Suspension for Injection

COMPOSITION
Each 1 ml of the suspension contains 1,07 mg dexamethasone dimethylbutyrate (equivalent to 0,85 mg dexamethasone) 
Preservative:  2,0 % m/v Benzyl alcohol

PHARMACOLOGICAL CLASSIFICATION
C 22.3 Corticosteroids and analogues

PHARMACOLOGICAL ACTION
Dexamethasone is a corticosteroid with anti-inflammatory and gluconeogenic properties, and little mineralcorticoid activity.  Corticosteroids influence protein, carbohydrate and fat metabolism, electrolyte and water balance and the functional capabilities of the cardiovascular system,the kidneys and skeletal muscles, the nervous system and other organs and tissues.

INDICATIONS
Musculoskeletal Conditions
Dexamedium is indicated, in selected cases, for suppression of the clinical manifestations (such as pain, swelling and effusion) of acute, localised and generalised arthritic conditions.
Allergic Conditions
May be used for the symptomatic treatment of allergic conditions of the skin and respiratory system in dogs and cats.
Primary Ketosis (Acetonaemia)
Dexamedium is indicated in treating primary ketosis in cattle.

CONTRA-INDICATIONS
Dexamedium should not be used in pregnancy unless termination of pregnancy is desired or acceptable.
Dexamedium is contra-indicated in animals with gastric ulcerations, corneal ulcerations/perforations, cardiac insufficiency, healing wounds, laminitis, diabetes mellitus, osteoporosis and renal disease other than the nephritic syndrome.

WARNING
Abortion may occur in animals of treated in the last trimester of pregnancy.

WITHDRAWAL PERIOD
Milk: 12 hours following last treatment
Meat: 24 days following last treatment

DOSAGE AND DIRECTIONS FOR USE
Cattle : 10 ml
Dog : 0,5 – 1,0 ml per 10 kg body mass
Cat : 0,5 – 1,0 ml per 10 kg body mass
Shake the vial before use
In all species, Dexamedium should be administered by intramuscular injection using aseptic techniques.
One treatment is usually sufficient.
If required, treatment may be repeated after 4 days.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Treatment with Dexamedium may cause:
 Abortion
 Suppression of the immune system
 Gastric ulcerations
 Colonic perforation
 Impaired wound healing
 Hypokalaemia
 Retention of sodium and fluids
 Congestive heart failure in susceptible patients
 Hyperadrenocorticism
 Secondary hypoadrenocorticism
 Opthalmic disease like glaucoma and cataracts
 Fall in milk production
 Loss of muscle mass
 Crystal induced synovitis after intra-articular injections

In addition, the use of Dexamedium may prevent a correct diagnosis due to:
 Suppression and masking of clinical manifestations
 Alteration of certain haematological and blood chemistry parameters
 Suppression of reactions to skin tests

Where infection is a possibility, it is essential that Dexamedium therapy should be accompanied by effective and specific antimicrobial treatment.

Due to the relatively long action and potency of the preparation, there is a marked suppression of the hypothalamo-ptuitary-adrenal axis after even a single injection.

Whilst receiving Dexamedium therapy, animals should not be vaccinated except under special circumstances.

Dietary salt restriction and potassium supplementation may be necessary while the animal is being treated with Dexamedium.  In animals with severe hepatic disease, the effects of Dexamedium may be altered.

KNOWN SIGNS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdosage for an extended period will result in hyperadrenocorticism.  Adrenal stimulation is advisable using a short-acting corticosteroid.  Sudden withdrawal of treatment may result in hypoadrenocorticism.

IDENTIFICATION
White, aqueous, homogenous suspension.

STORAGE INSTRUCTIONS
Store between 15 – 25 ºC in the dark.
KEEP OUT OF REACH OF CHILDREN AND UNINFORMED PERSONS.

PRESENTATION
50 ml multidose vial.

REGISTRATION HOLDER
Intervet S.A. (Pty) Ltd
Co. Reg. No. 1991/006580/07