BISOLVON 10 MG/G ORAL POWDER
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
22-12-2015
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Active ingredient:
BROMHEXINE HYDROCHLORIDE
Available from:
Boehringer Ingelheim Ltd
ATC code:
QR05CB02
INN (International Name):
BROMHEXINE HYDROCHLORIDE
Dosage:
10 mg/g
Pharmaceutical form:
Oral Powder
Prescription type:
POM
Therapeutic group:
Bovine, Canine, Feline, Porcine
Therapeutic area:
Bromhexine
Therapeutic indications:
Respiratory Tract Preparations
Authorization status:
Authorised
Authorization date:
1991-10-01
Summary of Product characteristics
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.
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 07/12/2015_
_CRN 7022423_
_page number: 1_
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 INTERACTION
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 drinki
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