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

A clear colourless syrup. Each ml contains 25 micrograms clenbuterol hydrochloride as active ingredient plus 1.8 mg methyl parahydroxybenzoate and 0.2 mg propyl parahydroxybenzoate as preservatives.

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 concurrent administration of antimicrobial agents is recommended.

Dosage and administration

For Oral Use. Twice daily administration of 4 ml Ventipulmin Syrup per 125 kg bodyweight.

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

The syrup should be added to the feed (one depression of the pump delivers 4 ml syrup).

Treatment should continue for as long as necessary.

Contra-indications, warnings, etc

Known hypersensitivity to the active ingredient or any of the excipients. 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.

Do not use in horses with known cardiac disease.

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.

Doses up to 8 times the therapeutic dose of clenbuterol hydrochloride for a period of 90 days caused only transient side effects typical of β-agonists, which required no treatment. In cases 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. When using do not eat, drink or smoke. Take care to avoid skin contact. In case of skin contact wash affected are 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.

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

Do not store above 25°C. Protect from light. Following opening of the pack use the product within 30 days. Discard unused material.

Legal category

POM-V

Packaging Quantities

Screw top polythene bottle containing 355 ml syrup with 4 ml pump dispenser.

Further information

Nil.

Marketing authorisation number

Vm 00015/4032.