Ketol 80% w/v Oral Solution

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Propylene Glycol

Available from:

Intervet UK Ltd

ATC code:

QA16QA01

INN (International Name):

Propylene Glycol

Authorization status:

Expired

Summary of Product characteristics

REVISED 03 SEPTEMBER 2008
AN: 02496/2007
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE V ETERINARY MEDICINAL PRODUCT
Ketol 80% w/v oral solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Qualitative composition
quantitative composition % w/v
Propylene glycol
80
Excipient(s)
Amaranth (E123)
0.00016
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Oral solution.
A pink, clear aqueous solution.
4
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and sheep
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As an aid to the treatment of acetonemia in cattle and pregnancy
toxemia in
sheep.
4.3
CONTRA-INDICATIONS
Not to be used in cases of known hypersensitivity to the active
ingredient.
4.4
SPECIAL WARNING FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
(I)
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
For oral administration only.
REVISED 03 SEPTEMBER 2008
AN: 02496/2007
(II)
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL PRODUCT TO THE ANIMALS
In case of accidental eye contact, wash eyes with plenty of clean
water.
If irritation occurs, seek medical attention. In case of contact with
skin, remove
any contaminated clothing and wash affected area thoroughly with soap
and
water. If irritation occurs seek medical advice.
Ingestion: If accidentally swallowed seek medical advice. Wash hands
after
use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7
USE DURING PREGNANCY OR LACTATION
The product may be used in lactating cattle and pregnant sheep.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
The product may be administered in the drinking water, as a drench, or
on the
feed.
Cattle
First day 225 ml (8 fl.oz.) morning and evening. Next
three days 115 ml (4 fl.oz.) morning and evening.
Sheep
115 ml (4 fl.oz.) daily for several days.
4.10 OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF
NECESSARY
No particular effects.
4.11 WITHDRAWAL