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Date: Sunday, April 14, 2024 8:20

Release 5.96
Ventipulmin Syrup 25 micrograms/ml
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Cardiovascular and respiratory preparations
Active ingredient: Clenbuterol
Product:Ventipulmin® Syrup 25 micrograms/ml
Product index: Ventipulmin Syrup
Withdrawal notes: Horse meat and offal: 28 days. Do not use in animals producing milk for human consumption.
Incorporating:
Presentation
Clear colourless syrup. Each ml contains 25 micrograms clenbuterol hydrochloride as active substance plus 1.8 mg methyl parahydroxybenzoate and 0.2 mg propyl parahydroxybenzoate as excipients.
Uses
Treatment of respiratory disease in horses where it is considered that 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 respiratory allergies.
2Acute, 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.
3Chronic Obstructive Pulmonary Disease (COPD).
In cases complicated by bacterial infection, the administration of antimicrobial agents is recommended.
Dosage and administration
For oral use. Administer 4 ml Ventipulmin Syrup per 125 kg bodyweight twice daily.
This is equivalent to twice daily administration of 0.8 micrograms clenbuterol hydrochloride per 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
Do not use in cases of known hypersensitivity to the active ingredient. Do not use in horses with known cardiac disease.
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.
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.
If used during pregnancy, treatment must be discontinued at the expected time of delivery since uterine contractions may be abolished under its influence.
Ventipulmin antagonises the effects of prostaglandin F2α and oxytocin. Ventipulmin is antagonised by β-adrenergic blocking agents.
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 : 2 years.
Shelf life after first opening the immediate packaging : 30 days.
Do not store above 25°C. Protect from light.
Keep out of the reach and sight of children. For animal treatment only.
To be supplied only on veterinary prescription. Keep the bottle in outer carton.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product 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
355ml screw top polyethylene bottle with a 4ml pump dispenser.
Further information
Pharmacotherapeutic group: Adrenergics for systemic use (selective beta2-adrenoreceptor agonists)
ATC Vet code : QR03CC13: Drugs for obstructive airway disease.
Pharmacodynamic properties
Ventipulmin contains clenbuterol hydrochloride, which is a sympathomimetic amine which preferentially binds to β2 adrenoreceptors on cell membranes of the bronchi. This subsequently activates the enzyme adenylate cyclase in smooth muscle cells, thus providing intense bronchodilating properties and decreasing airway resistance with minimum effect on the cardiovascular system. Ventipulmin has been shown to inhibit histamine release from mast cells in the lungs, and enhance mucociliary clearance in horses.
Pharmacokinetic particulars
After oral administration in horses, clenbuterol is readily absorbed and maximum plasma concentrations reached within 2 hours of dosing. Steady state level in plasma is reached after 3-5 days treatment and range from 1.0 – 2.2 ng/ml.
The substance is rapidly distributed in tissues and metabolised primarily by the liver. Clenbuterol is the main excretory product and approximately 45% of the dose is eliminated unchanged in the urine. The kidneys excrete 70 – 91% of the total dose, and the remainder is eliminated in the faeces (6 – 15%).
Marketing Authorisation Number
Vm 08327/4310
Significant changes
GTIN
GTIN description:Ventipulmin Syrup 25 micrograms/ml
GTIN:5012917086423