CERNEVIT

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ASCORBIC ACID; BIOTIN; COCARBOXYLASE TETRAHYDRATE; COLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE (VIT B6) HYDROCHLORIDE; RETINOL PALMITATE; RIBOFLAVINE; TOCOPHEROL

Available from:

REMEDIX CARE LTD

ATC code:

B05CB10

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

RETINOL PALMITATE 3500 IU/VIAL; COLECALCIFEROL 220 IU/VIAL; TOCOPHEROL 10.2 MG/VIAL; ASCORBIC ACID 125 MG/VIAL; RIBOFLAVINE 5.67 MG/VIAL; PYRIDOXINE (VIT B6) HYDROCHLORIDE 5.5 MG/VIAL; CYANOCOBALAMIN 0.006 MG/VIAL; FOLIC ACID 0.414 MG/VIAL; DEXPANTHENOL 16.15 MG/VIAL; BIOTIN 0.069 MG/VIAL; NICOTINAMIDE 46 MG/VIAL; COCARBOXYLASE TETRAHYDRATE 5.8 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BAXTER S.A., BELGIUM

Therapeutic area:

COMBINATIONS

Therapeutic indications:

Vitamin supplementation in patients receiving parenteral nutrition. Only for adults and children over 11 years of age.

Authorization date:

2023-11-30

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
CERNEVIT
1.
NAME OF THE MEDICINAL PRODUCT
Cernevit
Powder for solution for injection.
Intravenous administration.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains:
Retinol palmitate
3500 IU
Cholecalciferol
220 IU
DL-

-tocopherol
10.20 mg
Ascorbic acid
125 mg
Cocarboxylase tetrahydrate
5.80 mg
Riboflavin dihydrated sodium phosphate
5.67 mg
Pyridoxine hydrochloride
5.50 mg
Cyanocobalamin
6 µg
Folic acid
414 µg
Dexpanthenol
16.15 mg
Biotin
69 µg
Nicotinamide
46 mg
equivalent to:
Vitamin A (Retinol)
3500 IU
Vitamin D3
220 IU
Vitamin E (

tocopherol)
11.20 IU
Vitamin C
125 mg
Vitamin B1 (Thiamine)
3.51 mg
Vitamin B2 (Riboflavin)
4.14 mg
Vitamin B6 (pyridoxine)
4.53 mg
Vitamin B12
6 µg
Folic Acid
414 µg
Pantothenic acid
17.25 mg
Biotin
69 µg
Vitamin PP (Niacine)
46 mg
Excipient with known effect:
Each vial contains 112.5 mg soybean lecithin.
Each vial contains 24 mg sodium (main component of cooking/table
salt). This is
equivalent to 1.2% of the WHO recommended maximum daily intake of 2 g
sodium
for an adult.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
Orange yellow freeze-dried cake.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Vitamin supplementation in patients receiving parenteral nutrition.
Only for adults and children aged over 11 years of age.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
1 vial per day
Intravenous route exclusively.
_Method of Reconstitution: _
The single-dose vial of CERNEVIT is reconstituted by adding 5 ml of
Sterile Water
for Injection into the vial and gently mixing to dissolve the
lyophilized powder. The
obtained solution is yellow-orange in colour. The resultant solution
should be
administered by intravenous infusion. After reconstitution, CERNEVIT
should be
used immediately or stored under refrigeration (2-8

C) for no more than 24 hours. To
minimize vitamin losses in parenteral nutrition admixtures, add the
vitamins
immediat