Bisolvon 10mg/g Oral Powder

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Bromhexine hydrochloride

Dostępny od:

Boehringer Ingelheim Vetmedica GmbH

Kod ATC:

QR05CB02

INN (International Nazwa):

Bromhexine hydrochloride

Dawkowanie:

10 milligram(s)/gram

Forma farmaceutyczna:

Oral powder

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Dziedzina terapeutyczna:

bromhexine

Status autoryzacji:

Authorised

Data autoryzacji:

1991-10-01

Charakterystyka produktu

Health Products Regulatory Authority
23 November 2018
CRN008QMV
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bisolvon 10mg/g Oral Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
Active Substance
Bromhexine Hydrochloride 10 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution or addition to feed.
White crystalline powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs, dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As an aid to the treatment of respiratory disease in cattle, pigs,
dogs and cats where
mucus is a complicating factor.
4.3 CONTRAINDICATIONS
Not for use in cows producing milk for human consumption.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
Health Products Regulatory Authority
23 November 2018
CRN008QMV
Page 2 of 5
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Avoid contact with the skin and eyes. In case of accidental eye
contact, flush the
affected eye with copious amounts of clean running water. Wash hands
and exposed
skin after administering the product.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Not applicable.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
May be used in conjunction with antibiotics and/or sulphonamides,
bronchodilators
etc.
4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For oral administration in the feed or drinking water. Add to feed or
drinking water
immediately before administration. Discard any remaining medicated
feed or
drinking water.
SPECIES
TOTAL DAILY DOSE OF
BROMHEXIDINE
HYDROCHLORIDE (MG PER
KG)
TOTAL DAILY
DOSE IN G OF
POWDER
FREQUENCY
DURATION OF
TREATMENT (DAYS)
Cattle
0.5
5g / 100 kg
Once daily
5
Pigs
0.2-0.5
2-5 g / 100 kg
Once daily
5
Dogs
2.0
2 g / 10 kg
Twice daily
5
Cats
1.0
0