Validated by the Department of State Control for Medicaments and Medical Equipment of the Health Ministry of Russia December 24, 2002 Registration number Р. 001962/01-2002

INSTRUCTIONS for medical use

Dosage form

Emulsion for intravenous injection (infusion).

Соmposition

100 ml of emulsion contain: pfocalin (purified perfluorodecalin) - 13 g, pforidin (purified perfluoromethylcyclohexylpiperidin) - 6.5 g, proxanol - 4 g, sodium chloride - 0.6 gг, potassium chloride - 0.039 g, magnesium chloride (calculated on the basis of dry substance) - 0.019 g, baking soda - 0.065 g, monosubstituted sodium phosphate - 0.02 g, glucose - 0.2 g, water for injections - necessary amount to make 100 ml.

Description

After defrosting at room temperature, it represents a transparent emulsion tinged with blue, odorless.

Pharmacotherapeutic group

Blood substitute with a gas-transporting function.

Pharmacological properties

Perftoran is used as an antishock and anti-ischemic agent. The preparation provides for gas-transporting, rheological, hemodynamic, diuretic, membrane-stabilizing, heart-protecting and sorptive effects. The half-life period of perftoran elimination from the blood bed is about 24 hours. The surfactants leave completely the organism via the kidneys within the first day. Perfluorocarbons are chemically inactive and are not metabolized in the body. The terms of their elimination from the body depend on the dose administered. While using perftoran at a therapeutic dose of 10 ml/kg of body weight, the perfluorocarbons are completely eliminated from the body within 8 months.

Indications for use

Perftoran is recommended for use as a blood substitute with a gas-transporting function in the cases as follows:

Contraindications

Perftoran is contraindicated in cases of hemophilia.

Particular indications

In the periods of pregnancy and breast-feeding, the preparation can be used only in cases of vital necessity.

Precautions

The preparation is unsuitable for use in the cases as follows:

1. Emulsion stratification (the presence of transparent oily spots settling at the bottom even after shaking up);

2. Appearance of a white sediment at the bottom of the flask.

It is prohibited to:

1. Shake vigorously the defrosted preparation;

2. Defrost the preparation at a temperature higher than +30 С;

3. Store it at temperatures below -18 С.

Administration and dosage

Before infusing perftoran, the physician should visually examine the preparation. This one is considered as suitable for use if no cracks are observed on the bottle, if the package has been kept airtight and the label is in place. The results of the visual examination of the bottles and of the data given on the bottle label (name of the preparation, manufacturer, series number) are registered in the case record.

When administering perftoran, it is obligatory to perform a biological test: after infusing slowly 5 first drops of the preparation, then the infusion is suspended for 3 minutes, after that 30 more drops are infused and the infusion is stopped another time for 3 minutes. If no reaction is observed, the preparation infusion is going on. The results of the biological test are obligatory to register in the case record.

Treatment of severe blood loss and of a shock Perftoran is infused intravenously by drops or jets with a dose of 5 to 30 ml/kg of body weight. The effect of the preparation is enhanced if the patient breathes, during its infusion and for 24 hours after infusion, with a mixture enriched with oxygen.

For treating microcirculation disorders of various origin, the preparation should be infused with a dose of 5 to 8 ml/kg of body weight. New infusions of the preparation can be carried out with the same dose three times at 2-4 days intervals. To enhance the oxygenating effect during the treatment, it is recommended to supply an air mixture enriched with oxygen through a mask or a nasal catheter.

For anti-ischemic protection of donor organs, pеrftoran is infused to the donor and to the donee by drops or by jets with a dose of 20 ml/kg of body weight, 2 hours before the operation.

Regional administration Pеrftoran is used for perfusion of the extremities, a standard oxygenator being filled at a rate of 40 ml/kg of body weight.

For local application, pеrftoran is used in a similar way like in case of traditional means of medicamental therapy.

Adverse reactions

The injection of perftoran can cause allergic reactions (urticaria, skin itch, skin reddening), tachicardia, decrease of arterial pressure, body temperature rising, headache, retrosternal pain and lumbago, labored breathing, anaphylactoid reactions. If such reactions or any complications occur, the infusion should be stopped immediately, and desensitizing, cardiotonic, glucocorticosteroid, vasopressor and other drugs used in anaphylactic shock therapy should be injected without taking out the needle from the vein.

Interaction with other medicaments

It is prohibited to use the preparation together (in the same syringe, system, heart-lung apparatus) with dextranes, polyglukin, rheopolyglukin or hydroxyethyl starch. If necessary, said solutions should be injected into another vein or into the same, after completing the infusion of perftoran.

Presentation

Glass bottles containing 50, 100, 200 and 400 ml, sealed with rubber stoppers squeezed with aluminum caps.

Storage conditions

The preparation should be stored frozen at temperature between -4 С and -18 С. While defrosted, the preparation can be stored in a refrigerator at temperature of +4 С for at most 2 weeks. It is recommended to defrost perftoran at room temperature. After defrosting the preparation should be shaken up carefully until getting full homogeneity of the emulsion, and before infusing it should be heated to +21 - +23 С.

5-fold defrosting/freezing is allowed.

Shell life

3 years at temperatures between -4 С and -18 С; 2 weeks at temperature of +4 С.

Conditions of distribution by drug-stores

Only for use in hospital patients.

Infusion-transfusion therapy at acute massive blood loss (body massa 70 kg)

Producer

"PERFTORAN", Оpen Joint Stock Company, Research and Production Firm 142290, Pushchino, Moscow region, ITEB RAS, "Artificial Blood" building.

Phone: 7(4967) 73-39-82, Phone/Fax 7(4967) 33-05-46