Ventipulmin Granules 16 micrograms/gram

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

White granules. Each gram of granules contains 16 micrograms of clenbuterol hydrochloride.

Uses

Treatment of respiratory disease in horses where airway obstruction due to bronchospasm and/or accumulation of mucus is a contributing factor, and improved mucociliary clearance is desirable. To be used alone or as adjuvant therapy.

In particular:

1.Acute, sub-acute and chronic infections where the presence of mucus and/or micro-organisms may stimulate bronchospasm or cause airway obstruction and thus increase airway resistance. For example, bronchitis, bronchiolitis and bronchopneumonia alone, or associated with equine influenza and other viral respiratory diseases.

2.Acute, sub-acute and chronic respiratory allergies.

3.Chronic Obstructive Pulmonary Disease (COPD).

In cases accompanied by bacterial infection the administration of antimicrobial agents is recommended.

Dosage and administration

Administer 5 g Ventipulmin Granules per 100 kg bodyweight twice daily.

This is equivalent to twice daily administration of 0.8 micrograms clenbuterol per kg bodyweight.

The granules should be added to the feed. A measuring scoop is provided with the 500 g pack. When full, the scoop contains 10 g. A scored line on the scoop indicates a half measure (5 g). Add to feed immediately before administration. Discard any remaining medicated feed.

Treatment should continue for as long as necessary.

Contra-indications, warnings, etc

Do not use in horses with known cardiac disease or known hypersensitivity to the active ingredient. Clenbuterol may cause side effects such as sweating (mainly neck region), muscle tremor, tachycardia, slight hypotension or restlessness. These are typical for β-agonists and occur rarely.

Ventipulmin antagonises the effects of prostaglandin F2α and oxytocin.

Ventipulmin is antagonised by β-adrenergic blocking agents.

If used during pregnancy, treatment must be discontinued at the expected time of delivery since uterine contractions may be abolished under its influence.

Dosages of clenbuterol hydrochloride up to 4 times the therapeutic dose (administered orally) for a period of 90 days caused transient side effects typical for beta2-adrenoceptor agonists (sweating, tachycardia, muscle tremor), which required no treatment. In case of accidental overdose, a β-blocker (such as propranolol) may be used as antidote.

Withdrawal period

Animals must not be slaughtered for human consumption during treatment. Horses may be slaughtered for human consumption only after 28 days from the last treatment.

This product contains clenbuterol, a β-agonist. Take care to avoid skin contact. In case of skin contact wash affected area thoroughly. If irritation occurs/persists seek medical advice. Take care to avoid accidental eye contact. In the case of accidental eye contact, flush thoroughly with clean water and seek medical advice. When using do not eat, drink or smoke. Wash hands thoroughly after using the product. Avoid inhaling dust.

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

For animal treatment only. Keep out of the reach and sight of children.

Pharmaceutical precautions

Protect from light. Do not store above 30°C.

Legal category

POM-V

Packaging Quantities

Screw top polythene bottle containing 500 g granules.

Further information

The product contains the active ingredient clenbuterol hydrochloride which is a sympathomimetic amine with a high degree of selectivity for the B2-receptor sites in the body, thus providing intense bronchodilating properties with minimum effect on the cardiovascular system. It has been shown to stimulate mucociliary clearance in horses.

The effects on pulmonary function and clinical response have been assessed in clinical trials with horses suffering from a variety of respiratory conditions.

A marked decrease in intrathoracic pressure, a decrease in respiratory rate, an initial decrease followed by an increase in arterial oxygen partial pressure and clinical improvements were observed.

In addition, a significant reduction in resistance to airflow and a clinical improvement in the animals respiratory pattern were seen.

The active substance is well absorbed following oral administration. Oral and parenteral dose rates are identical at 0.08 micrograms per kg bodyweight.

Marketing authorisation number

Vm 00015/4040.