MULTI-12K1 PEDIATRIC

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ASCORBIC ACID; BIOTIN; COLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NICOTINAMIDE; PHYTOMENADIONE; PYRIDOXINE (VIT B6) HYDROCHLORIDE; RIBOFLAVINE; THIAMINE (VIT B1) HYDROCHLORIDE; TOCOPHEROL (VIT E) (AS TOCOPHERYL ACETATE); VITAMIN A PALMITATE

Available from:

TEVA MEDICAL MARKETING LTD.

ATC code:

A11AA03

Pharmaceutical form:

SUPPLEMENT FOR SOLUTION FOR INFUSION

Composition:

ASCORBIC ACID 80 MG / 4 ML; VITAMIN A PALMITATE 2300 IU / 4 ML; COLECALCIFEROL 400 IU / 4 ML; THIAMINE (VIT B1) HYDROCHLORIDE 1.2 MG / 4 ML; RIBOFLAVINE 1.4 MG / 4 ML; NICOTINAMIDE 17 MG / 4 ML; PYRIDOXINE (VIT B6) HYDROCHLORIDE 1 MG / 4 ML; DEXPANTHENOL 5 MG / 4 ML; TOCOPHEROL (VIT E) (AS TOCOPHERYL ACETATE) 7 IU / 4 ML; PHYTOMENADIONE 0.2 MG / 4 ML; FOLIC ACID 140 MCG/ML; BIOTIN 20 MCG/ML; CYANOCOBALAMIN 1 MCG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

SANDOZ CANADA INC., CANADA

Therapeutic group:

MULTIVITAMINS AND OTHER MINERALS, INCL. COMBINATIONS

Therapeutic area:

MULTIVITAMINS AND OTHER MINERALS, INCL. COMBINATIONS

Therapeutic indications:

For use as a multiple vitamin supplement for infants and children up to 11 years of age. It is also indicated in other situations where there are increased requirements for vitamins due to stress situations such as surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states. The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. The use of a multivitamin product obviates the need to speculate on the status of individual vitamin nutriture.

Authorization date:

2013-08-31

Summary of Product characteristics

MULTI-12 K
1
PEDIATRIC , 03/10/2018 AH
לע רשואו קדבנ הז ןולע
-
ךיראתב תואירבה דרשמ ידי
ילוי
2003
PHYSICIANS’ PRESCRIBING INFORMATION
MULTI-12/K
1 PEDIATRIC
Multiple Vitamins for Infusion
MULTI-12/K
1 PEDIATRIC
is a multiple vitamin supplement containing the following vitamins:
VIAL 1
Ascorbic acid
80 mg
Vitamin A
2300 IU
Vitamin D
400 IU
Thiamine (as hydrochloride)
1.2 mg
Riboflavin (as phosphate)
1.4 mg
Pyridoxine hydrochloride
1 mg
Niacinamide
17 mg
_d_
-Panthenol
5 mg
Vitamin E (
_dl_
-alpha tocopheryl acetate)
7 IU
Vitamin K
1
0.2 mg
Also contains: polysorbate 80, 1.25%, sodium hydroxide and/or
hydrochloric acid to adjust pH and water for injection.
VIAL 2
Biotin
20 mcg
Folic Acid
140 mcg
Vitamin B
12
(cyanocobalamin)
1 mcg
Also contains: mannitol 7.5 %, sodium citrate and/or citric acid to
adjust pH and water for injection.
INDICATIONS
MULTI-12/K
1 PEDIATRIC
is indicated for use as a multiple vitamin supplement for infants and
children up
to 11 years of age.
Its administration helps to maintain plasma vitamin levels and helps
to prevent depletion of endogenous
stores of the vitamins and development of subsequent deficiency
symptoms.
It is also indicated in other situations where there are increased
requirements for vitamins due to stress
situations such as surgery, extensive burns, fractures and other
trauma, severe infectious diseases, and
comatose states.
The physician should not await the development of clinical signs of
vitamin deficiency before initiating
vitamin therapy. The use of a multivitamin product obviates the need
to speculate on the status of
individual vitamin nutriture.
MULTI-12/K
1
PEDIATRIC
,
through
the
intake
of
these
necessary
vitamins,
contributes
towards
the
maintenance of the body's normal resistance and repair processes.
MULTI-12 K
1
PEDIATRIC , 03/10/2018 AH
2
CONTRAINDICATIONS
Known hypersensitivity to any of the vitamins in this product or a
pre-existing hypervitaminosis.
MULTI-12 K
1
PEDIATRIC , 03/10/2018 AH
3
PRECAUTIONS
GENERAL: UNLI