BROMENHYL® (solution for oral administration)

Oily liquid from colourless to pale yellow.

1 ml of the product contains active substances:

- bromhexine hydrochloride – 20,0 mg;

- menthol – 8,0 mg.

Excipients: benzyl alcohol, butyl alcohol, phosphoric acid, propylene glycol

ATCvet code: QR05 – cough and cold preparations; QR05CB – mucolytics.

BROMENHYL is a combination veterinary medicinal product containing menthol and bromhexine hydrochloride. Menthol regulates vascular permeability and tone and promotes reflex vasodilation in the vessels of the heart, brain and lungs, stimulates the respiratory centre, has analgesic and mild antiseptic action, increases appetite, increases salivation and intestinal peristalsis and stimulates the secretion of digestive glands.

Bromhexine has mucolytic (secretolytic) and expectorant effects. The mucolytic effect is associated with depolymerization and liquefaction of mucoprotein and mucopolysaccharide filaments, which improves mucus clearance and facilitates breathing. One of the important features of bromhexine action is its ability to stimulate the formation of surfactant — a surface-active substance of lipid-protein-mucopolysaccharide nature, which is synthesized in alveolar cells. Biosynthesis of surfactant is disrupted in respiratory diseases caused by Mycoplasma gallisepticum, Mycoplasma synoviae, Ornithobacterium rhinotracheale. This leads to disruption of alveolar cell stability, weakening of their response to adverse effects.

The combination of active substances of the product has mucolytic, expectorant actions, excretion of mucus and exudate from the trachea and nasal passages.

After oral administration of the product, bromhexine is rapidly absorbed from the digestive tract and within the first 24-48 hours bromhexine accumulates in lung tissues and on the bronchial mucosa. Its maximum concentration in blood plasma is observed 2-3 hours after oral administration. Bromhexine crosses the blood-brain and placental barriers. The peak of therapeutic efficacy occurs on days 3-5 — mucus is maximally liquefied and begins to be actively eliminated. Bromhexine is a lipophilic substance, it accumulates in lung tissues in concentrations that are 2-4 times higher than the concentration in blood plasma. With oral administration of bromhexine at a dose of 0,45 mg/kg body weight, the average maximum concentration in plasma is approximately 6–10 ng/ml. The time to maximum concentration (Tmax) is usually 1,8–4 hours after oral administration with drinking water. Bromhexine binds to plasma proteins (up to 99%), which ensures prolonged circulation of its metabolites. In the liver, bromhexine undergoes demethylation and oxidation, converting into an active metabolite — ambroxol. It is ambroxol that provides a significant part of the therapeutic effect. Bromhexine is excreted mainly by the kidneys with urine in the form of metabolites. A small part can be excreted with feces.

Menthol acts as an antiseptic, anaesthetic and secretion stimulator. After oral administration of the product, menthol is rapidly absorbed. Owing to its volatility, part of the menthol acts directly on the mucous membranes of the upper respiratory tract during swallowing. Menthol is distributed systemically, but its main action is directed at receptors of mucous membranes, causing a sensation of coolness and reflex bronchodilation. It is metabolized in the liver by binding with glucuronic acid and is excreted by the kidneys in the form of glucuronides and partially through the respiratory tract, providing an additional inhalation effect.

In complex therapy for treatment of domestic poultry (broilers and replacement pullets) for respiratory diseases of various etiology, which are accompanied by increased mucus secretion, difficult breathing.

- 1 ml of the product per 8 litres of drinking water or 2,5 ml of the product per 100 kg body weight per day, which corresponds to 0,45 mg bromhexine and 0,2 mg menthol per 1 kg body weight per day for 3-10 days.

Formula for calculating the volume of product V (in ml) for the quantity of drinking water consumed by poultry per day:

0,025 – coefficient of daily dose (2,5 ml of the product per 100 kg body weight);

M – average body weight of one bird, kg;

N – number of birds.

If necessary, in cases of acute disease and in severe disease courses (chronic respiratory diseases, infectious bronchitis, laryngotracheitis, etc.) or when the standard dose does not give the expected improvement during the first days of treatment, or when the disease is accompanied by significant accumulation of thick, viscous mucus that makes breathing difficult, the dose of the product may be doubled. The decision to increase dose must always be taken by a veterinarian based on clinical examination and severity of symptoms in the poultry flock.

Working solution should be prepared in a ratio of 1:40 (1 part of the product is added to 40 parts of warm drinking water), mixing. The working solution is immediately added to the required volume of drinking water according to water-supply standards for respective age categories of poultry.

During the treatment period, poultry must receive the medicated drinking water as the only source of drinking water.

A fresh medicated solution must be prepared every 24 hours.

Do not use in poultry with hypersensitivity to the components of the product.

Do not administer concomitantly with codeine-containing products or alkaline solutions.

Do not use in cases of pulmonary oedema.

Do not use in laying birds producing eggs for human consumption.

No side effects have been observed when the product is used at the recommended dose.

In individual animals, dyspeptic disorders, increased coughing or bronchospasm may occur.

The product can be used together with antibiotics and/or sulfonamides and bronchodilators. Bromhexine alters the distribution of certain antibiotics in the body and increases their concentrations in serum and nasal secretions (e.g., spiramycin, tylosin, oxytetracycline). The product is incompatible with codeine products, alkaline solutions.

Meat: 0 days.

Bottles of neutral glass (types NS-1, NS-2, USP-1) closed with rubber stoppers and sealed with aluminium caps, with volumes of 10, 20, 50 and 100 ml.

Plastic containers (canisters) of 1 and 5 litres.

Store in a dry, dark place out of the sight and reach of children, at a temperature between 5 and 25 °C.

2 years.