Universal reference book for medicines
Product name: CERNEVIT (CERNEVIT)

Active substance: comb.
drug
Type: Vitamins for addition to solutions for parenteral nutrition

Manufacturer: BAXTER (Belgium) manufactured by PIERRE FABRE MEDICAMENT PRODUCTION (France)
Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intravenous administration
in the form of a loose solid mass of yellow-orange color, odorless.

1 f.

retinol palmitate (Vitamin A) 3500 IU

-tocopherol (vit E) 11.2 IU,

which corresponds to the content of D, L -? - tocopherol 10.2 mg

Colcalciferol (Vit. D 3 ) 220 IU

ascorbic acid (Vit. C) 125 mg

co-carboxylase tetrahydrate 5.8 mg

which corresponds to the content of thiamine (vit B 1 ) 3.51 mg

riboflavin sodium phosphate dihydrate 5.67 mg,

which corresponds to the content of riboflavin (Vit B 2 ) 4.14 mg

dexpanthenol 16.15 mg,

which corresponds to the content of pantothenic acid (Vit B 5 ) 17.25 mg

pyridoxine hydrochloride 5.5 mg,

which corresponds to the content of pyridoxine (Vit B 6 ) 4.53 mg

Folic acid (Vit B 9 ) 414 μg

cyanocobalamin (Vit B 12 ) 6 μg

nicotinamide (Vit. PP) 46 mg

Biotin (Vit. H) 69 μg

Excipients: glycine 250 mg, glycocholic acid 140 mg, soy bean phosphatides (soy lecithin) 112.5 mg, sodium hydroxide to pH 5.9, hydrochloric acid to pH 5.9.

747 mg - bottles of dark glass (10) - plastic contoured pallets (1) - cardboard boxes.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Zernevit is a balanced mixture of water-soluble and fat-soluble vitamins.
Provides a full-fledged supply of the body with vitamins when carrying out parenteral nutrition.
Pharmacodynamic properties are determined by the properties of the constituent vitamins.

Vitamin A is involved in the growth and differentiation of cells, as well as in the physiological mechanisms of vision.

Vitamin D 3 regulates the processes of calcium and phosphorus metabolism in bones and kidneys.

Vitamin E - an antioxidant, prevents the formation of toxic oxidation products, protects the cellular components.

Vitamin B 1 (thiamine) interacts with ATP to form a coenzyme involved in the metabolism of carbohydrates.

Vitamin B 2 (riboflavin) as a coenzyme takes part in energy metabolism of cells, tissue respiration and metabolism of macroelements.

Vitamin B 3 (PP) as a component of NAD and NADP coenzymes is involved in the oxidation-reduction processes necessary for the exchange of macroelements and tissue respiration.

Vitamin B 5 (pantothenic acid) is a precursor of coenzyme A, associated with the oxidative metabolism of carbohydrates, gluconeogenesis, the synthesis of fatty acids, sterols, steroid hormones and porphyrins.

Vitamin B 6 (pyridoxine) as a coenzyme is involved in the metabolism of proteins, carbohydrates and fats.

Vitamin B 12 (cyanocobalamin) - of exogenous origin, is necessary for the synthesis of nucleoproteins and myelin, cell multiplication, normal growth and maintenance of normal erythropoiesis.

Vitamin C (ascorbic acid) - an antioxidant, is necessary for the formation and maintenance of intercellular substance and collagen, the biosynthesis of catecholamine, the synthesis of carnitine and steroids, the metabolism of folic acid and tyrosine.

Folic acid - exogenous origin, is necessary for the synthesis of nucleoproteins and maintenance of normal erythropoiesis.

Biotin is associated, at least with four enzymes, involved in energy metabolism (including gluconeogenesis).

PHARMACOKINETICS

In patients receiving Carnevit, the concentrations of vitamin A, D, E in plasma are restored and maintained at a normal level during the period of prolonged parenteral nutrition.

Pharmacokinetic properties are determined by the properties of the constituent vitamins:

- vitamin A - a normal serum level of 80-300 IU / ml, bound to a protein, is excreted mostly by the kidneys and with bile;

- vitamin D - is activated in the liver and kidneys by hydroxylation, is bound to the protein, is excreted mainly by the kidneys and with bile;

- vitamin E - gets into the blood with lipoproteins, is converted into a lactone in the liver, is excreted mainly by the kidneys;

- vitamin B 1 (thiamine) - 90% is concentrated in erythrocytes, in plasma it is mainly associated with albumin, it is excreted mainly by the kidneys;

- vitamin B 2 (riboflavin) - in the plasma binds to proteins, the level of vitamin in the plasma can vary greatly, it is excreted mainly by the kidneys in unbound form or in the form of metabolites;

- vitamin B 3 (PP) - in plasma exists in the form of acid and amide, is excreted by the kidneys in unbound form or in the form of metabolites;

- vitamin B 5 (pantothenic acid) - exists in unbound form or in the form of vitamin A in plasma and erythrocytes, excreted by the kidneys;

- vitamin B 6 (pyridoxine) - is metabolized in the liver and excreted by the kidneys;

- vitamin B 12 (cyanocobalamin) - a normal level in the serum of 200-900 pg / ml, binds to proteins, accumulates in the liver, is found in milk, 50-90% is excreted by the kidneys;

- vitamin C (ascorbic acid) - at normal concentrations (8-14 mg / l) is completely absorbed in the kidneys, the excess is excreted by the kidneys;

- folic acid - normal plasma concentrations of 0.005-0.015 μg / ml, distributed to all tissues, metabolized and accumulated in the liver, at high levels the maximum renal reabsorption prevails, is excreted by the kidneys;

- biotin - in the plasma exists in a free form or form, associated with proteins, is excreted by the kidneys mainly in unchanged form.

INDICATIONS

- addition to parenteral nutrition for the prevention of hypo- and avitaminosis for adults and children over 11 years of age.

DOSING MODE

The drug is only for IV administration.

The recommended dose is 5 ml (1 bottle) / day.

Carnevit can be used during the entire period of parenteral nutrition.
Duration of use - in accordance with the appointment of a doctor.
Rules for the preparation and administration of a solution

Using a syringe, 5 ml of water for injection or 5% dextrose (glucose) solution, or 0.9% sodium chloride solution, is injected into the vial.
Gently stir until the lyophilizate is completely dissolved. The resulting solution has a yellow-orange color.
The resulting solution is slowly introduced into / in a stream (for at least 10 minutes).

The drug solution can be added to two-component (glucose solution with electrolytes and amino acids) or three-component (glucose solution with electrolytes, amino acids, fat emulsion) solutions for parenteral nutrition, provided compatibility.

Before use, check the integrity of the package.

Observance of aseptic conditions is necessary.

Do not store the vial with unused remnants of the drug or with a preparation whose color after dissolution does not correspond to the description.

SIDE EFFECT

Allergic reactions: since the drug contains vitamin B 1 , rarely (> 1/10 000 - <1/1000), anaphylactic reactions develop in patients with delayed-type allergy.

The patient should inform the doctor of any emerging side effects.

CONTRAINDICATIONS

- children's age till 11 years;

- Hypersensitivity to the components of the drug, especially to vitamin B 1 .

Relative contraindication: simultaneous administration of levodopa.

PREGNANCY AND LACTATION

Since the data of clinical studies on the use of the drug Zernevit in pregnant women are absent, the drug should not be administered during pregnancy.

The use of the drug during lactation is not recommended, since vitamins are excreted in breast milk.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Because of the presence of glycocholic acid as an adjuvant, with repeated and prolonged administration of the drug in patients with jaundice or severe cholestasis (changes in laboratory functional tests of the liver), liver function should be carefully monitored.

APPLICATION FOR CHILDREN

Contraindication: children under 11 years.

SPECIAL INSTRUCTIONS

Because of the presence of glycocholic acid as an adjuvant, with repeated and prolonged administration of the drug in patients with jaundice or severe cholestasis (changes in laboratory functional tests of the liver), liver function should be carefully monitored.

Deficiency of one or more vitamins should be corrected by the introduction of the drug of the missing vitamin.

Carnevit does not contain vitamin K, which, if necessary, can be administered separately.

After dilution, the preparation is stable at a temperature of no higher than 25 ° C for 24 hours, but the drug is recommended to be used immediately after dilution or stored for no longer than 24 hours at a temperature of 2 ° to 8 ° C.

Impact on the ability to drive vehicles and manage mechanisms

Since Carnevit is intended for patients receiving parenteral nutrition and who are in a severe and moderate condition, the ability to drive and operate machinery has not been evaluated.

OVERDOSE

Overdose is mainly caused by excessive doses of vitamin A.

Symptoms: with acute overdose of vitamin A (doses exceeding 150 000 ME) - gastrointestinal disorders, headache, increased intracranial pressure, edema of the optic nerve, mental disorders, excitability, sometimes convulsions, delayed generalized desquamation of the epithelium;
with a chronic overdose of vitamin A - increased intracranial pressure, cortical hyperostosis and premature infection of the epiphyseal plate, which is usually expressed in the occurrence of sensitive or painful subcutaneous edema on the fingers of the upper and lower extremities. Radiographic examination of elbows, peroneum, clavicles and costal bones reveals diaphyseal periosteal thickening.
Treatment: stop the use of the drug, reduce the use of calcium, increase diuresis and conduct adequate rehydration of the body.

DRUG INTERACTION

Due to the presence of pyridoxine (vitamin B 6 ) in the formulation, the combined use of levodopa with drugs is contraindicated due to the acceleration of the metabolism of levodopa with the participation of a pyridoxine-dependent enzyme.
To prevent this interaction, an inhibitor of dopa decarboxylase, carbidopa, can be used.
Due to the presence of folic acid in the formulation, caution should be exercised when combined with antiepileptic drugs containing phenobarbital, phenytoin or primidone.
Clinical observation and, if possible, monitoring the content of antiepileptic drugs in blood plasma, correction of the dosage regimen of the antiepileptic drug during and after the termination of the use of folic acid is necessary.
Compatibility in preparation with other infusion solutions should be checked, especially if Cernevit is added to binary parenteral mixtures containing glucose, electrolytes and amino acid solutions or to mixtures containing glucose, electrolytes, amino acid solutions and lipids.

The patient should inform the doctor of any medications that have been used previously.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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