ATOPICA 100 MG SOFT CAPSULES FOR DOGS

Country: Ավստրալիա

language: անգլերեն

source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

active_ingredient:

CYCLOSPORIN

MAH:

ELANCO AUSTRALASIA PTY LTD

INN:

cyclosporin(100mg/Cp)

pharmaceutical_form:

ORAL CAPSULE

composition:

CYCLOSPORIN BIOLOGICAL-ORGANISM-FUNGUS Active 100.0 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_indication:

ATOPIC DERMATITIS | PERIANAL FISTULAE

leaflet_short:

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

PIL

A TO PICA 100 mg Soft Capsules for Dogs
APVMA No.: 54357
ACVM: A008300
Date: 15 December 2013
TEXT
ABOVE
THIS
1INE
IS
NOT
INCLUDED
BLISTER FOIL
(INTERNATIONAL DESIGN
-
SAME
BLISTER FOR ALL COUNTRIES)
ATOPICA 100 MG
Ciclosporin
Atopica 100 mg soft capsules for dogs.
For animal treatment only
Page 1
of
7
+
RLP
·
;Jproved
ATOPICA 1
DO
mg
Soft Capsules for Dogs
APVMA No.: 54357
ACVM: A008300
Date: 15 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
®
1 00
MG
SOFT CAPSULES FOR DOGS
Active Constituent: Each Capsule contains 100
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 1
DO
mg
Soft Capsules for Dogs
APVMA No.: 54357
ACVM: A008300
Date: 15 December 2013
TEXT
ABOVE
THIS
LINE
IS
NOT
INCLUDED
CARTON ANCILLARY PANELS
A TO PICA®
1
DO
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 A TO PICA 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
15
to<
29
kg:
100
mg
29
to<
36
kg:
150
mg
36
to
55
kg:
200
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
i.s
opened, a characteristic smell
is
noticeable, which
is
normal.
AUSTRALIA
Novartis Animal Health Australasia Ply Limited
CAN 64 076 745 198
54 Waterloo Road
NORTH RYDE NSW 2113
APVMA
No.
54357/59478
NOV ARTIS CUSTOMER ASSISTANCE Australia
LIII'
1800 633 768 TOLL FREE from anywher

SPC

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