Bisolvon 10 mg/g Oral Powder

Kraj: Wielka Brytania

Język: angielski

Źródło: VMD (Veterinary Medicines Directorate)

Składnik aktywny:

Bromhexine Hydrochloride

Dostępny od:

Boehringer Ingelheim Limited

Kod ATC:

QR05CB02

INN (International Nazwa):

Bromhexine Hydrochloride

Forma farmaceutyczna:

Oral powder

Typ recepty:

POM-V - Prescription Only Medicine – Veterinarian

Grupa terapeutyczna:

Cats, Cattle, Dogs, Pigs

Dziedzina terapeutyczna:

Respiratory mucolytic

Status autoryzacji:

Authorized

Data autoryzacji:

2004-04-08

Charakterystyka produktu

Revised: April 2018
AN: 02154/2017
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
10 mg Bromhexine hydrochloride per gram
For a full list of excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Oral powder.
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
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
Page 1 of 5
Revised: April 2018
AN: 02154/2017
Avoid contact with 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
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.
SPECIES
TOTAL DAILY
DOSE OF
BROMHEXINE
HYDROCHLORI
DE
(MG /KG)
TOTAL DAILY
DOSE IN G OF
POWDER
FREQUENCY
DURATION OF
TREATMENT
(DAYS)
Cattle
0.5
5 g/100 kg
Once daily
5
Pigs
0.2-0.5
2-5g/100 kg
Once daily
5
Dogs
2.0
2g/10 kg
Twice daily
5
Cats
1.0
0.5g/5 kg
Once daily
7
The 500 g and 1 kg pack contains a white measure, delivering
approximately 5
g when filled level. The sachet pack contains blue measuring scoops
delivering approximate