KETOVITE LIQUID

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RETINOL PALMITATE ; ERGOCALCIFEROL ; CHOLINE CHLORIDE ; CYANOCOBALAMIN

Available from:

Essential Pharmaceuticals Limited

ATC code:

A11BA

INN (International Name):

RETINOL PALMITATE ; ERGOCALCIFEROL ; CHOLINE CHLORIDE ; CYANOCOBALAMIN

Dosage:

0 %v/v

Pharmaceutical form:

Infus/Pdr/Oral Soln

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Multivitamins, plain

Authorization status:

Marketed

Authorization date:

1987-11-10

Patient Information leaflet

EP00104
EP00104
F1167
Important information about some of the ingredients of Ketovite Liquid
This medicine contains methyl parahydroxybenzoate (E218), which may
cause allergic reactions (possibly
delayed).
3. HOW TO TAKE KETOVITE LIQUID
Dosage
Always take Ketovite Liquid exactly as your doctor has told you to.
You should check with your doctor or
pharmacist if you are not sure. The usual dose is 5 ml daily.
If you take more Ketovite Liquid than you should
Do not take more than you have been prescribed or than is recommended,
as this may lead to too high a
dose level, particularly of Vitamin A and Vitamin D.
If you forget to take Ketovite Liquid
You may take the dose later on during the same day. Do not take a
double dose to make up for a forgotten
dose.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
There are usually no undesirable effects after taking Ketovite Liquid.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects
not listed in this leaflet. You can also report side effects directly
(see details below). By reporting side
effects you can help provide more information on the safety of this
medicine.
United Kingdom
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: [phone]
Fax: [phone]
www.hpra.ie
email: [e-mail]
5. HOW TO STORE KETOVITE LIQUID
Keep out of the reach and sight of children.
Do not use Ketovite Liquid after the expiry date which is stated on
the bottle after Exp. Date. The expiry date
refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Ketovite Liquid contains
The active ingredients are vitamin A (as palmitate) 2500 I

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ketovite Liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains:
Excipients: also includes methyl parahydroxybenzoate (E218) 7.5mg/5ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution (oral liquid)
Pale pinkish clear to opalescent 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
For adults, children and the elderly: 5 ml daily, by oral
administration.
4.3 CONTRAINDICATIONS
Hypersensitivity to the product. 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 Liquid except under
medical supervision.
The methyl parahydroxybenzoate (E218) in Ketovite Liquid may cause
allergic reactions which can be delayed.
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.
Vitamin A (as palmitate)
2500
IU
Ergocalciferol (Vitamin D
2
)
400
IU
Cyanocobalamin
12.5
micrograms
Choline chloride
150.0
mg
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