TUDOMAX, 10 mg/g, powder for use in drinking water/milk

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Bromhexine
Available from:
SP Veterinaria, S.A.
ATC code:
QR05CB02
INN (International Name):
Bromhexine
Dosage:
10 milligram(s)/gram
Pharmaceutical form:
Oral powder
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Cattle, Chickens, Ducks, Pigs, Turkeys
Therapeutic area:
bromhexine
Therapeutic indications:
Mucolytic
Authorization status:
Authorised
Authorization number:
VPA10790/011/001
Authorization date:
2017-02-10

Read the complete document

Health Products Regulatory Authority

04 December 2018

CRN000YRH

Page 1 of 6

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

TUDOMAX, 10 mg/g, powder for use in drinking water/milk

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each g contains

Active substance:

Bromhexine

10.00 mg​

(As bromhexine hydrochloride

​10.98 mg)

Excipients:

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Powder for use in drinking water/milk

White or cream coloured powder

4 CLINICAL PARTICULARS

4.1 Target Species

Cattle (Calves), pigs, chickens, turkeys and ducks

4.2 Indications for use, specifying the target species

Mucolytic treatment of congested respiratory tract.

4.3 Contraindications

Do not use in case of pulmonary oedema.

In case of serious lungworm infection, the drug should only be used 3 days after the

commencement of the anthelmintic treatment.

Do not use in case of hypersensitivity to the active substance or to any of the

excipients.

See section 4.11

4.4 Special warnings for each target species

None.

Health Products Regulatory Authority

04 December 2018

CRN000YRH

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4.5 Special precautions for use

Special precautions to be taken by the person administering the veterinary medicinal

product to animals

This product may cause hypersensitivity reactions (allergy). People with known

hypersensitivity to bromhexine or lactose should avoid contact with the product.

During preparation and administration inhalation of dust particles should be avoided.

Wear an appropriate dust mask (either a disposable half-mask respirator conforming

to European Standard EN149 or a non-disposable respirator to European Standard

EN 140 with a filter to EN 143), when handling the product. If respiratory symptoms

develop following exposure, seek medical advice and show this warning to the

physician.

This product may cause irritation to the skin, eyes and mucous membranes. Avoid

direct contact with the product. Wear gloves and protective glasses during the use of

the product. Wash hands and any exposed skin after use. If accidental contact occurs,

rinse the affected area with large amounts of clean water.

Do not eat, drink or smoke while handling this product.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Studies in laboratory animals have not produced evidence of foetotoxic effects or

effects on fertility at the recommended dose. However this has not been specifically

studied in the target species. Use only according to the benefit-risk assessment of

the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interactions

The product may be used in conjunction with antibiotics and/or sulphonamides and

bronchodilators.

When administered simultaneously with some antibiotics (e.g. oxytetracycline,

spiramycin and tylosin), bromhexine has been shown to increase their concentration

in the serum and in the nasal secretions. However, the significance of this finding is

uncertain.

4.9 Amounts to be administered and administration route

For oral administration.

Health Products Regulatory Authority

04 December 2018

CRN000YRH

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0.45 mg of bromhexine per kg bodyweight, equivalent to 0.45 g of powder per 10 kg

bodyweight, administered daily for 3 to 10 days, in drinking water, milk or liquid feed.

The following formula may be used to calculate the required concentration of

product (in milligrams of product per litre drinking water):

In order to obtain the correct dosage the concentration of bromhexine has to be

adjusted accordingly. The required amount of product should be weighed as

accurately as possible using suitably calibrated weighing equipment. The intake of

medicated water, milk and liquid feed depends on the clinical condition of the

animals.

When administering in liquid feed, first dissolve the product in water and then add

feed. The preparation should be used immediately. Care should be taken that the

intended dose will be completely ingested.

Any unused medicated water should be discarded after 24 hours.

The solubility of the product has been tested at the maximum concentration of 45

g/L at 20° C and at 5° C, a fine suspension may be observed.

Milk should be heated to feeding temperature prior to addition of the powder. The

medicated milk should be freshly prepared prior to use and used within 3 hours.

FOR PROPORTIONER:

When using a water proportioner, adjust the pump between 1 % to 5 % and adapt

the volume of preparation accordingly.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Unknown.

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04 December 2018

CRN000YRH

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4.11 Withdrawal period(s)

Cattle (calves)

Meat and offal: 2 days

Not authorised for use in animals producing milk for human consumption.

Pigs

Meat and offal: Zero days.

Chickens, turkeys and ducks

Meat and offal: Zero days

Do not use in birds producing eggs for consumption, during and 4 weeks before the

laying phase.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Expectorants except combinations with cough

suppressants, mucolytics.

ATCvet code: QR05CB02.

5.1 Pharmacodynamic properties

Bromhexine is a mucoregulator. By activating the secretion of the seromucous glands,

bromhexine helps to re-establish the viscosity and elasticity of bronchial secretions in

the tracheobronchial tree. In addition, its expectorant action encourages mobilisation

of mucus and enables effective bronchial drainage, thereby improving the

functioning and defence capability of the lung.

These two simultaneous actions lead to an abundant discharge and facilitate a

productive cough.

It breaks down the network of acid glycoprotein fibres found in mucoid sputum,

which are mainly responsible for the characteristic viscosity.

5.2 Pharmacokinetic particulars

Absorption

In pigs, bromhexine is rapidly absorbed after oral administration; peak plasma

concentration occurs within one to three hours.

The concentration plateau is reached 12 hours after the second or third

administration.

In calves, the plasma concentrations gradually increase over several hours after

administration.

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04 December 2018

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In turkeys or broilers, the peak plasma concentrations are achieved within 2 - 4 hours

after oral administration of bromhexine..

Distribution

Due to the lipophilic character of bromhexine, the parent compound has a strong

affinity for lipid tissues and a slow depletion profile from these tissues.

Metabolism

Bromhexine is extensively metabolised to more polar compounds.

Elimination

The apparent half-life of elimination of total plasma radioactivity after the last dose is

20 to 30 hours in pigs, 40 to 50 hours in calves and 40 to 50 hours in chickens and

turkeys.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Citric acid, anhydrous

Silica, colloidal anhydrous

Lactose monohydrate

6.2 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be

mixed with other veterinary medicinal products.

6.3 Shelf-life

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

Shelf life after first opening the immediate packaging: 3 months

Shelf life after dilution in water according to directions: 24 hours.

Shelf life after dilution in milk according to directions: 3 hours.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special temperature storage

conditions.

Keep the bags tightly closed.

Health Products Regulatory Authority

04 December 2018

CRN000YRH

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6.5 Nature and composition of immediate packaging

Polyethylene/aluminium/polypropylene thermosealed bags of 1 kg and 500 g

6.6 Special precautions for the disposal of unused veterinary medicinal

products or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such

veterinary medicinal product should be disposed of in accordance with local

requirements.

7 MARKETING AUTHORISATION HOLDER

SP Veterinaria, S.A.

Ctra. Reus - Vinyols Km 4, 1

Riudoms 43330

Spain

8 MARKETING AUTHORISATION NUMBER(S)

VPA10790/011/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 10

February 2017

10 DATE OF REVISION OF THE TEXT

December 2018

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