ABIDEC MULTIVITAMIN Oral Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RETINOL PALMITATE ERGOCALCIFEROL THIAMINE HYDROCHLORIDE RIBOFLAVIN SODIUM PHOSPHATE PYRIDOXINE HYDROCHLORIDE NICOTINAMIDE ASCORBIC ACID

Available from:

LTT Pharma Limited

INN (International Name):

RETINOL PALMITATE ERGOCALCIFEROL THIAMINE HYDROCHLORIDE RIBOFLAVIN SODIUM PHOSPHATE PYRIDOXINE HYDROCHLORIDE NICOTINAMIDE

Pharmaceutical form:

Oral Drops Solution

Prescription type:

Product not subject to medical prescription

Authorization status:

Withdrawn

Authorization date:

2014-02-10

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Abidec Multivitamin Oral Drops Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Abidec Multivitamin Drops contains 1333 IU retinol (as vitamin A palmitate), 400 IU ergocalciferol, 0.4 mg thiamine
hydrochloride, 0.8 mg riboflavin sodium phosphate, 0.8 mg pyridoxine hydrochloride, 8 mg nicotinamide, and 40 mg
ascorbic acid in each 0.6 ml dose.
Excipients - contains sucrose and arachis oil (refined peanut oil)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral drops, solution
_Product imported from the UK:_
A yellow to orange brown oral drops, solution which darkens upon storage, with some cloudiness.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Abidec Multivitamin Drops is indicated for the prevention of vitamin deficiencies and for the maintenance of normal
growth and health during the early years of infancy and childhood; multivitamin supplement.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN OVER 12 YEARS:
Not appropriate.
CHILDREN AGED 1 TO 12 YEARS:
Oral.
One 0.6ml dose taken daily.
Maximum daily dose: 0.6ml.
CHILDREN UNDER 1 YEAR:
Oral.
One 0.3ml dose taken daily.
Maximum daily dose: 0.3ml.
THE ELDERLY:
Not appropriate.
HEPATIC/RENAL DYSFUNCTION:
Normal dosage is appropriate.
IRISH MEDICINES BOARD
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_Date Printed 21/09/2011_
_CRN 2105463_
_page number: 1_
4.3 CONTRAINDICATIONS
Abidec Multivitamin Drops is contra-indicated in individuals with known hypersensitivity to the product or any of its
components including peanut oil.
Vitamin A palmitate contains refined peanut oil (Arachis oil) and should not be taken by patients known to be allergic
to peanut. As there is a possible