Cernevit

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ascorbic acid 125mg; Biotin 69ug; Cocarboxylase tetrahydrate 5.8mg; Colecalciferol 5.5ug equivalent to 220 IU;  ; Cyanocobalamin 6ug; Dexpanthenol 16.15mg; dl-Alpha tocopherol 10.2mg; Folic acid 414ug; Nicotinamide 46mg;  ; Pyridoxine hydrochloride 5.5mg;  ; Retinol palmitate 3500 [iU]; Riboflavin sodium phosphate 5.67mg

Available from:

Baxter Healthcare Ltd

INN (International Name):

Ascorbic acid 125 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Ascorbic acid 125mg Biotin 69ug Cocarboxylase tetrahydrate 5.8mg Colecalciferol 5.5ug equivalent to 220 IU   Cyanocobalamin 6ug Dexpanthenol 16.15mg dl-Alpha tocopherol 10.2mg Folic acid 414ug Nicotinamide 46mg   Pyridoxine hydrochloride 5.5mg   Retinol palmitate 3500 [iU] Riboflavin sodium phosphate 5.67mg Excipient: Glycocholic acid

Units in package:

Vial, glass, Brown, Type I,10mL, 10 dose units

Class:

General sale

Prescription type:

General sale

Manufactured by:

DSM Nutritional Products (UK) Ltd

Therapeutic indications:

CERNEVIT is indicated in adults and children over 11 years of age requiring parenteral multivitamins supplementation to correct or prevent vitamin deficiencies when oral administration is contraindicated, impossible or insufficient.

Product summary:

Package - Contents - Shelf Life: Vial, glass, Brown, Type I,10mL - 10 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, Brown, Type I - 10 mL - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1998-09-01

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Cernevit Data Sheet 1 May 2023
Baxter Healthcare Ltd
Page
1
of
14
1
PRODUCT NAME
CERNEVIT (powder for injection).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Content of lyophilisate in each vial.
_Active Ingredients _
_Quantity _
_Corresponding to _
_Quantity _
Retinol (present as retinyl palmitate)
3500IU
Vitamin A
3500IU
Colecalciferol
5.5μg
Vitamin D3
5.5μg
dl‐α‐tocopherol
10.20mg
Alpha tocopherol (Vitamin E)
11.20IU
Ascorbic acid
125mg
Vitamin C
125mg
Cocarboxylase tetrahydrate
5.80mg
Thiamine (Vitamin B1)
3.51mg
Riboflavin sodium phosphate
5.67mg
Riboflavin (Vitamin B2)
4.14mg
Pyridoxine hydrochloride
5.50mg
Pyridoxine (Vitamin B6)
4.53mg
Cyanocobalimin
6μg
Vitamin B12
6μg
Folic acid
414μg
Folic acid (Vitamin B9)
414μg
Dexpanthenol
16.15mg
Dexpantothenic acid (Vitamin B5)
17.25mg
Biotin
69μg
Biotin (Vitamin B7)
69μg
Nicotinamide
46mg
Niacin (Vitamin PP/B3)
46mg
The active ingredients in CERNEVIT are water‐soluble and
fat‐soluble vitamins, which are well
characterised.
The Glycine component is included in the formulation as an excipient
in order to facilitate the
reconstitution of the lyophilised product with Water for Injection.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for injection.
CERNEVIT is a multivitamin preparation, lyophilised, sterile powder,
for reconstitution in 5mL of
Water for Injections or other compatible parenteral fluids.
CERNEVIT is a sterile dosage form for intravenous injection or
infusion containing nine water‐soluble
and three fat‐soluble vitamins (Vitamin K is not included in
CERNEVIT), using mixed micelles
(glycocholic acid and lecithin) as a solubilising agent. It is
presented as a lyophilised, orange‐yellow,
sterile powder. That is to be reconstituted with 5mL of Water for
Injections or other parenteral
fluids, (e.g. as 0.9% Sodium chloride, 5% Glucose or nutritional
mixtures), prior to administration by
parenteral route.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
CERNEVIT is indicated in adul