Introvit

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

vitamin A, vitamin D3, vitamin E, vitamin B1, vitamin B2, vitamin B6, vitamin B12, D-panthenol, nicotinamide, folic acid, biotin, choline chloride, DL-methionine, L-lysine hydrochloride

Available from:

Interchemie werken 'De Adelaar' B.V.

INN (International Name):

vitamin A, vitamin D3, vitamin E, vitamin B1, vitamin B2, vitamin B6, vitamin B12, D-panthenol, nicotinamide, folic acid, biotin

Dosage:

15000IU/ml+7500IU+20mg/ml+10mg/ml+5mg/mg+3mg/ml+60mcg/ml+25mg/ml+50mg/ml+150mcg/ml+125mcg/ml+12,5mg/ml+5mg/ml+7mg/ml

Pharmaceutical form:

solution for injection

Prescription type:

Prescription

Patient Information leaflet

NAME
AND
ADDRESS
OF
THE
MARKETING
AUTHORISATION
HOLDER
AND
OF
THE
MANUFACTURING
AUTHORISATION
HOLDER
RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT:
Marketing authorisation holder:
Manufacturer and batch releaser:
Interchemie werken “De Adelaar” B.V.
Interchemie werken “De Adelaar” Eesti AS
Metaalweg 8
Vanapere tee 14
5804 CG Venray
Viimsi, Harju county
The Netherlands
Estonia
NAME PRODUCT: Introvit.
PHARMACEUTICAL FORM: Solution for parenteral administration.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S):
Each ml contains:
- ACTIVE SUBSTANCE:
Vitamin A, retinol palmitate
15 000 IU.
Vitamin D
3
, cholecalciferol
7 500 IU.
Vitamin E,
-tocopherol acetate
20 mg.
Vitamin B
1
, thiamine hydrochloride
10 mg.
Vitamin B
2
, riboflavin sodium phosphate
5 mg.
Vitamin B
6
, pyridoxine hydrochloride
3 mg.
Vitamin B
12
, cyanocobalamin
60 µg.
D-panthenol
25 mg.
Nicotinamide
50 mg.
Folic acid
150 µg.
Biotin
125 µg.
Choline chloride
12.5 mg.
DL-methionine
5 mg.
L-lysine hydrochloride
7 mg.
- EXCIPIENTS:
Benzyl alcohol
21 mg.
INDICATIONS:
Vitamins are essential for the proper operation of many physiological
functions.
Introvit solution for parenteral administration is a well balanced
combination of essential vitamins and amino acids for cattle,
goats, sheep and swine. Introvit is indicated for:
- Prevention or treatment of vitamin or amino acid deficiencies.
- Prevention or treatment of stress (caused by vaccination, diseases,
transport, high humidity, high temperatures or extreme
temperature changes).
- Improvement of feed conversion.
CONTRA-INDICATIONS: Administration to calves, horses, foals, kids and
lambs.
TARGET SPECIES: Cattle, goats, sheep and swine.
ADVERSE REACTIONS:
No undesirable effects are to be expected when the prescribed dosage
regimen is followed. Hypersensitivity reactions may
occur. An overdose with vitamin A can result in decreased food
consumption, decreased body weight gain, erythema, alopecia,
mucosal changes, and long bone fractures, as indicated by limping or
an altered gait. An o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME:
INTROVIT
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS
CONTENT
SPECIFICATION
Retinol A oil
(vitamin A )
15,000 IU/ml
Ph. Eur.
Cholecalciferol oil
(vitamin D
3
)
7,500 IU/ml
Ph. Eur.
α
-Tocopherol acetate
(vitamin E)
20.0 mg/ml
Ph. Eur.
Thiamine hydrochloride
10.0 mg/ml
Ph. Eur.
Riboflavin sodium phosphate
5.0 mg/ml
Ph. Eur.
Pyridoxine hydrochloride
3.0 mg/ml
Ph. Eur.
Cyanocobalamin
60
μ
g/ml
Ph. Eur.
Dexpanthenol
25.0 mg/ml
Ph. Eur.
Nicotinamide
50.0 mg/ml
Ph. Eur.
Folic acid
150.0
μ
g/ml
Ph. Eur.
Biotin
125.0
μ
g/ml
Ph. Eur.
Choline chloride
12.5 mg/ml
Manufacturer’s specifications
DL-Methionine
5.0 mg/ml
Ph. Eur.
Lysine hydrochloride
7.0 mg/ml
Ph. Eur.
OTHER INGREDIENTS
CONTENT
SPECIFICATION
Benzyl alcohol
0.02 ml/ml
(21 mg/ml)
Ph. Eur.
Sodium citrate
5.0 mg/ml
Ph. Eur.
Polysorbate 80
137.5 mg/ml
Manufacturer’s specifications
Sodium hydroxide
ad pH = 4.5
Manufacturer’s specifications
Water for injections
ad 1 ml
Ph. Eur.
3.
PHARMACEUTICAL FORM
A solution for intramuscular or subcutaneous administration.
4.
PHARMACOLOGICAL PROPERTIES
VITAMIN A is involved in the process of formation and preservation of
function of epithelial
tissues and mucous membranes, is important for fertility and is
essential for vision.
VITAMIN D
3
regulates and corrects calcium and phosphate metabolism in blood and
plays an
important role in the uptake of calcium and phosphate from the
intestines. Especially in
young, growing animals vitamin D
3
is essential for the normal development of skeleton and
teeth.
VITAMIN E is as a fat-soluble intracellular antioxidant, involved in
stabilising unsaturated fatty
acids, thereby preventing toxic lipo-peroxides formation. Furthermore,
vitamin E protects the
oxygen-sensitive vitamin A from oxidative destruction in this
preparation.
B VITAMINS are essential for the proper operation of several
physiological functions.
5.
CLINICAL PARTICULARS
5.0
Target species: cattle, goats, sheep and swine.
5.1
Indications.
Vitamin A, B, D
3
and E