Li-Liquid 509mg/5ml oral solution

国: イギリス

言語: 英語

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

即購入

ダウンロード 製品の特徴 (SPC)
09-06-2018

有効成分:

Lithium citrate

から入手可能:

Rosemont Pharmaceuticals Ltd

ATCコード:

N05AN01

INN(国際名):

Lithium citrate

投薬量:

101.8mg/1ml

医薬品形態:

Oral solution

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 04020300; GTIN: 5016119058899

情報リーフレット

                                Li-Liquid™ 509mg/5ml Oral Syrup
(Lithium Citrate)
JOB INFORMATION
COLOURS
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TICK APPLICABLE BOX
Tabbed:
Keyline Ref:
210 x 300mm
UKL412
150 x 30mm
No
Dimensions:
Folded Size:
H2YD1RBJ2
New Item Code:
H2YD1RBJ1
Previous Item Code:
N/A
Supplier Code:
150ml
Pack Size:
150ml
Bottle Size:
509mg/5ml
Strength:
N/A
1 of 2
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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 signs of illness
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 Li-Liquid is and what it is used for
4. Possible side effects
2. What you need to know before you take Li-Liquid
5. How to store Li-Liquid
3. How to take Li-Liquid
6. Contents of the pack and other information
1. WHAT LI-LIQUID IS AND WHAT IT IS USED FOR
The name of your medicine is Li-Liquid 509mg/5ml Oral Syrup (referred
to as Li-Liquid in this leaflet). It contains
lithium citrate. This belongs to a group of medicines called
‘anti-manics’.
Lithium acts on the brain to calm your moods and emotions.
Lithium can be used to:
■
t
                                
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製品の特徴

                                OBJECT 1
LI-LIQUID 509 MG/5ML ORAL SYRUP
Summary of Product Characteristics Updated 23-Jan-2018 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Li-Liquid 509mg/5ml Oral Syrup
2. Qualitative and quantitative composition
Lithium Citrate Tetrahydrate
509mg/5ml
equivalent to Lithium Ion
5.4mmol
equivalent to Lithium
Carbonate
200mg
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for oral administration
4. Clinical particulars
4.1 Therapeutic indications
• Treatment of mania and hypomania
• Treatment of recurrent bipolar depression, where the use of
alternative anti-depressants has been
ineffective
• Prophylactic treatment of recurrent affective disorders
• Control of aggressive or self mutilating behaviour
Treatment should be directed to stabilise manic depressive illness
rather than to establish early control of
acute episodes.
4.2 Posology and method of administration
Dosage must be individualised depending on serum lithium levels and
clinical response. The dosage
necessary to maintain serum lithium levels within the therapeutic
range varies from patient to patient. The
minimum effective dose should be sought and maintained.
For oral administration only.
A simple treatment schedule has been evolved which except for some
minor variations should be
followed whether using Li-Liquid therapeutically or prophylactically.
The minor variations to this
schedule depend on the elements of the illness being treated and these
are described later.
ADULTS:
1. In patients of average weight (70 kg) an initial total daily dose
of 1018 – 3054mg Lithium citrate
(equivalent to 400 - 1200mg Lithium carbonate which is 10-30ml of
liquid) should be given in divided
doses, in the morning and in the evening.
When changing between lithium preparations, serum lithium levels
should first be checked, then Li-liquid
therapy commenced at a daily dose as close as possible to that of the
other form of lithium. As
bioavailability varies from product to product (particularly with
regard to
                                
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