ATOPICA 10 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(10mg/Cp)

Pharmaceutical form:

ORAL CAPSULE

Composition:

CYCLOSPORIN BIOLOGICAL-ORGANISM-FUNGUS Active 10.0 mg/Cp

Units in package:

10 Caps; 15 Caps; 30 Caps; 60 Caps

Class:

VM - Veterinary Medicine

Manufactured by:

ELANCO AUSTRALASIA

Therapeutic group:

DOG - LARGE

Therapeutic area:

MISCELLANEOUS VETERINARY

Therapeutic indications:

ATOPIC DERMATITIS | PERIANAL FISTULAE

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - LARGE: [ATOPIC DERMATITIS, PERIANAL FISTULAE]; For the treatment of atopic dermatitis in dogs. Aids in the treatment of perianal fistulae in dogs.NOT TO BE USE in food producing species of animals. See PRECAUTIONS etc. on label.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

ATOPICA
10
mg
Soft Capsules for Dogs
APVMA No.: 54354
ACVM: A008300
Date: 16 December 2013
TEXT
ABOVE
THIS
LINE
IS
NOT
INCLUDED
BLISTER FOIL
(INTERNATIONAL DESIGN
-
SAME BLISTER FOR ALL COUNTRIES)
ATOPICA 10 MG
Ciclosporin
Atopica
10
mg soft capsules for dogs.
For animal treatment only
Page 1
of
7
_RLP _
Approved
ATOPICA
10
mg
Soft Capsules for Dogs
APVMA No.: 54354
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
ATOPICA® 10
MG
SOFT CAPSULES FOR DOGS
Active Constituent: Each Capsule contains 10
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 10 mg Soft Capsules for Dogs
APVMA No
.:
54354
ACVM: A008300
Date: 16 December 2013
Text
ab
ove
this line is not included
CARTON ANCILLARY PANELS
ATOPICA®
10 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
2
to<
3 kg:
10
mg
3 to < 4 kg:
20
mg
[pictogram]
FIRST AID:
IF
POISONING OCCURS, CONTACT A DOCTOR
OR
POISONS INFORMATION CENTRE.
PHONE
AUSTRALIA 131126; NEW ZEALAND 0800 764 766.
DISPOSAL: Dispose
of
empty containers
by
wrapping with paper and putting
in
garbage.
STORAGE: Store below
25
°C (Air Conditioning). Capsules
mu
st be left
in
the blister until required
for
use.
When a blister is opened, a characteristic smell is noticeable, which
is
normal.
AUSTRALIA
No
va
rtis Animal Health Australasia
Pt
y Limited
ACN 64 076 745 198
54 Waterloo Road
NORTH RYDE NSW 2113
APVMA
No.
54354/59475
NOVARTIS CUSTOMER ASSISTANCE Australia
~
1800 633 768 TOLL FREE from anywhere in Australia
8.30 am
to
5.
30
pm E.S.T. Mo

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