Composition, form of production and packaging
Solution for infusions of dark red color, without sediment and suspension.
hemoglobin glutamer-250 (bovine) 13 g
Excipients: sodium 154 mmol / l, acetylcysteine вЂ‹вЂ‹0.2 g / dL (antioxidant), water d / and up to 250 ml.
chloride 111 mmol / l, potassium 4.1 mmol / l, calcium 1.1 mmol / l, lactate 27 mmol / l (buffer solution),
250 ml - packets (1) infusion - packings of aluminum foil, polyethylene coated gas-tight, protective.
250 ml - packages (1) infusion - packages made of aluminum foil coated with polyethylene (5) gas-tight, protective - cardboard boxes.
250 ml - packages (1) infusion - packages from aluminum foil coated with polyethylene (10) gas-tight, protective - cardboard boxes.
250 ml - bags (1) infusion - packages of aluminum foil covered with polyethylene (15) gas-tight, protective - cardboard boxes.
250 ml - packages (1) infusion - packages of aluminum foil coated with polyethylene (25) gas-tight, protective - cardboard boxes.
250 ml - packages (1) infusion - packages made of aluminum foil coated with polyethylene (30) gas-tight, protective - cardboard boxes.
250 ml - packages (1) infusion - packages made of aluminum foil coated with polyethylene (55) gas-tight, protective - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
HEMOPYRВ® is an oxygen-transporting fluid (hemoglobin-associated oxygen carrier), which increases the concentration of both total and plasma hemoglobin and provides oxygen delivery to tissues and organs.
The action of HEMOPYRВ® is related to its most important pharmacological property, namely, the ability to increase the delivery of oxygen to tissues. HEMOPYRВ® binds oxygen in the lungs and gives it to tissues more efficiently than hemoglobin of erythrocytes, due to the high value of P50 (partial oxygen tension at which the saturation level of hemoglobin with oxygen is 50%). The relationship between the partial oxygen tension and the oxygen saturation of blood is graphically expressed as a dissociation curve of oxyhemoglobin (SOD) having an S-shaped shape, this form of BWW corresponds to the optimal conditions of oxygen saturation in the lungs and the release of oxygen from the blood in the tissues. The P50 is normal for blood at 27 mm Hg, it determines the affinity of hemoglobin for oxygen: the higher the P50 (ie, there are fewer places on the hemoglobin molecules for oxygen binding), the lower the affinity of hemoglobin for oxygen, but more ability to give oxygen in tissues. Under physiological conditions, when pH decreases (tissue hypoxia), P50 increases, the affinity of hemoglobin for oxygen decreases (Bohr effect), which improves the oxygen release at tissue level. For the drug HEMOPYRВ® P50 is 40 mmHg. which provides a shift in the oxygen dissociation curve to the right (indicating a decrease in the interaction of hemoglobin and oxygen), while oxygen release at tissue level becomes more effective. Provided that all hemoglobin hemoglobin molecules of HEMOPURВ® are completely saturated with oxygen, approximately 1.36 ml of oxygen per 1 g of hemoglobin (as well as for human hemoglobin) is achieved.
The oxygen content in the arterial blood of 200 ml / l is sufficient to meet the needs of tissues in oxygen.
When the concentration of free hemoglobin in the plasma? 0.6 g of hemoglobin per kg of body weight (concentration of total plasma hemoglobin is 45 g), an increase in oxygen content in the arterial bed by more than 20% and an increase in the diffusion volume of oxygen through the alveolar capillary membrane of the lungs in comparison with the norm by 10-15%.
HEMOPYRВ® provides a gas transport function instead of red blood cells in patients with anemia, providing sufficient oxygenation of blood, which allows to delay or completely eliminate the need for transfusion of erythrocyte mass. In clinical studies, it has been proven that transfusion of HEMOPYRВ® stimulates the formation of the body's own red blood cells within 7-14 days, resulting in the absence of the need for erythrocyte mass.
The drug HEMOPYRВ® is able to penetrate into narrowed or partially blocked vessels, improving the oxygenation of ischemic tissues. HEMOPYRВ® has a viscosity of 1.3 centipoise, about 1/3 of the viscosity of the blood, so adding HEMOPYRВ® to the blood reduces the total viscosity of the blood. It also helps improve blood flow and rheology.
T 1/2 of the drug is from 18 to 24 hours. Removal of the drug occurs in the reticuloendothelial system (RES). The clearance is 0.12 l / h. C max hemoglobin in plasma is proportional to the dose of the drug. GEMOPYRВ® is characterized by linear pharmacokinetics (within 0.6 and 2.5 g / kg). V d corresponds to the volume of the plasma.
The drug HEMOPYRВ® is used for the following indications:
- Treatment of acute anemia of any etiology, including with planned and emergency surgical operations;
- the need to reduce, delay or completely eliminate the need for transfusion of erythrocyte mass;
- treatment of tissue hypoxia of various ethnologies (ischemia of organs and tissues, acute blood loss);
- use in the absence of the possibility of transfusion of erythrocyte mass;
- use in complex therapy in the treatment of anemia with chemotherapy.
Indications for the beginning of the transfusion of the drug is the presence of one or more signs of anemia:
- heart rate ? 100 beats per minute;
- systolic blood pressure <90 mm Hg. st or <70% preoperative;
- hemoglobin less than 100 g / l;
- Acute blood loss more than 7 ml / kg for 2 hours or less;
- oliguria, diuresis less than 5 ml / kg / h for at least 2 h.
The drug should be administered iv. One dose of the drug - 250 ml (1 infusion pack).
Permanent oxygenation is established at the initial transfusion of the dose of saturation - 500 ml of the drug (2 doses), followed by periodic administration of 250-500 ml (1-2 doses.) Per day. After the first transfusion, if the patient retains clinical signs and signs of anemia, additional doses of the drug may be administered to the patient, up to a maximum of 7 doses within 6 days. In clinical trials, most patients needed less than 6 doses of the drug to eliminate clinical symptoms of anemia. The decision on transfusion of repeated doses of the drug should be based not on the indicator of hemoglobin, but on the clinical symptoms of anemia.
Table 1. Principle of dosing:
If hemoglobin 60-100 g / l (hematocrit 18-30%) Pour one dose (250 ml - 32.5 g of hemoglobin) to increase hemoglobin more than 100 g / l. With the stabilization of the clinical picture in the patient, and there are no signs of continuing anemia, there is no need for a second dose in the transfusion. If the hemoglobin value remains below 70 g / l, it is recommended to pour another dose within 24 hours (remember that T 1/2 HEMOPYRВ® is 18-24 h).
If hemoglobin is less than 60 g / l, then immediately pour 2 doses of the drug.
It is necessary to monitor the hemoglobin index every 24 hours after the start of the first dose and one hour after the end of each dose transfusion. Before the beginning of the transfusion of HEMOPYRВ®, once during the procedure, and every 3 hours after it, it is necessary to control the gas composition of the blood (saturation of the arterial blood with oxygen). After 72 hours, the effect of activation of the body's own red blood cells begins (up to 7-14 days maximum), the use of HEMOPYRВ® can be canceled.
Principles of monitoring:
- Blood pressure (BP) (constantly)
- Saturation by pulse oximer (constantly)
- Hemoglobin (1 hour after each dose, every 24 hours after the start of the transfusion of the first dose)
- Saturation of oxygen in the arterial blood before the procedure, during and every 3 hours after it.
The drug is usually administered at a rate of 1-2 ml / min. If necessary, depending on the patient's condition, the rate of administration can be increased. With the initial administration of HEMOPYRВ® in patients with a clinically significant increase in blood pressure, it is recommended to establish nitroglycerin infusion in minimal doses. In future, calcium channel blockers, beta-blockers are recommended for the regulation of blood pressure with a clinically significant increase in blood pressure.
Table 2. Principle of dosing
Stable state The transfusion rate is 1-2 ml / min, which corresponds to the transfusion time of one dose in 2-4 hours.
Unstable state, pronounced hypovolemia You can pour the entire dose of 90-120 ml
The clinical response is a decrease in heart rate, an increase in the blood pressure of blood pressure should appear with the transfusion of the first 50-100 ml of the drug.
Technique of transfusion:
- The solution must have a pure, rich ruby вЂ‹вЂ‹color before use, if the solution is brown, it means methhemoglobin was formed and it can not be used;
- The outer packaging should be removed before use, in open form the drug should be used within 24 hours;
- HEMOPYRВ® before administration does not require a cross-sample for compatibility with the patient's blood;
- HEMOPYRВ® is introduced in compliance with all the conditions of aseptic and antiseptic, using the standard set for I / O access;
- route of administration - central or peripheral venous access;
- should be inserted into a separate infusion catheter, so that there is no mixing with other infusion solutions;
- do not add other medicines to the solution;
- do not mix the contents of the two packages of the drug;
- there is no need to use infusion filters.
Table 3. Can be expected during transfusion:
Manifestations of Action
Increase in systolic blood pressure by an average of 20 mm Hg. Art. - Reduce the infusion rate - If the increase in blood pressure is clinically significant, you can use blockers of "slow" calcium channels or small doses of IV infusion of nitrates
Hiccough, chest pain, esophageal and intestinal spasm. - Reduce the infusion rate - Small doses of atropine 0.2-0.5 mg. This effect is less pronounced in the case of repeated blood transfusion. regulates NO
Reduction of hemoglobin and hematocrit, which is a manifestation of hemodilution Repeat blood test for hemoglobin and hematocrit every 24 hours, if necessary, pour another dose
Decrease in saturation due to pulse oximetry data during transfusion (hemoglobin dissociation curve) Control arterial blood saturation
If other colloids are simultaneously poured, liquid volume may be reloaded with appropriate clinical manifestations up to pulmonary edema. Treatment is symptomatic
Blood transfusion is not contraindicated for patients receiving the drug HEMOPYRВ®.
- short-term reversible gastrointestinal disturbances (dysphagia, nausea, vomiting, dyspepsia, diarrhea, intestinal spasm);
- Increased blood pressure by 15-20 mm Hg, headache;
- allergic reactions;
- yellowing of the skin, sclera;
- a short-term increase in "liver" transaminases and pancreatic enzymes: aspartate aminotransferase, alanine aminotransferase, lipase.
The appearance of yellowness of the skin and the sclera of the eyes is a consequence of the natural utilization of hemoglobin in the transition of hemoglobin to bilirubin and is not associated with clinical liver dysfunction.
Transient increase in the level of enzymes in the blood is not associated with clinical damage to the liver or pancreas.
If an allergic reaction develops during the transfusion of the drug, stop the infusion and perform symptomatic treatment immediately.
HEMOPYRВ® is contraindicated in patients older than 80 years, patients with increased sensitivity to bovine hemoglobin and patients with systemic mastocytosis.
Contraindication to transfusion is uncontrolled arterial hypertension.
Carefully. The safety of the drug in children (under 18 years), pregnant and lactating women is not confirmed. Due to the lack of accurate clinical data, the drug should be used with caution in these patient groups, after a thorough balance of benefit and risk.
PREGNANCY AND LACTATION
The safety of the drug in pregnant and lactating women is not confirmed. Due to the lack of accurate clinical data, the drug should be used with caution, after careful correlation of benefit and risk.
APPLICATION FOR CHILDREN
The safety of the drug in children (under 18 years) is not confirmed. Due to the lack of accurate clinical data, the drug should be taken with caution, after careful correlation of benefit and risk.
APPLICATION IN ELDERLY PATIENTS
Contraindicated in patients older than 80 years.
When transfusing the drug, it should be noted that it is an isononic colloidal solution. It should be used with caution in conjunction with other colloids, in order to avoid circulatory overload.
Samples of serum and blood plasma in patients who received an infusion of the drug HEMOPYRВ® are red colored due to hemoglobin, which may not correctly display the results of clinical laboratory tests, depending on the type of analyzer or reagent used. An accurate determination of the concentration of bilirubin or albumin is not possible with the presence of HEMOPYRВ® in plasma or serum.
Cases of overdose during clinical trials of the drug have not been identified.
In patients with concomitant heart failure, the administration of HEMOPYURВ® can cause hypervolemia, especially when other solutions are administered in large volumes . Treatment: symptomatic.
Compatible with donor blood, dextrose solutions, antibiotics, 0.9% sodium chloride solution (NaCl), solutions including electrolytes and not supporting colloid osmotic pressure.
Concomitant administration of other colloidal solutions (such as plasma, hydroxyethyl starch, etc.) must be done with caution to avoid circulatory overload.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Store at temperatures between 2 and 30 В° C. Do not freeze. Use within 24 hours after opening the package. Keep out of the reach of children!
Shelf life. 3 years. Do not use at the expiration date indicated on the package.