Bisolvon 10mg/g Oral Powder

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

Bromhexine hydrochloride

Available from:

Boehringer Ingelheim Ltd

ATC code:

QR05CB02

INN (International Name):

Bromhexine hydrochloride

Dosage:

10 milligram(s)/gram

Pharmaceutical form:

Oral powder

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Cattle, Dogs, Pigs

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.
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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
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