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

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Bromhexine

Διαθέσιμο από:

SP Veterinaria, S.A.

Φαρμακολογική κατηγορία (ATC):

QR05CB02

INN (Διεθνής Όνομα):

Bromhexine

Δοσολογία:

10 milligram(s)/gram

Φαρμακοτεχνική μορφή:

Oral powder

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Cattle, Chickens, Ducks, Pigs, Turkeys

Θεραπευτική περιοχή:

bromhexine

Θεραπευτικές ενδείξεις:

Mucolytic

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2017-02-10

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
03 December 2021
CRN00CFS8
Page 1 of 4
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 cases of pulmonary oedema.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In case of serious lungworm infection, the product should only be used
3 days after the commencement of the anthelmintic
treatment.
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 to any of the
excipients should avoid contact with the product.
This product may cause irritation of the respiratory and
gastrointestinal tracts if accidentally ingested or inhaled.
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.
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.
Health Products Regulatory Authority