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FDP Medlac liofil 5g of powder. for solution for intravenous inektsiis sol.




The instruction for medical use

of FDP Medlac medicine

the Trade
name FDP Medlac

the International unlicensed

name Fosfruktoza Lekarstvennaya a form
the Powder lyophilized for preparation of solution for intravenous administration, 5 g complete with solvent.

The structure
One bottle of drug contains
active agent – fruktozo-1.6-diphosphate of trinatriyevy salt of trihydrate of 5 g (it is equivalent to fruktozo-1.6-diphosphoric acid of trihydrate of 3.75 g).
One bottle of solvent
water for injections contains 50 ml.

Powder of white or almost white color.

Pharmacotherapeutic group
Drugs for treatment of heart diseases.
Other drugs for treatment of heart diseases. Other cardiotonic drugs. Fructose 1.6 – diphosphate.
The ATX C01EB07 code

the Pharmacological

Pharmacokinetics Concentration properties of a fosfruktoza in plasma, measured in 5 minutes after infusion in a dose of 250 mg/kg, made 770 mg/l. In 80 minutes after the end of infusion of a fosfruktoz it was not found in the defined quantities. Fosfruktoza disappears from plasma thanks to distribution to fabrics of the extravasated course and hydrolysis to inorganic phosphate and fructose under the influence of erythrocyte and plasmatic phosphatases.
A pharmacodynamics
the Main mechanism of effect of drug – the increase in an intracellular high-energy phosphatic pool connected with stimulation of activity of a fosfofruktokinaza, pyruvatekinase and lactatekinase. Intracellular concentration varies depending on cell type. Concentration of a fosfruktoza in human erythrocytes makes 6-10 mg/l of cells.
Interaction with a surface of a cell is shown also in the form of the strengthened diffusion of potassium ions in a cell. FDP Medlac counteracts negative consequences of a hyperpotassemia, interferes with decrease in reserves of adenosine triphosphate in a cardiac muscle and supports warm activity, warning her a stop.
Supporting reserves of ATP and creatine phosphate in ischemia of a myocardium, FDP Medlac promotes cardiorespiratory resuscitation, limits the necrosis zone caused by sharp occlusion of coronary arteries when assigning to patients with an extensive myocardial infarction, especially at an early stage causes favorable cardiocirculator effect and improves a hemodynamics.
FDP Medlac shows protective activity at hemorrhagic and traumatic shocks. FDP Medlac has protective effect on brain tissue, reducing consequences of a hypoxemic stress.
At patients with chronic coronary heart disease of FDP Medlac improves working capacity and function of heart at loading, reduces biochemical and electrocardiographic manifestations of toxic action of tsitostatik on heart. FDP Medlac accelerates restoration of sufficient warm activity after a long ischemic cardioplegia.
FDP Medlac protects a liver and kidneys from ischemia and from the functional and organic damage caused by post-ischemic reperfusion.
FDP Medlac improves rheological indicators of blood at the patients having a disease of peripheral blood vessels. At repeated blood transfusions of FDP Medlac increases an intra erythrocyte energy pool, reduces potassium concentration in the poured plasma, restores a normal ratio of potassium and sodium in cells, improves elasticity and hemolytic resistance of erythrocytes.
At treatment respiratory a distress syndrome at adults, FDP Medlac promotes weakening of small macrovascular damages by oppression of release of a histamine from mast cells and prevention of education of free oxygen radicals in neutrophils.
FDP Medlac positively affects nitrogenous balance and promotes utilization of glucose at the general parenteral nutrition.

– a hypophosphatemia

the Route of administration and doses
of FDP Medlac is intended only for intravenous injection.
For fast intravenous injection (with a speed to 1g/mines that corresponds to speed up to 10 ml/min.) 5 g of FDP Medlac part 50 ml of the enclosed solvent for receiving 10% of solution. The recommended daily doses and duration of treatment are defined by weight of a state. At acute conditions the drug is usually administered at the rate of 70-160 mg/kg (corresponds to 2 bottles a day). In need of introduction of higher doses it is recommended to divide the general daily dose into 2 introductions.
The appointed amount of drug depends on expressiveness of a hypophosphatemia.

The prepared solution has to be transparent, colourless or light yellow, not have foreign particles. To use solution at once, after preparation.
The prepared solution can be used only once. Any, remained after use, the amount of drug should not be used.

Side effects
Very seldom
– a hyperphosphatemia (at unbalanced doses)
– allergic reactions of various degrees of severity to an acute anaphylaxis
Are possible
– feeling of inflow, a pulsation, goosebumps in extremities, numbness of extremities (in case of injection with a speed is higher 10ml/min.)
– morbidity together of introduction, irritation of skin, fibrinferment, phlebitis (at an ekstravazation), feverish reactions, infection of the place of an injection

of the Contraindication
– the known hypersensitivity to drug
– a hyperphosphatemia
– a renal failure
– hereditary intolerance of fructose
– children’s and teenage age up to 18 years (the efficiency and safety are not established)
– pregnancy and the period of a lactation (in view of lack of data on safety and efficiency)

Medicinal interactions
Interaction of a fosfruktoza with other medicines is not recorded.
Compatibility: it is not necessary to combine a fosfruktoza with other drugs, not soluble at rn between 3.5 and 5.8 and also with alkaline solutions of salts of calcium. Not to mix with other solutions.

Special instructions
At patients with clearance of creatinine lower than 50 ml/min. should be watched constantly the level of phosphates in blood, at emergence of signs of a hyperphosphatemia, the drug dose decline is recommended.
It is necessary to control the level of electrolytes in plasma during treatment.
Features of influence on ability to run the vehicle or potentially dangerous mechanisms:
It is necessary to be careful when driving or potentially dangerous mechanisms.

Cases of overdose are not known.
Symptoms: a sharp lowering of arterial pressure and a renal failure, decrease in level of calcium in blood.
Treatment: symptomatic. In hard cases – a hemodialysis.

A form of release and packing
On 5 g of drug in a bottle of colourless II glass the volume of 100 ml corked by rubber bungs and which are pressed out by aluminum caps with a ring of flip-off.
On 50 ml of solvent in the bottles of colourless II glass corked by rubber bungs and which are pressed out by aluminum caps with a ring of flip-off.
On 1 bottle with drug, to 1 bottle with solvent complete with a system for intravenous administration in a sterile plastic bag, together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.

To Store storage conditions at a temperature not higher than 250 Pages.
Not to use drug at the damaged packing.
To store out of children’s reach!

Period of storage
3 years.
The restored solution is used right after preparation.
The expiration date is valid only at appropriate storage.
After an expiration date not to apply!

Prescription status
According to the prescription.

Producer Medlac Pharma Italy Co., Ltd, Vietnam, Hanoi, Tkhan Long, 29

Name and country of the owner of the registration certificate of Medlac Pharma Italy Co., Ltd, Vietnam, Hanoi, Tkhan Long, 29

Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Representative office of Medexport Italy Consortium, Almaty, Ayteke bi, 88
Phone number: +7 727 279 99 00
E-mail address:

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