Bisolvon 3 mg/ml Solution for Injection

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Bromhexine Hydrochloride

Commercializzato da:

Boehringer Ingelheim Ltd

Codice ATC:

QR05CB02

INN (Nome Internazionale):

Bromhexine Hydrochloride

Stato dell'autorizzazione:

Expired

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bisolvon 3 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Bromhexine hydrochloride 3.0 mg
Preservatives:
Methyl Parahydroxybenzoate 0.7 mg
Propyl Parahydroxybenzoate 0.3 mg
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for injection.
Clear colourless 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
None known.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known
4.5
SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None known.
(II) 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
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
Bisolvon Injection should only be administered by intramuscular route.
SPECIES
DOSE OF
BROMHEXINE
HYDROCHLORIDE
DOSE OF BISOLVON
INJECTION
FREQUENCY
DURATION OF
TREATMENT
CATTLE
0.5 mg/kg
17ml / 100kg
once daily
5 days
PIGS
0.2-0.5 mg/kg
7-17ml / 100kg
once daily
5 days
Maximum dose at one site : 20ml cattle, 10ml pigs.
4.10
OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)
Bisolvon Injection has a good margin of safety.
4.11 WITHDRAWAL PERIOD(S)
Meat and Offal : Cattle and Pigs : 28 days
Not permitted for use in cows producing milk for human consumption
5. PHARMACOLOGICAL PROPERTIES
ATCVET CODE : QR05CB02
SUMMARY PRESENTATION OF THE ACTIVE INGREDIENT:
Bisolvon is a mucolytic with two main pharmaco