Ketovite liquid

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Vitamin A; Ergocalciferol; Choline chloride; Cyanocobalamin

Beschikbaar vanaf:

Rosemont Pharmaceuticals Ltd

ATC-code:

A11JA

INN (Algemene Internationale Benaming):

Vitamin A; Ergocalciferol; Choline chloride; Cyanocobalamin

Dosering:

500unit/1ml ; 80unit/1ml ; 30mg/1ml ; 2.5microgram/1ml

farmaceutische vorm:

Oral emulsion

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Never Valid To Prescribe As A VMP

Product samenvatting:

BNF: 09060700; GTIN: 5015001128153

Bijsluiter

Ketovite Liquid
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150 ml
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150 ml
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Package leaflet: Information for the user
Ketovite Liquid
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 ami

Productkenmerken

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.
In order to achieve complete vitamin supplementation Ketovite Liquid
should be used
in conjunction with Ketovite Tablets.
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.
Methyl parahydroxybenzoate
This medicinal product contains methyl parahydroxybenzoate (E218). May
cause
allergic reactions (possibly delayed).
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Absorption of some vitamins in this preparation may be reduced in
conditions of fat
malabsorption or with the concurrent use of neomycin, colestyramine,
liquid paraffin,
aminoglycosides, aminosalicylic acid, anticonvulsants, biguanides,
chloramphenicol,
cimetidine, colchicine, potassium salts and methyl-dop