carnitine is a natural component of cells in which plays a fundamental role in processes of synthesis and transportation of energy. Represents actually only irreplaceable factor for process of penetration of long-chain fatty acids into mitochondrions and their participation in β-oxidation. Besides, the carnitine controls transportation of the energy developed by mitochondrions in cytoplasm by means of adeninnukleotidtranslokaza enzyme modulation.

Structure

active ingredient: levocarnitine;

1 bottle (10 ml) of medicament contains to a left carnitine 2 g

excipients: malic acid, Natrium benzoicum (E 211), sodium saccharin, orange fragrance, the water purified.

Indication

Primary and secondary karnitinova insufficiency.

Contraindication

Hypersensitivity to active ingredient or to medicament excipients.

Medicine is intended to

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for oral administration. Before use solution should be dissolved in a glass of water and to accept in 30 minutes prior to food. To use the dosing syringe or a measured glass to dosing.

At use of medicine it is reasonable to p to control the level of a free carnitine and acyl carnitine both in blood plasma, and in urine.

Dosage

establishes

Dose and duration of treatment to

by a left carnitine the doctor individually depending on age, body weight and a nosological form of a disease of the patient.

Adult

Primary and secondary deficit of a carnitine

Dosage depends on specific congenital disbolism and weight of a condition of the patient during treatment.

generally, the recommended oral dose makes from 100 to 200 mg/kg a day in 2-4 receptions, at less serious states the dose can be less (50-100 mk/kg in day).

If clinical and biochemical sign do not improve, the dose can be increased by the short period.

In acute metabolic disorders higher doses (up to 400 mg/kg/days) or introduction to a left carnitine in a daily dose of 100 mg/kg can be required.

Secondary deficit of a carnitine at patients to whom carry out a hemodialysis.

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If achieved considerable clinical results after the first course of introduction, it is possible to perform maintenance therapy in a dose of 1 g a day by oral administration. In day of dialysis the oral administration of medicine is carried out after the procedure.

Maximum daily dose for adults makes 6 g (30 ml).

Average course of treatment for adults and children makes 1-3 months. In case of need the course of treatment can be repeated. In case of primary and secondary karnitinovoa of insufficiency, medicament should be used constantly or before elimination of the reason of the last.

Children

Medicine to apply

to children from the first day of life, including premature. Solution is accepted, since a dose of 50 mg/kg a day. The usual dose for children makes 50-100 mg/kg a day (see the Table).

Age	Single dose	Number of receptions in day
Newborn	100 mg (0.5 ml)	2-3
Children aged till 1 year	100-200 mg (0.5-1 ml)	2-3
Children at the age of 1-3 years	200-400 mg (1-2 ml)	3
Children of 4-6 years	400-600 mg (2-3 ml)	3
Children of 7-11 years	500-800 mg (2.5-4 ml)	3
Children are more senior than 12 years	800-1000 mg (4-5 ml)	3

Maximum daily dose to children makes 3 g (15 ml).

Overdose

Overdose or prolonged use to a left carnitine can lead

to diarrhea. Levokarnitin easily leaves from blood plasma by dialysis.

Side reactions

Side reactions (according to clinical trials, literature and postregistration experience) are given by

on classes of systems of bodies according to medical the dictionary of regulatory activity MedDRA and are classified by following by frequency: very often (≥1/10), it is frequent (≥1/100, <10), infrequently (≥1/1000, <100), is rare (≥1/10000, <100), is very rare (<1/10000), frequency is unknown (frequency cannot be estimated on the available data). Within each frequency group side reactions the severity specified in decreasing order.

from nervous system:

infrequently - a headache frequency is unknown to

- sudorogi1, dizziness.

from heart:

frequency is unknown to

- heartbeat.

from vessels:

infrequently - arterial hypotension, arterial hypertension.

from the respiratory system, bodies of a thorax and mediastinum:

frequency is unknown to

- an asthma.

from a digestive tract:

it is frequent - nausea, vomiting, diarrhea, an abdominal pain infrequently - a dysgeusia, dyspepsia, dryness in a mouth.

from skin and hypodermic fabrics:

infrequently - an abnormal smell tela2; frequency is unknown - an itching, rash.

from a musculoskeletal system and connective tissue:

infrequently - muscular spasms; frequency is unknown - miasteniya3, muscular tension.

General disorders and disturbances in the injection site:

it is frequent - a stethalgia, abnormal feelings, a pyrexia.

Research:

infrequently - increase in arterial blood pressure; very seldom - increase in MHO4.

Feature of use

Use during pregnancy or feeding by a breast

Pregnancy

Teratogenic action. At use of the most studied dose of 600 mg/kg of body weight for animals noted statistically insignificant increase in frequency of a postimplantatsiynoa of death of a fruit in the early stages of pregnancy. The importance of these results for the person is unknown.

Adequate clinical trials with participation of pregnant women was not carried out. During pregnancy medicament should be used if the advantage of its use for the woman exceeds potential risk for a fruit.

feeding Period a breast

Levokarnitin - a usual component of human milk. Use to a left carnitine nursing was not studied. During feeding by a breast medicament should be used if the advantage of its use for the woman exceeds the potential risk for the child caused by excessive exposure of a carnitine.

Fertility

In clinical trials did not reveal negative influence on fertility.

Medicine children can apply

from the first day of life.

Ability to influence speed of response at control of motor transport or other mechanisms.

Levokarnitin does not affect ability to run motor transport or other mechanisms.

Interaction with other medicines and other types of interactions

Cannot exclude interactions between a left carnitine and medicaments of coumarin. Seldom or never reported about increase in the international normalized relation (INR) at simultaneous use to a left carnitine with coumarin medicaments (see the Sections "Features of Use", "Side reactions"). In case of simultaneous use of these means it is necessary to carry out monitoring of MNO or to carry out other tests for coagulation weekly to stabilization and monthly further (see the Section "Features of Use").

Simultaneous use to a left carnitine with means, induce a gipokarnitinemiya of strengthening of removal of a carnitine kidneys (for example, the valproic acid, pro-medicaments containing a pivalonova acid, cephalosporins, Cisplatinum, karboplatin, ifosfamid), can reduce its level.

to Store

at a temperature not above 25 °C out of children's reach.

Expiration date - 4 years.