Date: 16 December 2013
Text above this line is not included
Blister
foil
(international
design
-
same
blister
for
all
countries)
ATOPICA 25
mg
Ciclosporin
Atopica
25
mg soft capsules for dogs.
For animal treatment only
Page 1
of
7
RLP
.A.pproved
A TO PICA 25 mg Soft Capsules for Dogs
APVMA No.: 54355
ACVM: A008300
Date: 16 December 2013
Text above this line
is
not included
Carton
front
panel
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
A TO
PICA®
25
MG
SOFT CAPSULES FOR DOGS
Active Constituent: Each Capsule contains 25
mg
CYCLOSPORIN
Page 2
of
7
For the treatment
of
atopic dermatitis
in
dogs. Aids
in
the treatment
of
perianal
fistulae in dogs.
[graphic
of
small breed dog]
Contents: 15 Soft Capsules
ATOPICA
25
mg
Soft Capsules for Dogs
APVMA No.: 54355
ACVM: A008300
Date: 16 December 2013
TEXT
ABOVE
THIS
LINE
IS
NOT
INCLUDED
CARTON ANCI/LARV PANELS
ATOPICA®
25
mg Soft Capsules for Dogs
REFER TO ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE
RESTRAINT: NOT TO BE USED
IN
FOOD PRODUCING SPECIES
OF
ANIMALS.
Give ATOPICA without food, at least 2 hours before or after feeding.
Dosage
Page 3
of
7
Atopic dermatitis: 5
mg
cyclosporin per kg bodyweight daily using the appropriate combination
of
capsules
4
to
<
8
kg:
25
mg
8
to
<
15
kg:
50
mg
[pictogram]
FIRST AID: IF POISONING OCCURS, CONTACT A DOCTOR OR POISONS
INFORMATION CENTRE.
PHONE
AUSTRALIA 131126;
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.
AUSTRALIA
Novartis Animal Health Australasia Ply Limited
ACN 64 076 745 198
54 Waterloo Road
NORTH RYDE NSW 2113
APVMA
No.
54355/59477
NOV
ARTIS CUSTOMER ASSISTANCE Australia
'LI
1800 633 768 TOLL FREE from anywhere
in
Australia
8.30
am
to
5.30
pm
E.S.T. Mond

Summary of Product characteristics

PRODUCT NAME: ATOPICA® SOFT CAPSULES FOR DOGS
(10MG/25MG/50MG/100MG)
PAGE: 1 OF 5
THIS REVISION ISSUED: NOVEMBER, 2013
SAFETY DATA SHEET
Issued by: Novartis Animal Health Australasia Pty Ltd.
Phone: [phone] (office hours)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LTD.
ABN 64 076 745 198
TELEPHONE [phone]
(OFFICE HOURS)
54 WATERLOO RD
FAX [phone]
NORTH RYDE, NSW 2113
CHEMICAL NATURE:
Peptide derived from certain fungi, used as an immunosuppressant.
TRADE NAME:
ATOPICA® SOFT CAPSULES FOR DOGS (10MG/25MG/50MG/100MG)
APVMA CODE:
54354 (10mg), 54355 (25mg), 54356 (50mg), 54357 (100mg)
DIFFERENT SIZES ARE MEANT FOR VARIOUS SIZES OF DOGS AS INDICATED ON
THE PRODUCT LABELS.
PRODUCT USE:
A soft gel capsule for the treatment of atopic dermatitis in dogs.
CREATION DATE:
NOVEMBER, 2013
THIS VERSION ISSUED:
NOVEMBER, 2013
and is valid for 5 years from this date.
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Xn, Harmful. Hazardous according to the criteria of SWA.
Not a Dangerous Good according to the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES: R22, R68. Harmful if swallowed. Possible risk or irreversible
effects.
SAFETY PHRASES:
S20, S22, S36, S24/25. When using, do not eat or drink. Do not breathe
dust. Wear
suitable protective clothing. Avoid contact with skin and eyes.
SUSMP CLASSIFICATION:
S4
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
GHS SIGNAL WORD: WARNING
HAZARD STATEMENT:
H302: Harmful if swallowed.
H371: May cause damage to organs.
PREVENTION
P102: Keep out of reach of children.
P260: Do not breathe dusts.
P264: Wash contacted areas thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P281: Use personal protective equipment as required.
RESPONSE
P301+P312: IF SWALLOWED: Call a POISON CENTRE or doctor if you