Levocarnitine 1.5g/5ml (30%) oral solution paediatric

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

L-Carnitine

Available from:

30%) oral solution paediatric (Logixx Pharma Solutions Ltd

ATC code:

A16AA01

INN (International Name):

L-Carnitine

Dosage:

300mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09080100

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOCARNITINE PAEDIATRIC 30% ORAL SOLUTION
(levocarnitine 30% w/v)
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 your child. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as your child’s
-
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 Levocarnitine Paediatric 30% Oral Solution will be
called Levocarnitine paediatric.
IN THIS LEAFLET
1.
What Levocarnitine paediatric is and what it is used for
2.
Before you give your child Levocarnitine paediatric
3.
How to give your child Levocarnitine paediatric
4.
Possible side effects
5.
How to store Levocarnitine paediatric
6.
Further information
1.
WHAT LEVOCARNITINE PAEDIATRIC IS AND WHAT IT IS USED FOR
Levocarnitine paediatric contains levocarnitine which is a type of
protein. It is used to treat primary and
secondary levocarnitine deficiency in children less than 12 years of
age, infants and newborns.
Carnitine deficiency occurs when the body has a shortage of
levocarnitne. Levocarnitine paediatric makes
up for the body’s lack of levocarnitine and helps give the body more
energy.
2.
BEFORE YOU GIVE YOUR CHILD LEVOCARNITINE PAEDIATRIC
DO NOT GIVE YOUR CHILD LEVOCARNITINE PAEDIATRIC:
-
if your child is allergic to levocarnitine or any other ingredients in
Levocarnitine paediatric . These
ingredients are listed in section 6 of this leaflet.
If this applies to your child, do not give them Levocarnitine
paediatric.
TELL YOUR DOCTOR BEFORE YOU GIVE YOUR CHILD LEVOCARNITINE PAEDIATRIC
IF:
-
your child has severe kidney problems or kidney disease and is having
dialysis
-
your child is diabetic and taking insulin, or any other drug to treat
their diabetes
-
your child is a diabetic or is on a diet to reduce

Summary of Product characteristics

OBJECT 1
LEVOCARNITINE 30% PAEDIATRIC ORAL SOLUTION
Summary of Product Characteristics Updated 22-Jan-2018 | Logixx Pharma
Solutions Ltd
1. Name of the medicinal product
Levocarnitine Paediatric 30% Oral Solution
2. Qualitative and quantitative composition
Levocarnitine 30% w/v
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Colourless or slightly yellow oral solution
4. Clinical particulars
4.1 Therapeutic indications
Indicated for the treatment of primary and secondary carnitine
deficiency in children of under 12 years,
infants and newborns.
4.2 Posology and method of administration
For oral administration only. The Paediatric Solution can be drunk
directly or diluted further in water or
fruit juices.
CHILDREN UNDER 12 YEARS, INFANTS AND NEWBORNS:
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 Levocarnitine then
maintenance therapy can be considered using 1g per day of
Levocarnitine orally. On the day of the
dialysis oral Levocarnitine 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 pat