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

Land: Verenigd Koninkrijk

Taal: Engels

Bron: VMD (Veterinary Medicines Directorate)

Werkstoffen:

Bromhexine Hydrochloride

Beschikbaar vanaf:

Ceva Animal Health Ltd

ATC-code:

QR05CB02

INN (Algemene Internationale Benaming):

Bromhexine Hydrochloride

farmaceutische vorm:

Powder for use in drinking water

Prescription-type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutische categorie:

Cattle, Chickens, Duck, Pigs, Turkeys

Therapeutisch gebied:

Respiratory mucolytic

Autorisatie-status:

Expired

Autorisatie datum:

2015-10-07

Productkenmerken

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