Introduction

Company name: Boehringer Ingelheim Limited

Address: Ellesfield Avenue

Bracknell

Berkshire RG12 8YS

Telephone: Sales & Marketing Enquiries 01344 746959

Telephone: Technical Enquiries 01344 746957

Fax: 01344 741349

Presentation

Sterile injectable white suspension. Each ml contains 3 mg dexamethasone-21-isonicotinate and antimicrobial preservatives methyl hydroxybenzoate 1.35 mg/ml and propyl hydroxybenzoate 0.15 mg/ml.

Uses

Voren 14 contains a potent long acting corticosteroid. Voren 14 has glucogenic, anti-inflammatory and anti-allergic properties and may be useful in the treatment of a wide range of conditions in horses, cats and dogs. For example, inflammatory disease of the locomotor and respiratory system and in inflammatory skin conditions.

Dosage and administration

By intramuscular injection. Shake well before use.

Horses

8–12 ml (1 ml/50 kg bodyweight, i.e. 3 mg/50 kg bodyweight).

Dogs (over 20 kg)

2–3 ml (0.075 ml/kg bodyweight, i.e. 0.225 mg/kg bodyweight).

Cats and small dogs

0.4–2 ml (0.1 ml/kg bodyweight, i.e. 0.3 mg/kg bodyweight).

The first beneficial effects are seen 24 hours after injection. If a second injection is necessary, this should be given 14 days after the first treatment.

An appropriately graduated syringe, such as an insulin syringe, must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes.

Contra-indications, warnings, etc

Anti-inflammatory corticosteroids, such as dexamethasone, are known to exert a wide range of side-effects. Whilst single high doses are generally well tolerated, they may induce severe side-effects in long term use and when esters possessing a long duration of action are administered. Dosage in medium to long term use should therefore generally be kept to the minimum necessary to control symptoms. Steroids during treatment, may cause Cushingoid symptoms involving significant alteration of fat, carbohydrate, protein and mineral metabolism, e.g. redistribution of body fat, muscle weakness and wastage and osteoporosis may result.

During therapy effective doses suppress the Hypothalamo-Pituitreal-Adrenal axis. Following cessation of treatment, symptoms of adrenal insufficiency extending to adrenocortical atrophy can arise and this may render the animal unable to deal adequately with stressful situations. Consideration should therefore be given to means of minimising problems of adrenal insufficiency following the withdrawal of treatment, e.g. dosing to coincide with the time of the endogenous cortisol peak (i.e. in the morning with regard to dogs and the evening re: cats) and a gradual reduction of dosage (for further discussion see standard texts).

Systemically administered corticosteroids may cause polyuria, polydipsia and polyphagia, particularly during the early stages of therapy. Some corticosteroids may cause sodium and water retention and hypokalaemia in long term use. Systemic corticosteroids have caused deposition of calcium in the skin (calcinosis cutis).

Corticosteroids are not recommended for use in pregnant animals. Administration in early pregnancy is known to have caused foetal abnormalities in laboratory animals. Administration in late pregnancy may cause early parturition or abortion.

Corticosteroids may delay wound healing and the immunosuppressant actions may weaken resistance to or exacerbate existing infections. In the presence of bacterial infection, anti-bacterial drug cover is usually required when steroids are used. In the presence of viral infections, steroids may worsen or hasten the progress of the disease.

Systemic corticosteroid therapy is generally contra-indicated in patients with renal disease and diabetes mellitus. Gastrointestinal ulceration has been reported in animals treated with corticosteroids and g.i.t. ulceration may be exacerbated by steroids in patients given non-steroidal anti-inflammatory drugs and in corticosteroid treated animals with spinal cord trauma. Steroids may cause enlargement of the liver (hepatomegaly) with increased serum hepatic enzymes.

The product is contra-indicated for the treatment of laminitis in horses. Additionally it should be noted that the use of the product in horses for other conditions could induce laminitis and careful observations during the treatment period should be made.

During a course of treatment the situation should be reviewed frequently by close veterinary supervision.

Withdrawal period:

Not to be used in horses intended for human consumption. 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.

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority. For animal treatment only. Keep out of the reach and sight of children.

Pharmaceutical precautions

Protect from frost. Store below 25°C.

Following withdrawal of the first dose, use the product within 28 days, after which discard any unused material.

Avoid the introduction of contamination during use. Should any apparent growth or discoloration occur, the product should be discarded. Care should be taken to avoid accidental self injection.

Legal category

POM-V

Packaging Quantities

50 ml multidose glass injection bottles.

Further information

Nil.

Marketing authorisation number

Vm 00015/4036.