Vitenium Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

D Alpha Tocopheryl Acetate, Selenium

Available from:

Elanco Europe Ltd

ATC code:

QA11JB

INN (International Name):

D Alpha Tocopheryl Acetate, Selenium

Authorization status:

Expired

Summary of Product characteristics

Revised: September 2016
AN: 00629/2016
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vitenium Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients:
%w/v
dl-alpha-tocopheryl acetate
15.0
Selenium (as anhydrous sodium selenite)
0.05
Other ingredients:
Antimicrobial preservative:
Benzyl alcohol
0.73
Methyl hydroxybenzoate
0.18
Propyl hydroxybenzoate
0.09
Other excipients to volume
100.0
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Opalescent yellow aqueous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses, cattle and sheep.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Prophylactic indications
a
On farms in known selenium-deficient soil areas.
b
When diets low in vitamin E are fed, e.g. diets containing high levels
of
moist stored grain or maize silage.
Revised: September 2016
AN: 00629/2016
c
On farms where there is a history of vitamin E and/or selenium
deficiency,
as may be indicated by poor breeding performance, excessive transport
stress, or nutritional muscular dystrophy (in young animals on turning
out to
grass).
d
To provide extra vitamin E during periods of heavy work-load (horses).
Therapeutic indications
For the treatment of the various manifestations of nutritional
muscular
dystrophy (white muscle disease, nutritional myopathy) affecting
cardiac
and/or skeletal muscles, and associated symptoms.
4.3
CONTRAINDICATIONS
Do not overdose.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
See Section 4.7 for warnings regarding use in pregnant cattle.
Administer to horses by intramuscular injection only.
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Do not overdose.
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)
Anaphylactic type reactions have occasionally been reported following
use of
this