Ventipulmin Granules 16 micrograms/gram

Composition

Each gram contains

Active substance:

Clenbuterol hydrochloride 16 micrograms

Excipients:

For a full list of excipients, see section 6.1

6.1 List of excipients

Mannitol

Lactose Monohydrate

Maize Starch, Dried

Povidone

Maize Starch, Soluble

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Pharmaceutical form

Granules.

White, finely grained free flowing granules.

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Pharmacological properties

ATC Vet code : QR03CC13

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.

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Target species

Horses

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Indications

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 :

i) Acute, sub-acute and chronic infections where the presence of mucus and/or micro- organisms may stimulate bronchospasm or cause airway obstruction and thus an increase in airway resistance. For example, bronchitis, bronchiolitis and bronchopneumonia alone, or associated with equine influenza and other viral respiratory diseases. ii) Acute, sub-acute and chronic respiratory allergies. iii) Chronic Obstructive Pulmonary Disease (COPD) in horses.

In cases complicated by the presence of micro-organisms the simultaneous use of antimicrobial agents is indicated.

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Dosage

For oral administration.

Twice daily administration of 0.8 micrograms clenbuterol per kg bodyweight, for as long as necessary. This is equivalent to twice daily administration of 5g granules per 100kg bodyweight.

The granules should be added to the feed.

Add to feed immediately before administration. Discard any remaining medicated feed.

A measuring scoop is provided with the 500g pack. When full, the scoop contains 10g. A second line on the scoop indicates a half measure (5g).

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Contraindications

None known

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Adverse reactions

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.

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Warnings

Not applicable.

(i) Special precautions for use in animals Do not use in animals with known hypersensitivity to the active substance.

Special precautions to be taken by the person administering the veterinary medicinal product to animals.

This product contains clenbuterol, a beta-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.

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Use during pregnancy, lactation or lay

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

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Interactions

Ventipulmin antagonises the effects of prostaglandin F2 -alpha and oxytocin. Ventipulmin is antagonised by β-adrenergic blocking agents.

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Overdose

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.

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Special warnings

Do not use in horses with known cardiac disease

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Withdrawal period

Meat and offal: 28 days

Do not use in animals producing milk for human consumption

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Incompatibilities

None known

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Immediate packaging

The product is packed in a polyethylene container with a push-fit polyethylene cap. The container is filled with 500 g granules. A polystyrene measuring spoon, graduated at 5g and 10g is also supplied.

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Storage

Do not store above 30°C. Protect from light. Discard unused material.

Add to feed immediately before administration.

Discard remaining medicated feed.

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Shelf life

Shelf life of the medicinal product as packaged for sale: 3 years.

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Disposal of unused product

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

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Additional information

Vm 08327/5058

9 DATE OF FIRST AUTHORISATION

22 August 1994

10 DATE OF REVISION OF THE TEXT

August 2025

Gavin Hall Approved: 22 August 2025

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Registration holder

Boehringer Ingelheim Animal Health UK Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

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