d ketone bodies but also that of glucose and some amino acids.
5.2 Pharmacokinetic properties
The absorbed L-carnitine is transported to various organ systems via the blood. The presence of membrane-bound proteins in several tissues including red blood cells that bind carnitine, suggest that a transport system in the blood and a cellular system for the collective uptake is present in several tissues. Tissue and serum carnitine concentration depend on several metabolic processes, carnitine bio-synthesis and dietary contributions, transport into and out of tissues, degradation and excretion may all affect tissue carnitine concentrations.
It has been demonstrated that pharmacokinetic parameters increase significantly with dosage. Apparent bioavailability in healthy volunteers is about 10-16%. The data suggests a relationship between maximal plasma concentration/dosage, dosage, plasma AUC, dosage/urinary accumulation. Maximum concentration is reached about four hours after ingestion.
e5.3 Preclinical safety data
L-Carnitine is a naturally occurring body substance in human beings, plants and animals. Carnitor products are used to bring the level of L-carnitine in the body up to those found naturally. Appropriate pre-clinical studies have been undertaken and show no signs of toxicity at normal therapeutic doses.
6. Pharmaceutical particulars
6.1 List of excipients
Sorbitol solution (70%) (E420), tartaric acid (E334), sodium propyl hydroxybenzoate (E217), sodium methyl hydroxybenzoate (E219), colourless cherry flavour, colourless sour black cherry flavour, saccharose and purified water.
e6.2 Incompatibilities
None known.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store below 25°C.
Store in the original carton in order to protect from light and moisture.
6.5 Nature and contents of container
20 ml amber glass bottles with a polyethylene lined, polypropylene child proof cap.
6.6 Special precautions for disposal and other handling
None
7. Marketing authorisation holder
Sigma-Tau Industrie Farmaceutiche Riunite SpA,
Viale Shakespeare 47-00144,
Rome, Italy.
8. Marketing authorisation number(s)
PL 08381/0005
9. Date of first authorisation/renewal of the authorisation
20 November 1998
10. Date of revision of the text
November 2008
More information about this product
•Patient Information Leaflets (PILs):
Carnitor Paediatric Solution 30%
•Medicine Guides:
Carnitor