Ketovite Liquid

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Vitamin a palmitate; Ergocalciferol; Choline chloride; Cyanocobalamin

Fáanlegur frá:

Taw Pharma (Ireland) Ltd

ATC númer:

A11BA

INN (Alþjóðlegt nafn):

Vitamin a palmitate; Ergocalciferol; Choline chloride; Cyanocobalamin

Lyfjaform:

Oral solution

Lækningarsvæði:

Multivitamins, plain

Leyfisstaða:

Not marketed

Leyfisdagur:

2012-05-25

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
KETOVITE LIQUID
MULTIVITAMIN PREPARATION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Ketovite Liquid is and what it is used for
2.
What you need to know before you take Ketovite Liquid
3.
How to take Ketovite Liquid
4.
Possible side effects
5.
How to store Ketovite Liquid
6.
Contents of the pack and other information
1.
WHAT KETOVITE LIQUID IS, AND WHAT IT IS USED FOR
Ketovite Liquid is a sugar-free therapeutic supplement for the
prevention of vitamin deficiency. It is
used in conditions such as:
-
galactosemia (a disorder of milk sugar digestion)
-
disaccharide intolerance (a reaction to sugars such as sucrose,
lactose and maltose)
-
phenylketonuria (an inability to digest one of the essential amino
acids)
-
in other disorders of starch, sugar or amino acid metabolism
-
in patients who are on restricted, specialised or synthetic diets
Ketovite Liquid is a multivitamin preparation, intended for use at the
same time as Ketovite Tablets.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE KETOVITE LIQUID
DO NOT TAKE KETOVITE LIQUID
-
If you are ALLERGIC to the active substances or ANY OF THE INGREDIENTS
of this medicine (listed in
section 6).
-
If you have HYPERCALCAEMIA (high blood calcium level).
-
If you are taking OTHER VITAMIN PREPARATIONS, especially those
containing Vitamins A and D,
such as cod-liver oil.
WARNINGS AND PRECAUTIONS
-
If you have trouble digesting fatty foods as the absorption of some of
the vitamins may be
reduced.
OTH

Vara einkenni

Health Products Regulatory Authority
21 January 2022
CRN00CQH9
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ketovite Liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains:
Vitamin A (as palmitate) 2,500 IU
Ergocalciferol (Vitamin D
2
) 400 IU
Cyanocobalamin 12.5 micrograms
Choline chloride 150 mg
Excipient(s) with known effect
5 ml solution contains 7.5 mg methyl parahydroxybenzoate (E218).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution (oral liquid).
A pale pink to yellow liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a sugar-free therapeutic supplement for the prevention of vitamin
deficiency in conditions such as galactosaemia,
disaccharide intolerance, phenylketonuria and other disorders of
carbohydrate or amino acid metabolism, as well as in patients
who are on restricted, specialised or synthetic diets.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For adults, children and the elderly: 5 ml daily.
Method of administration
For oral use.
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.

Hypercalcaemia.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The recommended dose should not be exceeded without medical advice. No
other vitamin supplement
containing Vitamins A and D should be taken with Ketovite except under
medical supervision.
Warning: do not exceed the stated dose.
Prolonged excessive ingestion of Vitamin A and Vitamin D can lead to
hypervitaminosis states which may occur if foods high in
this vitamin, (for example liver), are ingested in association with
the recommended doses of this product.
Methyl parahydroxybenzoate
This medicinal product contains methyl parahydroxybenzoate (E218). May
cause allergic reactions
Health Products Regulatory Authority
21 January 2022
CRN00CQH9
Page 2 of 4
(possibly delayed).
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
Absorption of some vitamins in this preparati