Danilon Equidos Gold Sachets

Danilon Equidos Gold Sachets for Horses

Target species
Horses and ponies.

4.2 Indications for use, specifying the target species

Treatment of pain and inflammation associated with musculo-skeletal conditions in
the horse eg osteoarthritic conditions, bursitis, laminitis and soft tissue inflammation.

4.3 Contraindications

Do not use in animals with renal, hepatic or cardiac disorders.
Do not use in animals where there is the possibility of gastro-intestinal ulceration or
bleeding.
Do not use in animals where there is evidence of a blood dyscrasia.
Do not use in known cases of hypersensitivity to the active substance or any of the
excipient

4.4 Special warnings for each target species

NSAIDs can cause inhibition of phagocytosis and hence, in the treatment of
inflammatory conditions associated with bacterial infections appropriate antimicrobial
therapy should be instigated.
Revised: February 2022
AN: 02680/2021
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4.5 Special precautions for use

Special precautions for use in animals
Do not exceed the stated dose or duration of treatment. Dosage should be kept to a
minimum for alleviation of symptoms.
During treatment of very young animals (less than 12 weeks) where development of
their hepatic or renal function may be incomplete, or in aged animals which may have
these functions impaired, as well as in ponies, additional risk may be involved. In
these cases, the posology should be adjusted and patients monitored closely.
During treatment, do not restrict the consumption of water. Avoid use in any
dehydrated, hypovolaemic or hypotensive animals as there may be an increased risk
of renal failure.

Special precautions to be taken by the person administering the veterinary
medicinal product to animals

Tartrazine may cause allergic reactions
In case of known hypersensitivity to suxibuzone or any of the excipients, avoid
contact with the product.
Wash hands after use.
Use in a well-ventilated area. To avoid exposure to the granules, part-sachets
should not be used. Avoid inhaling any dust when opening sachet and mixing with
feed. Avoid contact with skin, eyes and mucosa. In case of accidental contact, wash
with plenty of clean water. In case of accidental ingestion, seek medical advice
immediately and show this label to the physician.

4.6 Adverse reactions (frequency and seriousness)

After continued use, or at high doses gastro-intestinal changes may occur (very rare
frequency). With a very rare frequency blood dyscrasias and renal alterations may be
found, especially in animals with restricted access to water.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports)

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during
pregnancy, lactation or lay, therefore use during this period is not recommended.

4.8 Interaction with other medicinal products and other forms of interaction

Suxibuzone and its metabolites may be highly bound to plasma proteins and compete
with other highly bound drugs eg sulphonamides, warfarin; or it may itself be displaced
to produce an increase of non-bound pharmacologically active concentrations which
could lead to toxic effects. Drug compatibility must be closely monitored when
adjunctive therapy is required.
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AN: 02680/2021
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Do not administer together with other NSAIDs concurrently or within 24 hours of each
other.
Concurrent administration of potentially nephrotoxic drugs should be avoided.

4.9 Amounts to be administered and administration route

For oral administration.
When added to a portion of feed the product will be accepted by most horses.
The following should be used as a guide, according to individual response:
Horses
For a 480 kg bodyweight horse, the contents of 2 sachets should be administered
twice daily (equivalent to 12.5 mg of suxibuzone/kg/day) for 2 days, followed by 1
sachet twice daily (6.25 mg of suxibuzone/kg/day) for 3 days.
Thereafter, 1 sachet daily (3.1 mg of suxibuzone/kg/day) or on alternate days, or the
minimum dose frequency necessary for a satisfactory clinical response.
Ponies
Ponies should receive only half the dose rate recommended for horses.
For a 240 kg bodyweight pony, the contents of 1 sachet should be administered daily
(equivalent to 6.25 mg of suxibuzone/kg/day) for 2 days, followed by 1 sachet on
alternate days.
Thereafter, reduce to the minimum dose frequency necessary for a satisfactory clinical
response.
Hay, as part of the diet, may delay the absorption of suxibuzone and so the onset of
clinical effect. It is advisable not to feed hay immediately prior to, or with the veterinary
medicinal product.
See also 4.5.
If no clinical response is evident after 4-5 days, discontinue treatment and reconsider
the diagnosis.
Part sachets should not be used.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of accidental continuous overdose, the following symptoms may be observed:
• Thirst, depression, anorexia and weight loss
• Gastrointestinal disorders (irritation, ulcers, diarrhoea and blood in the faeces)
• Altered blood profiles and haemorrhages
• Hypoproteinemia with ventral oedema causing hemoconcentration, hypovolemic
shock and circulatory collapse.
• Renal failure and fluid retention.
If signs of intolerance appear, discontinue treatment and establish symptomatic
therapy.
A slow intravenous perfusion of a solution of sodium bicarbonate, which leads to urine
alkalinisation, increases the clearance of the product.

4.11 Withdrawal period

Not to be used in animals intended for human consumption.
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AN: 02680/2021
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Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under
national horse passport legislation.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiinflamatory and Antirheumatic Products, Nonsteroids
ATC vet code: QM01AA90

5.1 Pharmacodynamic properties

Suxibuzone is a Non-Steroidal Anti-inflammatory Drug (NSAID) synthetically derived
from pyrazolone with anti-inflammatory, antipyretic and analgesic properties with low
ulcerogenic potential.
When mixed with concentrate feed, the product was shown to be palatable to horses.
Its mechanism of action is based on the inhibition of the cyclooxygenase (enzyme
which catalyzes the synthesis of prostaglandins, prostacyclines and thromboxanes
from arachidonic acid). The therapeutic effects are mainly due to the inhibition of the
biosynthesis of prostaglandines, which act as peripheral mediators of pain and trigger
the synthesis of endogen pyrogens and mediators in the inflammatory process. It also
inhibits platelet aggregation.
The therapeutic effect of suxibuzone relies entirely on the activity of its active
metabolites. Strong anti-inflammatory activity has been shown for phenylbutazone
and oxyphenbutazone. The third metabolite -hydroxyphenbutazone is considered to
be pharmacologically inactive.

5.2 Pharmacokinetic particulars

After oral administration suxibuzone is readily absorbed and most of it is metabolised
by the hepatic microsomal system producing phenylbutazone, oxyphenbutazone and
-hydroxyphenylbutazone. No unaltered parent compound can be detected in plasma
after oral administration of suxibuzone to horses. These active metabolites have a
high degree of affinity for plasma proteins and are eliminated mainly through urine, as
glucoronide conjugates, but also, in a small percentage, through faeces. Less than 1%
is eliminated through saliva and milk.
After the administration of a single 6.25 mg/kg oral dose of the parent compound
phenylbutazone reaches its maximum plasma concentration (9.9±2.3 µg/ml) at 11±3
hours after administration with an elimination half life of 7.1±0.5 h. Oxyphenbutazone
reaches its maximum (1.5±0.4 µg/ml) at 15±5 hours after administration.
As happens with other NSAID´s the duration of the clinical response is much longer
than the plasma half-life. Significant concentrations of both active metabolites are
found in synovial fluid for at least 24 hours after administration.
Revised: February 2022
AN: 02680/2021
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6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tartrazine (E102)
Mannitol
Sucrose
Povidone K-30
Sodium saccharin
Ethyl Cellulose 20

6.2 Major incompatibilities

Not applicable.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 4 years

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

3 g laminated opaline/aluminium polyethylene sachets
Cartons containing 18 or 60 sachets
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product
or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such
veterinary medicinal products should be disposed of in accordance with local
requirements.