CERNEVIT multivitamin powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

riboflavine sodium phosphate, Quantity: 5.67 mg; pyridoxine hydrochloride, Quantity: 5.5 mg; cyanocobalamin, Quantity: 6 microgram; nicotinamide, Quantity: 46 mg; dl-alpha-tocopherol, Quantity: 10.2 mg; ascorbic acid, Quantity: 125 mg; retinol palmitate, Quantity: 3500 IU; colecalciferol, Quantity: 5.5 microgram; dexpanthenol, Quantity: 16.15 mg; Biotin, Quantity: 69 microgram; cocarboxylase tetrahydrate, Quantity: 5.8 mg (Equivalent: thiamine, Qty 3.51 mg); folic acid, Quantity: 414 microgram

Available from:

Baxter Healthcare Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: glycine; glycocholic acid; hydrochloric acid; sodium hydroxide; lecithin

Administration route:

Intravenous Infusion

Units in package:

1 vial, 10 vials, 20 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Cernevit is indicated in adults and children over 11 years of age requiring parenteral multivitamin supplementation to correct or prevent vitamin deficiencies when oral administration is contraindicated, impossible or insufficient. The product does not contain vitamin K, which may be given separately if required.

Product summary:

Visual Identification: ODOURLESS ORANGE YELLOW CAKE; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2003-01-28

Patient Information leaflet

CERNEVIT
_Multivitamin powder for injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about
CERNEVIT MULTIVITAMIN
POWDER FOR INJECTION.
It does not contain all of the
available information. All
medicines have risks and
benefit. Your doctor has
weighed the risks of you using
Cernevit against the benefit
they expect it will have for
you.
It does not take the place of
talking to your doctor or
pharmacist.
IF YOU HAVE ANY CONCERNS
ABOUT BEING ADMINISTERED THIS
MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET; you may
need to read it again.
WHAT CERNEVIT IS USED
FOR?
This medicine belongs to the
vitamins, mineral and other
nutritional supplements group
of medicines. It is a
multivitamin preparation of
both water and fat-soluble
vitamins (without Vitamin K)
stabilised with a mixture of
solubilising agent. This
medicine is used as a
multivitamin supplement
corresponding your daily
needs and is given as an
injection or infusion directly
into the vein (intravenously).
BEFORE YOU ARE GIVEN
CERNEVIT
_ _
_CERNEVIT SHOULD NOT BE _
_GIVEN TO YOU IF:_
•
You have had an allergic
reaction to any of the
ingredients of Cernevit
listed in the Ingredients
section of this leaflet,
_especially thiamine _
_(Vitamin B_
_1_
_)_ or soy/protein
products. Some of the
symptoms of an allergic
reaction may include skin
rash, peeling of the skin,
itching or hives, swelling of
the face, lips or tongue
which may cause difficulty
in swallowing or breathing
or shortness of breath.
•
You have an impairment
with liver function. You are
suffering from
hyperparathyroidism due to
abnormally elevated
calcium levels in the blood.
•
The expiry date (EXP)
printed on the pack has
passed.
_YOU MUST TELL YOUR DOCTOR IF:_
•
You are allergic to
thiamine (Vitamin B
1
),
nicotinamide components
of this product, any other
medicines, foods, dyes, or
preservatives.
•
You have any other
health problems including:
- Kidney disease
- Active inflammatory
bowel disease
- You are currently
receivi

Summary of Product characteristics

CERNEVIT
Version 1.0
1 of 16
AUSTRALIAN PRODUCT INFORMATION – CERNEVIT
POWDER FOR INTRAVENOUS INJECTION
1
NAME OF THE MEDICINE
Retinol
palmitate, colecalciferol, dl-alpha-tocopherol, ascorbic acid,
cocarboxylase tetrahydrate,
riboflavine sodium phosphate, pyridoxine hydrochloride,
cyanocobalamin, folic acid,
dexpanthenol, biotin and nicotinamide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CERNEVIT is a multivitamin preparation, lyophilised, sterile powder,
for reconstitution in 5 mL
of Water for Injections or other compatible parenteral fluids.
Content of lyophilisate in each vial
ACTIVE INGREDIENTS
Qty
CORRESPONDING TO
Qty
Retinol
palmitate
3500 IU
Vitamin A
3500 IU
Colecalciferol
5.5 µg
Vitamin D3
5.5 µg
dl-alpha-tocopherol
10.20 mg
Alpha tocopherol (Vitamin E)
11.20 IU
Ascorbic acid
125 mg
Vitamin C
125 mg
Cocarboxylase tetrahydrate
5.80 mg
Thiamine (Vitamin B1)
3.51 mg
Riboflavine sodium phosphate
5.67 mg
Riboflavine
(Vitamin B2)
4.14 mg
Pyridoxine hydrochloride
5.50 mg
Pyridoxine (Vitamin B6)
4.53 mg
Cyanocobalamin
6 µg
Vitamin B12
6 µg
Folic acid
414 µg
Folic acid (Vitamin B9)
414 µg
Dexpanthenol
16.15 mg
Dexpanthenoic acid (Vitamin B5)
17.25 mg
Biotin
69 µg
Biotin (Vitamin B7)
69 µg
Nicotinamide
46.0 mg
Niacin (Vitamin PP/B3)
46 mg
_EXCIPIENTS:_
Glycine 250 mg, Glycocholic acid 140 mg, Lecithin 112.5 mg, (Lecithin
[Soybean]
112.5 mg), Sodium hydroxide 10% qs and/or, 1 M hydrochloric acid qs pH
5.9.
The active ingredients in CERNEVIT are water-soluble and fat-soluble
vitamins, which are well
ATTACHMENT 2B
CERNEVIT
Version 1.0 2 of 16
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.
3
PHARMACEUTICAL FORM
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