Enoxaparin-Binergia, 10 thousand anti-Xa IU/ml, solution for injection, 0.4 ml, 10 pcs.

Indications for use

The kit is used to control the thoroughness of pre-sterilization cleaning of all medical instruments that come into contact with the wound surface, come into contact with blood or injectable drugs (for example, a set of operating instruments).

Azopyram-Kit is used on medical products to detect traces of:

• blood;
• rust;
• washing powder with bleaches;
• acids;
• oxidizing agents (in particular, chrome mixture, bleach, chloramine, etc.);
• peroxidases of plant origin.

Inspections are carried out at disinfection and sanitary-epidemiological stations, as well as in all medical and preventive institutions.

basic information

The azopyram test is an assessment of the quality of disinfection and pre-sterilization treatment. It is carried out before the sterilization procedure for each batch of instruments processed during the day.

The azopyram test allows you to determine whether biological material remains on the instruments - blood, skin particles, biological secretions. The requirement to periodically assess the quality of pre-sterilization cleaning is regulated by SanPiN 2.1.3.2630-10 “Sanitary and epidemiological requirements for institutions engaged in medical activities.”

Disinfection and pre-sterilization cleaning of manicure instruments: how to choose a disinfectant and prepare the solution correctly

Paragraph 2.14 of the document describes how often you need to do an azopyram test and what to do with the results:

• How often should I do an azopyram test? Quality control is carried out daily;
• How many instruments are tested? 1% from each batch of processed instruments, but not less than 3 pcs. If you have to process 20 manicure tools, then you need to take 3 of them for testing;
• What to do with the results? The result is entered into the journal “Accounting for the quality of pre-sterilization treatment”. The correctness and systematic filling of the log is checked by Rospotrebnadzor during scheduled and unscheduled inspections. In this case, only negative results should be recorded in the journal. If positive, disinfection and PSO are repeated to eliminate contamination.

Stages of implementation:

1. Preparation of the solution;
2. Carrying out a test;
3. Analysis of results and recording in the log book.

Safety precautions:

• the procedure should be carried out wearing gloves, goggles and a protective mask. Aniline, one of the components of azomiram liquid, is a toxic substance and can lead to poisoning;
• the room where the azopyram test is carried out is ventilated after the procedure so that toxic substances do not linger in the air.

Directions for use and dosage

To prepare the working composition, you need to transfer aniline hydrochloride (10 ml) into a bottle with amidopyrine solution (90 ml) and mix thoroughly. Immediately before the pre-sterilization test, the solution should be brought to a volume of 200 ml by adding 100 ml of 3% (pharmacy) hydrogen peroxide. The resulting mixture must be thoroughly mixed until completely dissolved and used within 2 hours.

Before starting work, you should conduct a suitability test, for which 2-3 drops of the working solution are applied to the blood stain. If a violet color appears within 1 minute, the reagent is considered suitable for use. If staining does not occur or it appears 1 minute after the test, the result is not taken into account and this solution cannot be used. Monitoring the cleaning of medical instruments before sterilization using Azopyram-Kit is carried out in medical institutions at least once a week . The control process is organized and carried out by the head nurse of the department. Once a quarter, control is carried out by sanitary and epidemiological stations.

The working solution (Azopyram-Kit reagents and 3% hydrogen peroxide in a 1:1 ratio) is applied to the medical instruments and products under study - wiped with a swab or applied directly to the instrument using a pipette. To check syringes (reusable), pour 3-4 drops of the working solution into them and move the piston several times to wet the entire inner surface of the instrument. To assess the quality of cleaning of catheters and other hollow products, a solution is injected into them using a syringe or pipette. The solution is left for 1 minute, after which it is poured onto a gauze napkin. The amount of reagent required to test a product directly depends on its size.

Using one Azopyram-Kit, you can carry out about 2000 reactions, based on the consumption of the working solution: 2 drops per 1 test.

Azopyram (1-fl.-10 g)

Azopyram is a reagent for detecting hidden traces of blood on medical instruments that have been prepared for sterilization. This drug is used to control the thoroughness of pre-sterilization cleaning of all medical instruments that come into contact with the wound surface, come into contact with blood or injectable drugs (for example, a set of operating instruments). In addition to traces of blood, Azopyram is used to detect traces of rust, washing powder with bleaches, and acids on medical products. Trade name "Azopyram-set". The composition of the Azopyram reagent includes amidopyrine 10% (in ethyl alcohol solution), aniline hydrochloride 0.10-0.15%. The Azopyram kit includes a package of reagent 1, reagent 2 in an orange test tube and a white test tube with reagent 3. Using 1 set of Azopyram, you can carry out about 2000 reactions (if the consumption of the working solution is 2 drops per reaction). Application of the Azopyram reagent To prepare 1 liter of solution, 100 g of amidopyrine and 1.0-1.5 g of aniline hydrochloride are required. The solution must be brought to a volume of 1 liter with the addition of 95% ethyl alcohol. The resulting mixture must be thoroughly mixed until completely dissolved. To directly check the quality of cleaning of medical instruments, it is necessary to prepare a working solution by mixing equal parts of Azopyram and a 3% hydrogen peroxide solution. Before use, you should test the suitability of the drug; for this, 2-3 drops of the working solution should be applied to the blood stain. If a violet color appears within 1 minute, the reagent is considered suitable for use. If coloring does not appear, then the solution cannot be used. Coloring that appears 1 minute after the test is not taken into account. Monitoring the cleaning of medical instruments before sterilization using the Azopyram-kit is carried out in medical institutions at least once a week. The control process is organized and carried out by the head nurse of the department. Once a quarter, control is carried out by sanitary and epidemiological stations. Instructions for use of Azopyram The working solution (Azopyram and 3% hydrogen peroxide in a 1:1 ratio) is applied to the medical instruments and products under study - wiped with a swab or applied directly to the instrument using a pipette. To check syringes (reusable), pour 3-4 drops of the working solution into them and move the piston several times to wet the entire inner surface of the instrument. To assess the quality of cleaning of catheters and other hollow products, Azopyram is injected into them using a syringe or pipette. The solution is left for 1 minute, after which it is poured onto a gauze napkin. The amount of reagent required to test a product directly depends on its size. Storage of the drug The instructions for Azopyram state that the shelf life of the prepared solution in a tightly closed dark bottle at a temperature of +4 C (that is, in the refrigerator) is 2 months. If the solution is stored in the dark, but at room temperature, then its shelf life is no more than 1 month. Features of using Azopyram In the case of moderate yellowing of the reagent, Azopyram (without precipitation) does not reduce its quality in any way. When checking medical instruments, they should be at room temperature. Hot products should not be tested, and the solution should not be used near heating devices. The working solution (Azopyram + 3% hydrogen peroxide) should not be kept in bright light and can only be used for 2 hours.

Please check with the seller for detailed information about the product by contacting him at the phone number indicated above or by sending an electronic request through the feedback form.

special instructions

Moderate yellowing of the kit reagents (without precipitation) does not in any way reduce its quality.

When checking medical instruments, they must be at room temperature. Do not test hot products, and do not use the solution near heating devices.

The working solution (Azopyram-Kit reagents + 3% hydrogen peroxide) should not be kept in bright light and can only be used for 2 hours.

The drug is able to retain its properties after freezing and subsequent thawing.

Preparation of the solution

There are two ways to prepare the liquid for the procedure:

• from amidopyrine in the form of a dry powder. For 1 liter of the finished reagent, mix 100 g of amidopyrine in a clean, dry container with 1-1.5 g of aniline hydrochloride. Bring the mixture to 1 liter by adding 95% ethyl alcohol;
• from an azopyram kit, including 2 mixing reagents. To prepare, simply mix the contents of two bottles thoroughly. There is such a kit.

The resulting solution is ready, but not working. To prepare the working fluid, it is necessary to add hydrogen peroxide to azopyram.

1. Measure out an equal amount of prepared azopyram solution and 3% hydrogen peroxide;
2. Mix azopyram and peroxide and you will get a working reagent.

The working solution must be used no later than 60-120 minutes after preparation. After this time, it is unsuitable for work.

For the exact service life of the working fluid, see the instructions for the specific product.

The stores offer different kits and reagents for preparing the solution, including those with letter additives:

• Azopyram-D;
• Azopyram-R;
• Azopyram-SK;
• Azopyram-P;
• Azopyram-K.

Depending on the product you choose, the technology for preparing the finished solution will change slightly, so be sure to study the instructions for the drug. In this case, the evaluation of the solution and the test result do not depend on the manufacturer and kit configuration.

Checking the working solution

If you are not sure whether the prepared liquid can be used, do the test:

1. Apply a few drops of the solution to the blood stain using a pipette;
2. After exactly 1 minute, check the color of the liquid. If it turns out purple-lilac, you can use the product. If a pronounced color does not appear at all, the product is not suitable for use.

In the absence of blood, a performance test can be performed by dropping an azopyram solution onto a drop of detergent. In this case, the suitable liquid will turn pink.

The prepared solution, not diluted with hydrogen peroxide, and poured into a bottle with a tight lid can be stored for no more than 1 month at room temperature and no more than two months at temperatures below +4 degrees. The storage place should be dark.

To control storage conditions, the mixing date is marked on the bottle with the finished liquid.

Shelf life of Azopyram

Different release forms have different shelf life:

• Powder concentrate (Azopyram SK) – stored for 2 years.
• Alcohol solution of reagents (Azopyram Kit) - no longer than 2 months.

How to identify an expired or defective drug?

In the case of a powder product, the defect can only be determined by the damaged packaging, and the product itself remains unchanged. Therefore, you should carefully read the information on the packaging.

The alcohol solution has a characteristic odor. If it is absent, it is difficult to consider the drug spoiled.

What happens to the product over time?

Over time, powdered Azopyram does not change its appearance, but the components lose their properties.

As for the solution, an important change, in addition to the loss of properties, is the absence of odor or its weakening. Occasionally, sediment may appear.

Enoxaparin-Binergia, 10 thousand anti-Xa IU/ml, solution for injection, 0.4 ml, 10 pcs.

Are common

Low molecular weight heparins are not interchangeable, as they differ in the manufacturing process, molecular weight, specific anti-Xa activity, dosage units and dosage regimen, which are associated with differences in their pharmacokinetics and biological activity (antithrombin activity and interaction with platelets). Therefore, it is necessary to strictly follow the recommendations for use for each drug belonging to the class of low molecular weight heparins.

Bleeding

As with the use of other anticoagulants, when administering enoxaparin sodium, bleeding of any location may develop. If bleeding develops, it is necessary to find its source and prescribe appropriate treatment.

Bleeding in elderly patients

When using enoxaparin sodium in prophylactic doses in elderly patients, there was no increase in the risk of bleeding.

When using the drug in therapeutic doses in elderly patients (especially those aged 80 years and older), there is an increased risk of bleeding. Close monitoring of such patients is recommended.

Concomitant use of other drugs that affect hemostasis

It is recommended that the use of drugs that affect hemostasis (salicylates, including acetylsalicylic acid, non-steroidal anti-inflammatory drugs, including ketorolac; dextran with a molecular weight of 40 kDa, ticlopidine, clopidogrel; glucocorticosteroid drugs, thrombolytics, anticoagulants, antiplatelet agents, including glycoprotein IIb receptor antagonists /IIIa), was discontinued before starting treatment with enoxaparin sodium, except in cases where their use is necessary. If combinations of enoxaparin sodium with these drugs are indicated, careful clinical observation and monitoring of relevant laboratory parameters should be carried out.

Kidney failure

In patients with impaired renal function, there is a risk of bleeding as a result of increased systemic exposure to enoxaparin sodium. In patients with severely impaired renal function (creatinine clearance less than 30 ml/min), there is a significant increase in the exposure of enoxaparin sodium, therefore it is recommended to adjust the dose for both prophylactic and therapeutic use of the drug. Although no dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance 30-50 ml/min or 50-80 ml/min), close monitoring of such patients is recommended.

Low body weight

There was an increase in the exposure of enoxaparin sodium when used prophylactically in women weighing less than 45 kg and in men weighing less than 57 kg, which may lead to an increased risk of bleeding. Careful monitoring of the condition of such patients is recommended.

Obese patients

Obese patients have an increased risk of developing thrombosis and embolism. The safety and effectiveness of enoxaparin sodium in prophylactic doses in obese patients (body mass index (BMI) more than 30 kg/m²) has not been fully determined and there is no general consensus on dose adjustment. These patients should be closely monitored for the development of symptoms and signs of thrombosis and embolism.

Monitoring the number of platelets in peripheral blood

The risk of developing antibody-mediated heparin-induced thrombocytopenia also exists with the use of low molecular weight heparins. If thrombocytopenia develops, it is usually detected between 5 and 21 days after initiation of enoxaparin sodium therapy. In this regard, it is recommended to regularly monitor the platelet count in the peripheral blood before starting treatment with enoxaparin sodium and during its use. If there is a confirmed significant decrease in platelet count (by 30-50% compared to the initial value), it is necessary to immediately discontinue enoxaparin sodium and transfer the patient to another therapy.

Spinal/epidural anesthesia

Cases of neuraxial hematomas have been described when using enoxaparin sodium during simultaneous spinal/epidural anesthesia with the development of long-term or irreversible paralysis. The risk of these events is reduced when using the drug at a dose of 40 mg or lower. The risk increases with the use of higher doses of enoxaparin sodium, as well as with the use of indwelling catheters after surgery, or with the simultaneous use of additional drugs. affecting hemostasis, such as non-steroidal anti-inflammatory drugs. The risk also increases with traumatic or repeated spinal puncture or in patients with a history of spinal surgery or spinal deformity.

To reduce the possible risk of bleeding associated with the use of enoxaparin sodium and epidural or spinal anesthesia/analgesia, the pharmacokinetic profile of the drug must be taken into account.

Catheter insertion or removal is best done when the anticoagulant effect of enoxaparin sodium is low, but the exact time to achieve sufficient reduction in anticoagulant effect in different patients is unknown.

Catheter insertion or removal should occur at least 12 hours after administration of lower doses of enoxaparin sodium (20 mg once daily, 30 mg once or twice daily, 40 mg once daily) and at least after 24 hours after administration of higher doses of enoxaparin sodium (0.75 mg/kg body weight twice daily, 1 mg/kg body weight twice daily, 1.5 mg/kg body weight once daily).

At these time points, anti-Xa activity of the drug is still detectable, and time delays do not guarantee that the development of a neuraxial hematoma can be avoided. Patients receiving enoxaparin sodium at doses of 0.75 mg/kg body weight twice daily or 1 mg/kg body weight twice daily, with this (twice daily) dosing regimen, should not administer a second dose in order to to increase the interval before inserting or replacing a catheter.

Similarly, the possibility of delaying the next dose of the drug by at least 4 hours should be considered, based on an assessment of the benefit/risk ratio (risk of thrombosis and bleeding during the procedure, taking into account the presence of risk factors in patients). However, it is not possible to give clear recommendations on the timing of the next dose of enoxaparin sodium after catheter removal. It should be taken into account that in patients with creatinine clearance less than 30 ml/min, the elimination of enoxaparin sodium is slowed down. Therefore, in this category of patients, doubling the time from catheter removal should be considered: at least 24 hours for lower doses of enoxaparin sodium (30 mg once daily) and at least 48 hours for higher doses (1 mg/day). kg body weight per day).

If anticoagulant therapy is used as prescribed by a physician during epidural/spinal anesthesia or lumbar puncture, the patient should be closely monitored to detect any neurological symptoms such as back pain, sensory and motor impairment (numbness or weakness in the lower extremities), bowel and/or bladder functions. The patient should be instructed to immediately inform the doctor if the above symptoms occur. If symptoms consistent with a spinal cord hematoma are suspected, prompt diagnosis and treatment are necessary, including, if necessary, spinal cord decompression.

Heparin-induced thrombocytopenia

Enoxaparin sodium should be used with extreme caution in patients with a history of heparin-induced thrombocytopenia with or without thrombosis. The risk of heparin-induced thrombocytopenia may persist for several years. If the history suggests the presence of heparin-induced thrombocytopenia, then in vitro platelet aggregation tests are of limited value in predicting the risk of its development. The decision to use enoxaparin sodium in this case can only be made after consultation with an appropriate specialist.

Percutaneous coronary angioplasty

To minimize the risk of bleeding associated with invasive vascular instrumentation in the treatment of unstable angina and non-Q wave myocardial infarction and acute ST-segment elevation myocardial infarction, these procedures should be performed at intervals between the administration of enoxaparin sodium. This is necessary in order to achieve hemostasis after percutaneous coronary intervention.

If a closure device is used, the femoral artery sheath can be removed immediately. When using manual compression, the femoral artery sheath should be removed 6 hours after the last intravenous or subcutaneous injection of enoxaparin sodium. If treatment with enoxaparin sodium is continued, the next dose should be administered no earlier than 6-8 hours after removal of the femoral artery sheath. It is necessary to monitor the insertion site of the introducer to promptly detect signs of bleeding and hematoma formation.

Patients with mechanical artificial heart valves

The use of enoxaparin sodium for the prevention of thrombus formation in patients with mechanical artificial heart valves has not been sufficiently studied. There are isolated reports of the development of heart valve thrombosis in patients with mechanical artificial heart valves during therapy with enoxaparin sodium to prevent thrombosis. The evaluation of these reports is limited by the presence of competing factors that contribute to the development of thrombosis of prosthetic heart valves, including the underlying disease, and by the paucity of clinical data.

Pregnant women with mechanical artificial heart valves

The use of enoxaparin sodium for the prevention of thrombus formation in pregnant women with mechanical artificial heart valves has not been sufficiently studied. In a clinical study of pregnant women with mechanical artificial heart valves, when using enoxaparin sodium at a dose of 1 mg/kg body weight twice daily to reduce the risk of thrombosis and embolism, 2 out of 8 women developed blood clots that led to blocking of the heart valves and to the death of mother and fetus.

There have been isolated post-marketing reports of valvular thrombosis in pregnant women with mechanical prosthetic heart valves treated with enoxaparin sodium for thrombotic prophylaxis.

Pregnant women with mechanical artificial heart valves are at high risk of developing thrombosis and embolism.

Laboratory tests

At doses used for the prevention of thromboembolic complications, enoxaparin sodium does not significantly affect bleeding time and blood clotting parameters, as well as platelet aggregation or their binding to fibrinogen.

As the dose increases, the aPTT and activated clotting time may prolong. The increase in aPTT and activated clotting time are not in a direct linear relationship with the increase in the anticoagulant activity of the drug, so there is no need to monitor them.

Prevention of venous thrombosis and embolism in patients with acute therapeutic diseases who are on bed rest

In the event of the development of an acute infection or acute rheumatic conditions, the prophylactic use of enoxaparin sodium is justified if the above conditions are combined with one of the following risk factors for venous thrombus formation: • age over 75 years; • malignant neoplasms; • history of thrombosis and embolism; • obesity; • hormonal therapy; • heart failure; • chronic respiratory failure.

Use in pediatrics

The safety and effectiveness of enoxaparin sodium in children under 18 years of age have not been established.

Impact on the ability to drive vehicles and machinery

Enoxaparin sodium does not affect the ability to drive vehicles and machines.

Carrying out an azopyram test

Features of the event:

1. The instrument must be dry and at room temperature. If moisture particles remain on the surface, wipe the devices thoroughly with a dry cloth;
2. Place the tools in 1 layer on a clean napkin;
3. Pipette a drop of the prepared azopyram solution onto all cutting parts, as well as into the joints and handles;
4. Wait exactly 1 minute and evaluate the result.

How and with what to disinfect, sterilize and clean manicure instruments