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Date: Thursday, October 10, 2024 11:38

Release 3.120
Ventipulmin Granules 16 micrograms/gram
 
Species: Horses only
Therapeutic indication: Pharmaceuticals: Cardiovascular and respiratory preparations
Active ingredient: Clenbuterol
Product:Ventipulmin® Granules 16 micrograms/gram
Product index: Ventipulmin Granules
Withdrawal notes: Horse meat and offal: 28 days. Do not use in animals producing milk for human consumption.
Incorporating:
Presentation
White, finely grained free flowing 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:
1Acute, 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.
2Acute, sub-acute and chronic respiratory allergies.
3Chronic Obstructive Pulmonary Disease (COPD) in horses.In cases complicated by the presence of micro-organisms the simultaneous use of antimicrobial agents is indicated.
Dosage and administration
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).
Contra-indications, warnings, etc
Do not use in horses with known cardiac disease.
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.
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
Meat and offal: 28 days
Do not use in animals producing milk for human consumption.
Pharmaceutical precautions
Shelf life of the medicinal product as packaged for sale : 3 years.
Do not store above 30°C. Protect from light. Discard unused material. Add to feed immediately before administration. Discard remaining medicated feed.
Keep out of the reach and sight of children. For animal treatment only.
To be supplied only on veterinary prescription.
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-V
Legal category description:CD(Sch 4 Pt 2)
Packaging quantities
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.
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 08327/4308
Significant changes
GTIN
GTIN description:Ventipulmin Granules 16 micrograms/gram
GTIN:5012917086676