Carnitor oral single dose 1g solution

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
07-06-2018
Shusha Tabia za bidhaa (SPC)
07-06-2018

Viambatanisho vya kazi:

L-Carnitine

Inapatikana kutoka:

Logixx Pharma Solutions Ltd

ATC kanuni:

A16AA01

INN (Jina la Kimataifa):

L-Carnitine

Kipimo:

100mg/1ml

Dawa fomu:

Oral solution

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 09080100; GTIN: 5022690000189

Taarifa za kipeperushi

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
CARNITOR 1 G ORAL SOLUTION
(levocarnitine)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
- 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. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours
- If any of the side effects get serious, or you notice any side
effects not listed in this leaflet
please tell your doctor or pharmacist.
- In this leaflet Carnitor 1 g Oral Solution is called Carnitor
solution.
IN THIS LEAFLET:
1. What Carnitor solution is and what it is used for
2. Before you take Carnitor solution
3. How to take Carnitor solution
4. Possible side effects
5. How to store Carnitor solution
6. Further information
1.
WHAT CARNITOR SOLUTION IS AND WHAT IT IS USED FOR
Carnitor solution contains levocarnitine which is a type of protein.
It is used to treat primary
and secondary carnitine deficiency in adults and children over 12
years of age.
Carnitine deficiency occurs when the body has a shortage of
levocarnitine. Carnitor solution
makes up for your bodies lack of levocarnitine and helps give your
body more energy._ _
_ _
2.
BEFORE YOU TAKE CARNITOR SOLUTION
DO NOT TAKE CARNITOR SOLUTION:
- if you are allergic to levocarnitine or any of the other ingredients
in Carnitor solution. These
ingredients are listed in section 6 of this leaflet.
If this applies to you, do not take Carnitor solution._ _
TELL YOUR DOCTOR BEFORE YOU TAKE CARNITOR SOLUTION IF:
- you have severe kidney problems or kidney disease and are having
dialysis
- you are diabetic and taking insulin, or any other drug to treat your
diabetes
- you are taking anticoagulant medicine, such as warfarin, or any
other drug to reduce blood
clotting.
If any of the above applies to you, talk to your doctor or pharmacist.
TAKING OTHER MEDICINES
Tell your doctor if you are taking anticoagulant medicine, such as
warfarin, or any other drug
to 
                                
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Tabia za bidhaa

                                OBJECT 1
CARNITOR ORAL SINGLE DOSE 1G
Summary of Product Characteristics Updated 22-Jan-2018 | Logixx Pharma
Solutions Ltd
1. Name of the medicinal product
Carnitor 1 g Oral Solution
2. Qualitative and quantitative composition
Levocarnitine 1.0g
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Clear, colourless or light straw- coloured solution.
4. Clinical particulars
4.1 Therapeutic indications
Indicated for the treatment of primary and secondary carnitine
deficiency in adults and children over 12
years of age.
4.2 Posology and method of administration
For oral administration only. The Oral Solution can be drunk directly
or diluted further in water or fruit
juices.
ADULTS AND CHILDREN OVER 12 YEARS OF AGE
It is advisable to monitor therapy by measuring free and acyl
carnitine levels in both plasma and urine.
THE MANAGEMENT OF INBORN ERRORS OF METABOLISM
The dosage required depends upon the specific inborn error of
metabolism concerned and the severity of
presentation at the time of treatment. However, the following can be
considered as a general guide.
An oral dosage of up to 200mg/kg/day in divided doses (2 to 4) is
recommended for chronic use in some
disorders, with lower doses sufficing in other conditions. If clinical
and biochemical symptoms do not
improve, the dose may be increased on a short-term basis. Higher doses
of up to 400mg/kg/day may be
necessary in acute metabolic decompensation or the i.v. route may be
required.
HAEMODIALYSIS - MAINTENANCE THERAPY
If significant clinical benefit has been gained by a first course of
intravenous Carnitor then maintenance
therapy can be considered using 1g per day of Carnitor orally. On the
day of the dialysis oral Carnitor has
to be administered at the end of the session.
4.3 Contraindications
Hypersensitivity to any of the constituents of the product.
4.4 Special warnings and precautions for use
While improving glucose utilisation, the administration of
levocarnitine to diabetic patients receiving
either insulin or hypoglycaemic oral treatm
                                
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