LEVOCARNITINE PAEDIATRIC 30% Oral solution

Active ingredients: L-carnitine

Product name and form

Levocarnitine Paediatric 30% Oral Solution.

Pharmaceutical Form

Oral solution.

Colourless to yellowish, clear solution.

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.

Active Ingredient
Description

Levocarnitine as a factor is necessary in the transport of long-chain fatty acids into the mitochondria-facilitating the oxidation of fatty acids rather than their incorporation into triglycerides.

List of Excipients

Sorbitol solution (70%) (E420)
Sodium propyl hydroxybenzoate (E217)
Sodium methyl hydroxybenzoate (E219)
Sucrose
Hydrochloric acid,concentrated (E507) (for pH-adjustment)

Pack sizes and marketing

Carton box that contains an amber glass bottle with 20ml of drug product, with a plastic polypropylene and low density polyethylene child proof cap and a graduated dosage pipette, along with the patient information leaflet.

Marketing authorization holder

Cenoté Pharma Ltd., Griffins Court, 24-32 London Road, Newbury, Berkshire, RG14 1JX, UK

Marketing authorization dates and numbers

PL 46052/0001

11/01/2018