Download L-Viava 1 g/10 ml 10 Vials of 10 ml

LEAFLET ON DRUG ADMINISTRATION
L-VIAVA
TRADE NAME
L-Viava
INTERNATIONAL NONPROPRIETARY NAME
Levocarnitine
PHARMACEUTICAL FORM
Oral solution.
Description: clear colourless or light yellow solution.
COMPOSITION
Vial of drug contains
Active substance: levocarnitine 1.0 g or 2.0 g.
Excipients: malic acid, sodium benzoate, saccharin sodium, orange flavor, purified water.
АТС CODE
А16АА01
PHARMACOTHERAPEUTIC GROUP
Amino acids and their derivatives.
PHARMACOLOGIC PROPERTIES
PHARMACODYNAMICS
L-Viava - drug for correction of metabolic processes.
Levocarnitine is a naturally occurring substance that is related to vitamin B complex. It is
involved in metabolic processes as a fatty acid carrier across cell membranes from cytoplasm to
mitochondria, where these acids undergo β-oxidation with the formation of a great deal of energy
(in the form of ATP). By releasing coenzyme А, levocarnitine intensifies metabolite entry into
the Krebs cycle. It stimulates the activity of pyruvate dehydrogenase in skeletal muscles and the
oxidation of branched-chain amino acids by the same mechanism. The drug improves protein
and fat metabolism, restores the blood alkaline reserve, inhibits ketoacid formation and
anaerobic glycolysis, reduces the degree of lactacidosis, as well as increases the motion activity
and improves exercise tolerance, herewith contributes to glycogen sparing and the increase in its
stores in the liver.
PHARMACOKINETICS
Bioavailability of the oral levocarnitine is 15.9%. It penetrates in all the tissues, the highest
concentrations are in liver, skeletal muscles and myocardium. Maximum concentration is
reached in 3.3 hours after administration, therapeutic concentration is maintained for 9 hours.
It is excreted by the kidneys, especially acyl ethers.
THERAPEUTIC INDICATIONS
- primary and secondary carnitine deficiency;
- carnitine deficiency in patients with terminal stage of renal failure, and on hemodialysis;
- metabolic disorders in the myocardium against CHD (acute myocardial infarction,
postinfarction state, cardiogenic shock hypoperfusion);
- cardiotoxicity prophylaxis at cytostatic administration;
- disease and conditions, accompanied by loss of appetite and food reflexes, decrease of body
weight, attenuation in children and adults (neurogenic anorexia, mental disorders, dyscirculatory
and traumatic encephalopathy; chronic subacid gastritis, chronic pancreatitis with exocrine
insufficiency; decubation after severe diseases and surgical interventions; prematurity, birth
trauma, respiratory distress syndrome of the newborn; syndrome complex, similar to the Reye's
syndrome (hypoglycemia, hyperketonaemia, coma), developed in children against valporic acid
administration; growth delay and decreased body mass index in children and adolescents under
16 years);
- mild form of thyrotoxicosis in children and adolescents under 16 years;
- in complex therapy of skin diseases (psoriasis, seborrheic eczema, circumscribed scleroderma
and discoid lupus erythematosus);
- long-term intensive training or other high training loads (as anabolic and adaptogene).
POSOLOGY AND METHOD OF ADMINISTRATION
Only for oral administration.
L-Viava could be administered directly or dissolved in water or fruit juice. The drug should be
administered at regular intervals 2-4 times a day, without regard to timing of food ingestion.
To adults and children over 12 years it is prescribed in the doses of 2-6 g a day.
The recommended dose of L-Viava for 50 kg of body weight is 1 g 2-3 times a day. The initial
dose of L-Viava is 50 mg/kg a day, which is divided in 2-3 parts. Later the dose could be
increased on the base of the therapeutic response and tolerability of the drug, including a
physical activity during the therapy.
To children under 12 years and neonates: 50-100 mg/kg a day, but not more than 3 g a day.
In primary and secondary carnitine deficiency the dose depends on an inborn error of
metabolism and a degree of manifestations in the period of the therapy. In the majority of cases
the recommended oral dose is 100-200 mg/kg a day divided in 2-4 parts. If clinical and
biochemical values do not improve, the dose could be increased for a short time.
In acute metabolic decompensation the drug is prescribed in high doses - 400 mg/kg a day.
In carnitine deficiency in hemodialysis patients, the drug is prescribed for oral administration in
the dose of 1 g a day. In the day of hemodialysis the drug is administered after hemodialysis
session.
It is prescribed to adults with a syndrome of anorexia nervosa, as well as in the period of
recovery after past disease and surgical interventions in the dose of 2 g 2 times a day. Duration
of use: 1-2 months.
In long-term physical activity - 1-2 g 2-3 times a day.
For appetite stimulation and increasing of body weight patients with chronic subacid gastritis
and chronic pancreatitis with exocrine insufficiency the drug is prescribed as a single dose - 500
mg 2 times a day. Duration of use: 1-1.5 months.
In the therapy of skin diseases a single dose of the drug is 1 g 2 times a day. Duration of use: 2-4
weeks.
In growth delay and hyperthyroidism – the single dose of the drug is 250 mg 2-3 times a day for
20 days. The course of treatment should be repeated after the 1-2 months break or it should be
used for 3 months without a break.
In cerebral affections of vascular, toxic and traumatic genesis – 0.5-1 g a day for 3-5 days. If
necessary the course of treatment is repeated after 12-14 days.
The treatment duration is 1 - 12 months. If necessary the life-long therapy is carried out. The
monitoring should include periodic carrying out of biochemical blood assay, evaluation of vital
signs, establishing of carnitine concentration in plasma and evaluation of general clinical state. It
is recommended to control the therapy, measuring the concentrations of free and acyl
levocarnitine in plasma and in urine for appropriate dose determination. The carnitine plasma
concentration is 35-60 μmol/l. The free and acyl levocarnitine correlation in plasma normally is
0.35.
CONTRAINDICATIONS
- hypersensitivity to the drug components.
ADVERSE REACTIONS
Digestive system: pain in the upper abdomen, dyspepsia.
Other: a specific body odor, seizures and increase of their frequency in patients with a history of
convulsive disorder.
SPECIAL INDICATIONS
The administration of L-Viava in patients with diabetes mellitus may lead to the development of
hypoglycemia as a result of improvement in glucose uptake. Therefore, blood glucose level
should be regularly monitored and where it is necessary to carry out the dosage adjustment of
hypoglycemic drugs and insulin.
THE INFLUENCE ON THE ABILITY TO DRIVE AND TO OPERATE MECHANISMS
Drug doesn’t influence on the ability to drive or operate with mechanisms.
APPLICATION DURING PREGNANCY AND LACTATION
L-Viava can be administered during pregnancy and lactation only if the expected benefit to the
mother is greater than any possible risk to the fetus or infant.
PEDIATRIC USE
The drug can be used in pediatric practice.
INTERACTION WITH OTHER DRUGS
Drug interactions with the drug L-Viava are not described.
OVERDOSAGE
There have been no reports of toxicity from levocarnitine overdosage.
PACKAGE
L-Viava 1 g/10 ml or 2 g/10 ml oral solution
Oral solution in amber glass vial of 10 ml closed with white plastic cap.
10 vials together with a leaflet in a carton box.
STORAGE CONDITIONS
Store at temperature not exceeding 25°C.
Keep out of reach of children!
SHELF-LIFE
4 years from the date of manufacture.
Do not apply after the shelf-life expiration.
SALES TERMS
Sold without prescription.
MANUFACTURER
The holder of trade mark and Marketing Authorization is
“DR SERTUS İLAÇ SANAYİ VE TİCARET LİMİTED ŞİRKETİ”, TURKEY.
Manufactured by
“Abdi İbrahim İlaç San. ve Tic. A.Ş.”, Turkey
(Sanayi Mahallesi, Tunç Caddesi No: 3 Esenyurt 34555 / İstanbul).