Cernevit powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nicotinamide; Biotin; Dexpanthenol; Folic acid; Cyanocobalamin; Pyridoxine hydrochloride; Thiamine; Riboflavin sodium phosphate; Ascorbic acid; Retinol; Colecalciferol; Alpha tocopherol

Available from:

Baxter Healthcare Ltd

ATC code:

B05XA31

INN (International Name):

Nicotinamide; Biotin; Dexpanthenol; Folic acid; Cyanocobalamin; Pyridoxine hydrochloride; Thiamine; Riboflavin sodium phosphate; Ascorbic acid; Retinol; Colecalciferol; Alpha tocopherol

Dosage:

46mg ; 69microgram ; 17.25mg ; 414microgram ; 6microgram ; 4.53mg ; 3.51mg ; 4.14mg ; 125mg ; 3500unit ; 220unit ; 11.2unit

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 09030000; GTIN: 5413760054025

Summary of Product characteristics

OBJECT 1
CERNEVIT
Summary of Product Characteristics Updated 26-Mar-2018 | Baxter
Healthcare Ltd
1. Name of the medicinal product
Cernevit
2. Qualitative and quantitative composition
Each vial of powder contains:
Retinol palmitate
3500 IU
Colecalciferol
220 IU
DL-α-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
D-Biotin
69 µg
Nicotinamide
46 mg
equivalent to:
Vitamin A (Retinol)
3500 IU
Vitamin D
3
220 IU
Vitamin E (α tocopherol)
11.20 IU
Vitamin C
125 mg
Vitamin B
1
(thiamine)
3.51 mg
Vitamin B
2
(riboflavin)
4.14 mg
Vitamin B
6
(pyridoxine)
4.53 mg
Vitamin B
12
6 µg
Folic Acid
414 µg
Pantothenic acid
17.25 mg
Biotin
69 µg
Vitamin PP (niacin)
46 mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection or infusion.
4. Clinical particulars
4.1 Therapeutic indications
Supply of vitamins corresponding to the daily needs of adults and
children over 11 years requiring multi-
vitamin supplementation by the parenteral route when oral nutrition is
contraindicated, impossible or
insufficient (e.g. due to malnutrition, gastrointestinal
malabsorption, parenteral nutrition, etc).
4.2 Posology and method of administration
DOSAGE
Adults and children aged over 11 years : 1 vial/day.
ADMINISTRATION
Method of reconstitution: see section 6.6, Instruction for use and
handling.
Intravenous route: By slow intravenous injection (at least 10 minutes)
or by infusion in a solution of 5%
glucose or 0.9% sodium chloride solution for infusion.
Cernevit may be included in the composition of nutritive mixtures
combining carbohydrates, lipids,
amino acids and electrolytes provided that compatibility and stability
have been confirmed for each
nutritive mixture, to meet nutrient needs and prevent deficiencies and
complications from developing.
The total vitamin amounts from all sources such as nutritional
sources, other