Cernevit, Powder for Solution for Injection or Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Retinol palmitate; Cholecalciferol; Dl-a-tocopherol; Ascorbic acid; Cocarboxylase tetrahydrate; Riboflavin sodium phosphate; Pyridoxine hydrochloride ; Cyanocobalamin; Folic acid; Dexpanthenol; D-biotin; Nicotinamide

Available from:

Baxter Holding B.V.

ATC code:

A11BA

INN (International Name):

Retinol palmitate; Cholecalciferol; Dl-a-tocopherol; Ascorbic acid; Cocarboxylase tetrahydrate; Riboflavin sodium phosphate; Pyridoxine hydrochloride ; Cyanocobalamin; Folic acid; Dexpanthenol; D-biotin; Nicotinamide

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

Multivitamins, plain

Authorization status:

Marketed

Authorization date:

1993-01-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CERNEVIT Powder for Solution for Injection or Infusion
Read all of this leaflet carefully before this medicine is given to
you because it contains
important information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
•
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1.
What CERNEVIT is and what it is used for
2.
What you need to know before CERNEVIT is given
3.
How CERNEVIT is given
4.
Possible side effects
5.
How to store CERNEVIT
6.
Contents of the pack and other information
THROUGHOUT THIS LEAFLET CERNEVIT POWDER FOR SOLUTION FOR INJECTION OR
INFUSION WILL BE
CALLED CERNEVIT.
1 WHAT CERNEVIT IS AND WHAT IT IS USED FOR
CERNEVIT is a sterile powder for solution for injections or infusion.
It contains 12 vitamins
(see section 6).
CERNEVIT is used to give your daily requirement of vitamins straight
into your blood. It is
used when you cannot take enough food by your mouth. It is usually
given with other things
such as nutrition solutions and minerals.
2 WHAT YOU NEED TO KNOW BEFORE CERNEVIT IS GIVEN
You will not be given CERNEVIT if:
•
you are allergic (hypersensitive) to the active substance or any of
the ingredients
of this medicine, especially vitamin B1 or soya protein or peanut
protein (see
Section 6, Contents of the pack and other information),
•
you have too much of one of the vitamins in CERNEVIT stored in your
body
(called ‘hypervitaminosis’).
Do not have CERNEVIT if any of the above applies to you. If you are
not sure talk to your
doctor, nurse or pharmacist.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE YOU ARE GIVEN CERNEVIT
IF:
•
you are having vitamins, espe

Summary of Product characteristics

Health Products Regulatory Authority
29 August 2019
CRN0090VQ
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cernevit, Powder for Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains:
Retinol Palmitate (Vit A)
3500
IU
Colecalciferol (Vit D
3
)
220
IU
DL-α-tocopherol (Vit E)
10.20
mg
- corresponding to α-tocopherol
11.200
IU
Ascorbic acid (Vit C)
125
mg
Cocarboxylase tetrahydrate
5.80
mg
- corresponding to Thiamine (Vit B
1
)
3.510
mg
Riboflavin dihydrated sodium phosphate (Vit B
2
)
5.67
mg
- corresponding to Riboflavin
4.14
mg
Pyridoxine hydrochloride (Vit B
6
)
5.50
mg
- corresponding to Pyridoxine
4.53
mg
Cyanocobalamin (Vit B
12
)
6
micrograms
Folic acid
414
micrograms
Dexpanthenol
16.15
mg
- corresponding to pantothenic acid
17.25
mg
D-Biotin
69
micrograms
Nicotinamide
46
mg
Excipients: Each vial contains 24mg sodium and less than 112.5mg soya
oil.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion
Orange-yellow sterile cake of lyophilised powder.
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 6.6 Instruction for use and handling
If infused intravenously, CERNEVIT should be administered slowly. If
injected intravenously, the injection must be administered
slowly (over at least 10 minutes).
Health Products Regulatory Authority
29 August 2019
CRN0090VQ
Page 2 of 10
Cernevit may be included in the composition of nutritive mixtures
combining carbohydrates, lipids, amino acids and
electrolytes provided that compat