Bisolvon 3 mg/ml solution for injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
bromhexine hydrochloride
Available from:
Boehringer Ingelheim Ltd
ATC code:
QR05CB02
Dosage:
3 Mg/Ml
Pharmaceutical form:
Solution for Injection
Therapeutic group:
Bovine Porcine
Therapeutic area:
Respiratory Tract Preparations
Authorization status:
Authorised
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bisolvon 3mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear colourless sterile aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As an aid to the treatment of respiratory disease in cattle and pigs, 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
Active substance
Bromhexine Hydrochloride
3.0 mg
Excipients
Methyl Parahydroxybenzoate
0.7 mg
Propyl Parahydroxybenzoate
0.3 mg
Water for Injections
to
1.0 ml
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/03/2014_
_CRN 7016525_
_page number: 1_
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
Care should be taken to avoid accidental self injection.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
The product may be given to pregnant and lactating animals.
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
Bisolvon injection should be administered once daily by intramuscular route.
SPECIES
DOSE OF
DOSE OF BISOLVON
FREQUENCY
DURATION OF
BROMHEXINE
INJECTION
TREATMENT
HYDROCHLORIDE
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