Ventipulmin Injection Solution

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 aqueous solution for injection. Each ml contains 30 micrograms clenbuterol hydrochloride and 10 mg benzyl alcohol as preservative.

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 anti microbial agents is recommended.

Dosage and administration

By slow intravenous injection. Twice daily administration of 2.7 ml of the injection per 100 kg bodyweight. This is equivalent to twice daily administration of 0.8 micrograms of clenbuterol hydrochloride per kg bodyweight. Treatment should continue for as long as necessary. Avoid the introduction of contamination during use.

Contra-indications, warnings, etc

Ventipulmin antagonises the effects of prostaglandin F2-alpha and oxytocin.

Ventipulmin is antagonised by beta-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.

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.

Do not use in cases of known sensitivity to clenbuterol. Sweating and transient mild muscle tremor may occur after intravenous administration in some horses. It is suggested that a may be responsible for this, causing transient peripheral vasodilation.

Vasodilation is a feature of all beta-adrenergic drugs to a greater or lesser degree and may be minimised by administering Ventipulmin slowly.

When using do not eat, drink or smoke. After use wash any contaminated skin immediately with soap and clean water.

This product contains clenbuterol, a beta-agonist. Accidental self-injection may produce tachycardia and tremor. These effects may be reversed by the use of a non-selective beta-blocker. If accidental self-injection occurs seek medical advice immediately avoiding driving if possible. Unused product and containers should be disposed of in accordance with national requirements.

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 withdrawal of the first dose use the product within one month. Discard unused material. Avoid the introduction of contamination during use. Should any growth or discolouration occur the product should be discarded.

Legal category

POM-V

Packaging Quantities

Amber vials with pink bromobutyl stoppers containing 50 ml of solution.

Further information

Nil.

Marketing authorisation number

Vm 00015/4039.