Table of Contents
1. Name of the medicinal product
2. Qualitative and quantitative composition
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. Pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
1. Name of the medicinal product
 Carnitor 30% Paediatric Oral Solution
2. Qualitative and quantitative composition
 L-Carnitine inner salt 30% w/v
3. Pharmaceutical form
 Colourless or slightly yellow 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 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 L-carnitine to diabetic patients receiving either insulin or hypoglycaemic oral treatment may result in hypoglycaemia. Plasma glucose levels in these subjects must be monitored regularly in order to adjust the hypoglycaemic treatment immediately, if required.
The 30% oral solution contains sucrose. This must be considered when treating diabetics or patients who are following diets to reduce calorie intake.
The safety and efficacy of oral L-carnitine has not been eva luated in patients with re