Ketovite tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Ascorbic acid; Riboflavin; Thiamine hydrochloride; Pyridoxine hydrochloride; Nicotinamide; Calcium pantothenate; Alpha tocopheryl acetate; Inositol; Biotin; Folic acid; Acetomenaphthone

から入手可能:

Essential Pharmaceuticals Ltd

ATCコード:

A11EX

INN（国際名）:

Ascorbic acid; Riboflavin; Thiamine hydrochloride; Pyridoxine hydrochloride; Nicotinamide; Calcium pantothenate; Alpha tocopheryl acetate; Inositol; Biotin; Folic acid; Acetomenaphthone

投薬量:

16.6mg ; 1mg ; 1mg ; 330microgram ; 3.3mg ; 1.16mg ; 5mg ; 50mg ; 170microgram ; 250microgram ; 500microgram

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Never Valid To Prescribe As A VMP

製品概要:

BNF: 09060700; GTIN: 5015001128009

情報リーフレット

EACH TABLET CONTAINS:
Thiamine Hydrochloride
1.0 mg, Riboflavin 1.0 mg,
Pyridoxine Hydrochloride
0.33 mg, Nicotinamide 3.3
mg, Calcium Pantothenate
1.16 mg, Ascorbic Acid
16.6 mg, Alpha Tocopheryl
acetate 5.0 mg, Inositol
50.0 mg, Biotin 0.17 mg,
Folic Acid 0.25 mg,
Acetomenaphthone 0.5 mg.
DOSAGE: Tablets to be taken
orally and as directed by a
medical practitioner. Do not
exceed the stated dose.
Store in a refrigerator (2°C-8°C)
.
Read teh package leaflet
before use. Keep out of the
sight and reach of children.
Essential Pharmaceuticals Ltd,
Egham, Surrey,
TW20 8RB, UK.
PL 41094/0001
KETOVITE
TABLETS
Vitamin supplement
SUGAR FREE
100
tablets
FOR USE IN RESTRICTED OR THERAPEUTIC DIETS
To obtain
complete vitamin
supplement use with
Ketovite Liquid
KetTab-PL-UK-2
POM
Package leaflet: Information for the user
Ketovite Tablets
Multivitamin preparation
Read all of this leaflet carefully before you start taking this
medicine
because it contains important information for you.
• 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 only. Do not pass it on
to others. It
may harm them, even if their symptoms are the same as yours.
• 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.
What is in this leaflet
1. What Ketovite Tablets are and what they are used for
2. What you need to know before you take Ketovite Tablets
3. How to take Ketovite Tablets
4. Possible side effects
5. How to store Ketovite Tablets
6. Contents of the pack and other information
1. What Ketovite Tablets are and what they are used for
Ketovite Tablets are a therapeutic vitamin supplement for the
prevention of
vitamin deficiency. It is used in conditions such as:
• galactosaemia (a disorder of milk sugar digestion)
• disaccharide intolerance (a reaction to sugars such as sucrose,
lactose and
maltose)
• phenylketonuria (an inability to

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ketovite Tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Thiamine hydrochloride BP
1.0
mg
Riboflavin BP
1.0
mg
Pyridoxine hydrochloride
0.33
mg
Nicotinamide BP
3.3
mg
Calcium pantothenate PhEur
1.16
mg
Ascorbic acid BP
16.6
mg
Acetomenaphthone BP 1973
0.5
mg
Alpha-tocopheryl acetate BP
5.0
mg
Inositol NF XII
50.0
mg
Biotin USP
0.17
mg
Folic acid BP
0.25
mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As a 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 Tablets
should
be used in conjunction with Ketovite Liquid.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_For Adults, Children and the Elderly:_ One tablet three times a day,
by oral
administration.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in
section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Interference with clinical laboratory tests
Biotin may interfere with laboratory tests that are based on a
biotin/streptavidin interaction, leading to either falsely decreased
or falsely
increased test results, depending on the assay. The risk of
interference is
higher in children and patients with renal impairment and increases
with
higher doses. When interpreting results of laboratory tests, possible
biotin
interference has to be taken into consideration, especially if a lack
of
coherence with the clinical presentation is observed (e.g. thyroid
test results
mimicking Graves’ disease in asymptomatic patients taking biotin or
false
negative troponin test results in patients with myocardial infarction
taking
biotin). Alternative tests not susceptible to biotin