Vitesel Emulsion for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Alpha Tocopheryl Acetate, Selenium

Available from:

Norbrook Laboratories Limited

ATC code:

QA11JB

INN (International Name):

Alpha Tocopheryl Acetate, Selenium

Pharmaceutical form:

Emulsion for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs, Sheep

Therapeutic area:

Vitamin; Mineral

Authorization status:

Expired

Authorization date:

1993-06-18

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vitesel Emulsion for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Alpha-Tocopheryl Acetate
68 mg/ml
Selenium (as Potassium Selenate)
1.5 mg/ml
EXCIPIENTS:
Benzyl alcohol as antimicrobial preservative
20 mg/ml
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Emulsion for Injection.
A white emulsion free from visable particles.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Ewes
Piglets
Lambs (new born and older lambs)
Calves
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated for the prevention and treatment of Vitamin E/selenium
deficiency
syndrome in piglets, lambs and calves, including the various
manifestations of
nutritional muscular dystrophy (white muscle disease). Administration
to the
pregnant ewe may assist in the prevention of the deficiency syndrome
in the
new born lamb under similar conditions.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Hypersensitivity
reactions,
particularly
in
cattle,
have
occasionally
been
reported following use of this product. In such an event, symptomatic
treatment should be undertaken as appropriate.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Observe aseptic precautions.
Shake vial before use.
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)
Injection site reactions may occur in some animals. These are usually
of a
transient nature and diminish after a few days.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Can be safely administered to pregnant and lactating sheep.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Administer by intramuscular injection only to piglets and calves.
Piglets:
1 ml per 25 kg bodyweight
Repeat after 2-4 weeks