Dalivit

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ERGOCALCIFEROL, ASCORBIC ACID, NICOTINAMIDE, THIAMINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE, RETINOL PALMITATE, RIBOFLAVIN

Available from:

Boston Healthcare Limited Unit 6, Navigation Court, Calder Park, Wakefield, West Yorkshire WF2 7JB, United Kingdom

ATC code:

A11JA

INN (International Name):

ERGOCALCIFEROL 400 U ASCORBIC ACID 50 mg NICOTINAMIDE 5 mg THIAMINE HYDROCHLORIDE 1 mg PYRIDOXINE HYDROCHLORIDE 500 µg RETINOL PALMITATE 5000 U RIBOFLAVIN 400 µg

Pharmaceutical form:

ORAL DROPS, SOLUTION

Composition:

ERGOCALCIFEROL 400 U ASCORBIC ACID 50 mg NICOTINAMIDE 5 mg THIAMINE HYDROCHLORIDE 1 mg PYRIDOXINE HYDROCHLORIDE 500 µg RETINOL PALMITATE 5000 U RIBOFLAVIN 400 µg

Prescription type:

OTC

Therapeutic area:

VITAMINS

Authorization status:

Withdrawn

Authorization date:

2006-04-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DALIVIT DROPS
(Vitamin A Palmitate, Vitamin D2, Vitamin B1,
Vitamin B2, Vitamin B6, Vitamin C, Nicotinamide)
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR YOU.
This medicine is available both with or without prescription. However, you 
still need to use Dalivit Drops carefully to get the best results from it.
•  Keep this leaflet. You may need to read it again.
•  If you have any further questions, ask your doctor or pharmacist.
•  This medicine has been prescribed for you. Do not pass it on to others.
  It may harm them, even if their symptoms are the same as yours.
•  If any of the side effects gets serious, or if you notice any side effect
  not listed in this leaflet, please tell your doctor or pharmacist.
  IN THIS LEAFLET

  1.  What Dalivit Drops are and what they are used for
  2.  Before you take Dalivit Drops
  3.  How to give/use Dalivit Drops
  4.  Possible side effects
  5.  How to store Dalivit Drops
  6.  Further information
  1.  WHAT DALIVIT DROPS ARE AND WHAT THEY
     ARE USED FOR
The name of this medicine is Dalivit Drops.
Dalivit Drops are a multivitamin preparation and contain seven
essential 
vitamins. The necessary vitamins are usually provided by a balanced
diet, 
but if any of the essential vitamins are absent from food for long
periods of 
time, poor growth or certain deficiency diseases can occur.
This medicine helps prevent vitamin deficiencies and to maintain
normal 
growth and health during the early years of infancy and childhood.
Specific functions of active ingredients −
•   Vitamin A and Vitamin D2 are for the development of bones,
teeth and 
  skin and the prevention of rickets.
•   Vitamins B1, B2, B6 and Nicotinamide are for the development
and
  functioning of the nervous system.

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS 

1 NAME OF THE MEDICINAL PRODUCT 
Dalivit Drops 

2 QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each 0.6 ml contains: 
Vitamin A Palmitate BP 5,000 units 
Ergocalciferol (Vitamin D
2
) Ph Eur 400 units 
Thiamine hydrochloride BP 1 mg 
(Vitamin B1) 
Riboflavin (Vitamin B2) BP 400 micrograms 
Pyridoxine hydrochloride BP 500 micrograms 
(Vitamin B6) 
Ascorbic acid (Vitamin C) BP 50 mg 
Nicotinamide BP 5 mg 
_Excipient(s): _
This product contains Sucrose. 
This product also contains E219 Sodium Methylhydroxybenzoate. 
For a full list of excipients, see section 6.1. 

3 PHARMACEUTICAL FORM 
Oral Drops, Emulsion (Oral Drops) 
Yellowish orange coloured liquid, slightly viscous. 

4 CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 
As a supplement for the prevention of vitamin deficiency states.
As an aid to 
the maintenance of normal health and growth in infants
and young children. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 
Method of administration 
To be administered by oral route. 

_Dose: _
Infants from 6 weeks to one year : 0.3 ml daily (7 drops). 
Older children, adults and elderly: 0.6 ml daily (14 drops) or as
directed by 
the physician. 

4.3 CONTRAINDICATIONS 
Hypersensitivity to any of the active substances or any of
the excipients. 
Contra-indicated in hypercalcaemia. 
Contra-indicated in women who are (or may become) pregnant
(see 4.6). 

4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
When multivitamin preparations
are prescribed allowance must be made for 
vitamins from other sources. No other preparations contain vitamin A
should 
be taken with this preparation except under medical supervision. 
Patients with rare hereditary problems
of fructose intolerance, glucosegalactose 
malabsorption or sucrase-isomaltase insufficiency should not take 
this medicine. 
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