Exflow 10 mg/g Powder for Use in Drinking Water for Cattle (Calves), Pigs, Chickens, Turkeys and Ducks

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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Active ingredient:

Bromhexine Hydrochloride

Available from:

Ceva Animal Health Ltd

ATC code:

QR05CB02

INN (International Name):

Bromhexine Hydrochloride

Pharmaceutical form:

Powder for use in drinking water

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Chickens, Duck, Pigs, Turkeys

Therapeutic area:

Respiratory mucolytic

Authorization status:

Expired

Authorization date:

2015-10-07

Summary of Product characteristics

                                Revised: September 2022
AN: 01504/2022
Page 1 of 6
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Exflow 10 mg/g powder for use in drinking water for cattle (calves),
pigs, chickens,
turkeys and ducks
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Bromhexine................................................ 9.11 mg
(as bromhexine hydrochloride
10.00 mg)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for use in drinking water
White to slightly beige 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.
Revised: September 2022
AN: 01504/2022
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
In case of serious lungworm infection, the drug should only be used 3
days after the
commencement of the anthelmintic treatment.
In case of primary and/or secondary infection, the combination with
antibiotics should
be considered. When administered concomitantly with the product,
antimicrobial
agents should not be underdosed.
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 any of the excipients should avoid
contact with the
product.
This product may cause irritation to the skin, eyes and mucous
membranes.
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
                                
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