Download prescription animal remedy - Novartis Animal Health Inc.

606510 AUS/NZL 910963
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Soft Capsules for Dogs (54354)
Active Constituent: Each capsule contains
10 mg CYCLOSPORIN
Soft Capsules for Dogs (54355)
Active Constituent: Each capsule contains
25 mg CYCLOSPORIN
Soft Capsules for Dogs (54356)
Active Constituent: Each capsule contains
50 mg CYCLOSPORIN
Soft Capsules for Dogs (54357)
Active Constituent: Each capsule contains
100 mg CYCLOSPORIN
INDICATIONS
For the treatment of atopic dermatitis in dogs
Aids in the treatment of perianal fistulae in dogs
Metabolism
Cyclosporin is metabolised mainly in the liver by cytochrome
P450 (CyP3A4), but also in the intestine. A biphasic elimination
is seen: the first phase half-life is short, followed by a much
longer one (>10 hours) which reflects a slow tissue depletion.
Faecal elimination is the major route of drug excretion. Only
10% is excreted through urine, mostly as me­ta­bolites. No
bioaccumulation is observed after repeated adminis­tration.
Atopic dermatitis is one of the most common allergic skin
diseases in dogs. Atopic dermatitis is caused by allergens such
as house dust mites or pollens which stimulate an exaggerated
im­mune response in atopic dogs. Atopy can occur seasonally,
but occurs frequently as a non-seasonal condition with summer
exacerbation. The disease is chron­ic, recurrent and requires
lifelong management, as elimination of exposure to allergens is
gene­rally impossible. Atopic dermatitis may often be complicated
by bacterial or fungal infec­tions. Clinical signs such as pruritus
and skin inflammation are not specific for atopic dermatitis and
therefore other causes of dermatitis should be ruled out, and
serum and/or intradermal allergy testing performed to support the
di­agnosis of atopy.
Perianal fistula (PAF) is a painful, chronic and progressive
inflam­matory disease involving the anal and perianal area of
dogs. PAF is char­acterised by inflammation and ulceration in the
peri­anal skin that progresses to the formation of draining sinuses
and fistulous tracts. Clinical signs include painful defecation and
an unpleasant odour.
PHARMACOLOGICAL PROPERTIES
ATOPICA contains cyclosporin. Cyclosporin is a selective
immunomodulator that acts specifically and reversibly on
T-lymphocytes. Cyclosporin has anti-inflammatory activities in
atopic dermatitis and perianal fistulae in dogs. Cyclosporin acts
specifically and revers­ibly on the cellular immune reaction by
inhibiting resting T-lymphocytes and the antigen-triggered release
of lymphokines by activated T-cells. It also inhibits eosinophil
recruitment and activation, keratinocyte cytokine production,
Langerhans’ cell functions, degranula­tion of mastocytes and
therefore re­lease of histamine and pro-inflammatory cytokines.
Cyclosporin does not depress haematopoiesis and has no effect
on the function of phagocytic cells.
Absorption
ATOPICA capsules spontaneously form a microemulsion in the
pres­ence of gastric fluid. The bioavailability of cyclosporin given
as ATOPICA is approximately 35%. The drug bioavailability is
better in fasted than fed dogs.
Peak plasma levels of the active are reached after 1 to 2 hours,
and the drug is widely distrib­uted into the tissues including the
skin. Cyclosporin is highly protein bound (>90%).
Product
Format
Atopica Pack Size
210 x 297 mm
Element
910963 Mat-Nr
PP Country
Restraint: NOT TO BE USED in food producing species
of animals. (Australian relevant information)
Precautions
Side effects
When used as directed, ATOPICA may cause gastrointestinal
disturbances such as vomiting, mucoid or soft stool and
diarrhoea. Signs are usually mild and transient and generally do
not require treatment be stopped. Occasionally anorexia, gingival
hypertrophy, verruciform lesions, change of hair coat, muscle
cramps or muscle weakness have been reported.
Single oral doses up to 33 mg/kg cyclosporin resulted in no
clinical signs in dogs. Side effects as described above may be
observed during prolonged treatment at greater than 10 mg/kg
daily.
Special precautions for use
The efficacy and safety of cyclosporin has not been assessed in
dogs aged less than 6 months or weighing less than 2 kg. Do
not use in dogs aged less than 6 months or weighing less than
2 kg. The tolerability of ATOPICA has not been studied during
pregnancy and lactation. There is no evidence of teratogenicity of
cyclosporin in laboratory animals. ATOPICA is recommended for
use in breeding dogs only if the benefit/risk ratio is considered
justified by the veterinarian.
It is recommended to clear bacterial and fungal infections before
treatment with ATOPICA. Infections are not necessarily a reason
for drug withdrawal if they occur during treatment.
Cutaneous papillomas characterised by epidermal hyperplasia,
hyperkeratosis and an infiltrate of lymphocytes and plasma cells
have been reported in dogs receiving high doses of cyclosporin
for prolonged periods. Papillomas usually resolve on cessation of
cyclosporin therapy.
As cyclosporin inhibits T-lymphocytes, it may decrease the immune
response in cases of malignancy. A complete clinical examination
should be performed before treatment. Lymphadenopathy or
606510
AUS/NZL
schwarz Doc-Size 100% Print-Size 100%
Colors
Contact
15 caps SINR
DIRECTIONS FOR USE
Nick Gesù
ARTWORK SPECIFICATION
Agency
Inhouse Program
Version
Adobe InDesign CS4
2 Date 06.05.2010
cutaneous lesions observed on treatment with cyclosporin should
be regularly monitored.
In dogs with known hepatic dysfunction, blood levels of
cyclosporin may increase in some cases.
It is recommended to regularly monitor blood glucose levels in
diabetic dogs.
Interaction with other veterinary medicinal products and other
forms of interaction
Various drugs, including ketoconazole, phenobarbitone, and
eryth­romycin are known to competitively inhibit or induce the
enzymes in­volved in the metabolism of cyclosporin, in particular
cytochrome P450 (CyP3A4). In clinically relevant cytochrome
P450-mediated interactions an appropriate adjustment of
ATOPICA dosage may be required. Ketoconazole is known to
lead to a clinically relevant increase of the blood concentration
of cyclosporin in dogs. Phenobarbitone may re­duce the blood
concentration of cyclosporin in dogs. Metoclopramide increases
blood levels of cyclosporin by increasing gastrointestinal
absorption.
Cyclosporin has been shown to have no detrimental effect on
the humor­al immune response or numbers of T-lymphocytes in
young dogs follow­ing vaccination with modified live (attenuated)
vaccines. The effect of cyclosporin on cell-mediated immunity
and protection on challenge following vaccination has not been
evaluated. No conclusive evidence is available concerning the
interaction between cyclosporin and vaccination with a killed
vaccine. Veterinarians should make a risk/benefit decision on
whether to vaccinate animals being treated with ATOPICA.
Dosage and administration
Give ATOPICA orally, without food, at least 2 hours before or
after feeding. Insert the capsule directly into the dog’s mouth.
For the treatment of atopic dermatitis: The recommended
oral daily dose of cyclosporin is 5 mg/kg bodyweight given
according to the table below. These dosages correspond to a
minimum of 3.1 mg/kg and maximum of 6.7 mg/kg. Administer
ATOPICA once daily until a satisfactory clinical improvement is
seen, usually within 4 weeks.
ATOPICA can then be given every second day. Once the clinical
signs of atopic dermatitis are satisfactorily controlled, ATOPICA
can be given every 3 to 4 days. The veterinarian will adjust the
fre­quency of adminis­tration to the response.
Bodyweight
of the dog
Number of capsules given to obtain the recommended dose for atopic dermatitis
ATOPICA 10 mg
ATOPICA
25 mg
ATOPICA
50 mg
ATOPICA
100 mg
–
2 to < 3 kg
1 capsule
–
–
3 to < 4 kg
2 capsules
–
–
–
4 to < 8 kg
–
1 capsule
–
–
8 to <15 kg
–
–
1 capsule
–
15 to <29 kg
–
–
–
1 capsule
–
–
1 capsule
–
–
–
and
1 capsule
2 capsules
FIRST AID: If poisoning occurs, contact a doctor or
Poisons Information Centre
(Phone: Australia 13 1126;
New Zealand 0800 764 766).
WARRANTY
The manufacturer of this animal remedy extends/grants to the
purchaser a warranty that this animal remedy is reasonably fit for
the purposes for which its use is recommended, provided that the
purchaser uses the remedy only for the purposes for which it is
recommended him and strictly in accordance with the directions
on this leaflet.
® Registered trademark of Novartis AG, Basel, Switzerland
NOVARTIS ANIMAL HEALTH AUSTRALASIA PTY LIMITED
54 Waterloo Road,
NORTH RYDE NSW 2113
NOVARTIS CUSTOMER ASSISTANCE Australia
% 1800 633 768 TOLL FREE from anywhere in Australia
8:30 am to 5:30 pm E.S.T. Monday to Friday
NOVARTIS CUSTOMER ASSISTANCE New Zealand
% 0800 588 001 TOLL FREE from anywhere in New Zealand
10:30 am to 7:30 pm Monday to Friday
PRESCRIPTION ANIMAL REMEDY (P.A.R.) Class I
For use only under the authority or prescription of
a vete­r­inarian.
Registered pursuant to the ACVM Act 1997 No. A8300.
See www.nzfsa.govt.nz/acvm for registration conditions.
Registered to Novartis New Zealand Limited,
Building G, 5 Orbit Drive, Rosedale, AUCKLAND 0632
APVMA Approval Nos. 54354/0406, 54355/0406,
54356/0406, 54357/0406
606510 AUS/NZL 910963
29 to <36 kg
36 to 55 kg
As an aid in the treatment of perianal fistulae: Limited
data are available on the use of cyclosporin for the treatment of
perianal fistulae in dogs. The recommended oral daily dose of
cyclosporin is 7.5 mg/kg bodyweight. Side effects such as
vomit­ing, diarrhoea and gingival hypertrophy may be observed
during prolonged treatment at greater than 10 mg/kg daily.
Clinical improvement is usually seen ­within 4 weeks. If no
response is ob­tained within the first 8 weeks, stop the treatment.
Treatment for at least 12 weeks, or until 4 weeks after lesion
resolution, is recommended to minimise recurrence. Concurrent
antibiotics or analgesia may be required. Recurrence may be
managed with a further course of treatment with ATOPICA.
Product
Format
Atopica Pack Size
210 x 297 mm
Element
910963 Mat-Nr
PP Country
606510
AUS/NZL
schwarz Doc-Size 100% Print-Size 100%
Colors
Contact
15 caps SINR
Nick Gesù
ARTWORK SPECIFICATION
Agency
Inhouse Program
Version
Adobe InDesign CS4
2 Date 06.05.2010