PHENYLJECT Solution for parenteral administration
Contains per ml:
Phenylbutazone 200 mg.
Excipients ad 1 ml.
Phenylbutazone is a pyrazolone derivative belonging to the group of antipyretic analgesics with besides analgesic and antipyretic also antiflogistic properties (NSAIDs). Phenylbutazone acts by inhibiting the production of prostaglandins.
Phenylject is indicated for the treatment of musculo-skeletal disorders in horses where the antiinflammatory and analgesic properties of phenylbutazone can offer relief against inflammation, pain and lameness (e.g. osteoarthritis, acute and chronic laminitis, bursitis and carpitis).
The therapeutic index of phenylbutazone is low. Do not exceed the stated dose or the duration of treatment.
Do not administer with other NSAIDs concurrently or within 24 hours of each other.
Do not use in animals suffering from cardiac, hepatic or renal disease; where there is the possibility of gastrointestinal ulceration or bleeding; where there is evidence of blood dyscrasias or hypersensitivity to the product.
Use during pregnancy should be avoided whenever possible, particularly during the first trimester.
Non-steroidal anti-inflammatory drugs can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infection, appropriate concurrent antimicrobial therapy should be instigated.
There is a risk of irritancy if the injection is accidentally inoculated under the skin during intravenous administration.
Rarely, collapse following intravenous injection has been reported. The product should be injected slowly over as long a period as is reasonably practical. At the first signs of intolerance, the administration of the injection should be interrupted.
Some non-steroidal anti-inflammatory agents may be highly bound to plasma proteins and compete with other highly bound drugs to produce an increase in non-bound pharmacologically active concentrations which can lead to toxic effects.
Gastrointestinal tract ulceration may be exacerbated by corticosteroids in animals given nonsteroidal anti-inflammatory drugs.
Concurrent administration of potential nephrotoxic drugs (e.g. aminoglycoside antibiotics) should be avoided.
For very slow intravenous administration.
Horses: 1 ml per 45 kg (4.4 mg phenylbutazone/kg), with a maximum of 10 ml.
To be administered in a single dose, which may be followed if necessary by oral phenylbutazone therapy commencing 24 hours after the injection. In acute cases and in hospitalised animals it may be administered once daily for not more than five consecutive days. Observe aseptic conditions.
Not to be used in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
Brown type II glass bottle of 100 ml, closed with type I butylsepta and aluminium caps.