Levocarnitine Paediatric 30%w/v Oral Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVOCARNITINE

Available from:

Cenote Pharma Ltd Elizabeth House 13-19 London Road Newbury, Berkshire RG14 1JL, United Kingdom

ATC code:

A16AA01

INN (International Name):

LEVOCARNITINE 30 % (W/V)

Pharmaceutical form:

ORAL SOLUTION

Composition:

LEVOCARNITINE 30 % (W/V)

Prescription type:

POM

Therapeutic area:

OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS

Authorization status:

Authorised

Authorization date:

2018-01-12

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOCARNITINE PAEDIATRIC 30% ORAL SOLUTION
(levocarnitine 30% w/v (300mg/ml)
Sugar Free
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 your child. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as your child’s.
-
If your child gets any side effects, talk to your doctor or
pharmacist. This includes any possible side
effect not listed in this leaflet. See section 4.
-
In this leaflet Levocarnitine Paediatric 30% Oral Solution will be
called Levocarnitine paediatric.
WHAT IS IN THIS LEAFLET
1.
What Levocarnitine paediatric is and what it is used for
2.
What you need to know 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.
Contents of the pack and other 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.
Levocarnitine deficiency occurs when the body has a shortage of
levocarnitine. Levocarnitine paediatric
makes up for the body’s lack of levocarnitine and helps give the
body more energy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE YOUR CHILD LEVOCARNITINE
PAEDIATRIC
DO NOT GIVE YOUR CHILD LEVOCARNITINE PAEDIATRIC:
-
if your child is allergic to levocarnitine or any of the other
ingredients in this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to 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 an

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levocarnitine Paediatric 30% Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levocarnitine 30% w/v (300mg/ml)
Excipients with known effect
Sorbitol solution (70%) (E420)
Sodium propyl hydroxybenzoate (E217)
Sodium methyl hydroxybenzoate (E219)
Sucrose
Hydrochloric acid, concentrated (for pH-adjustment)(E507)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Colourless to yellowish, clear solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levocarnitine Paediatric 30% Oral Solution is 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
POSOLOGY
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.
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Maximum dose for children is 1g daily if used as a maintenance therapy
for secondary deficiency in
dialysis patients
METHOD OF ADMINISTR