Pentaglobin
Certain severe side effects may depend on the rate of administration, so the rate of administration recommended in the section "Dosage regimen, route of administration" must be strictly followed.
Certain side effects may occur most often:
- at a high rate of administration;
- in patients with hypogammaglobulinemia or agammaglobulinemia with or without IgA deficiency;
- in patients receiving human immunoglobulin for the first time, or in rare cases when switching to another immunoglobulin preparation, or if treatment with immunoglobulins has been carried out for a long time.
True hypersensitivity reactions occur in extremely rare cases in which there is no immunoglobulin A (IgA) in the blood and there are antibodies to IgA.
In rare cases, as a result of the administration of immunoglobulin, a decrease in blood pressure and, in isolated cases, anaphylactic shock are possible, even if the patient did not show hypersensitivity during the previous administration of the drug.
In most cases, possible complications can be avoided if:
- ensure that the patient does not exhibit allergic reactions to human immunoglobulins by first administering human immunoglobulin very slowly (0.4 ml/kg/hour);
- carefully monitor the patient during the entire administration of the drug and monitor for signs of undesirable effects. Patients who have never previously received human immunoglobulins, or who have previously received other immunoglobulins, or who have been administered immunoglobulins for a very long time should be especially closely monitored throughout the infusion and for at least 1 hour after its completion in order to monitor for the possible appearance of symptoms of side effects. . All other patients should be observed for at least 20 minutes after administration.
It should be taken into account for patients with known disorders of glucose metabolism that the drug contains glucose 27.5 mg/ml.
There is a suspected relationship between the administration of intravenous immunoglobulins and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis. It is assumed that in patients at risk, the administration of a high dose of immunoglobulin leads to a relative increase in blood viscosity.
Caution recommended
Prescribe and administer immunoglobulins to the following patients: the elderly, those with high blood pressure, diabetes mellitus, vascular disease or a history of thrombosis, hereditary or acquired thrombophilic disorders, patients who have been immobile for a long time, those with severe hypovolemia, and patients with medical conditions , increasing blood viscosity.
Cases of acute renal failure may very rarely occur in patients receiving immunoglobulins. In most cases, this side effect occurred in patients with additional risk factors: pre-existing renal dysfunction, diabetes mellitus, reduced circulating blood volume, excess body weight, taking medications that have a nephrotoxic effect, and age over 65 years.
When prescribing the drug and carrying out immunoglobulin treatment for all groups of patients, it is necessary:
- sufficient fluid intake before starting immunoglobulin infusion;
- monitoring the amount of urine;
- monitoring serum creatinine (an indicator of kidney function);
- refusal to take diuretics simultaneously.
In case of a negative effect on renal function, discontinuation of immunoglobulin administration should be considered.
Most often, impaired renal function and acute renal failure are associated with the use of drugs containing sucrose as a stabilizer. Therefore, patients with any risk factor are recommended to use immunoglobulins that do not contain sucrose, such as Pentaglobin. In addition, immunoglobulin preparations should be administered without exceeding the permissible rate (0.4 ml/kg/hour).
Additional data
For the production of Pentaglobin, only plasma from healthy donors is used, in which antibodies to HIV type 1 and 2, to the hepatitis C virus and the surface antigen of the hepatitis B virus were not detected, and the activity of liver enzymes (transaminase) does not exceed the normal limit value. In addition to testing the plasma of individual donors, first minipools are subject to control (PCR testing for HIV, hepatitis A, B and C viruses, parvovirus 19), and then the production pool of plasma, processed for Pentaglobin (repeated testing for antibodies to HIV-1/2, hepatitis B and C viruses, as well as PCR for HIV, hepatitis B and C viruses). A pool of plasma is used in production only if the test results are negative. Pentaglobin is produced by cold ethanol fractionation. In addition, virus removal and inactivation steps (octanoic acid precipitation, β-propiolactone treatment and filtration) are included in the production process.
Pentaglobin, 50 mg/ml, solution for infusion, 50 ml, 1 pc.
Certain severe side effects may be dependent on the rate of administration, so the rate of administration recommended in the Dosage and Administration section should be strictly followed.
Certain side effects may occur most often:
- at a high rate of administration,
- in patients with hypoagammaglobulinemia or agammaglobulinemia with or without IgA deficiency;
- in patients receiving human Ig for the first time or in rare cases when switching to another Ig drug, or if treatment with immunoglobulins was carried out for a very long time.
Hypersensitivity reactions in their true form occur in extremely rare cases in which there is no IgA in the blood and there are antibodies to IgA.
Sometimes, as a result of the administration of Ig, a decrease in blood pressure and, in isolated cases, anaphylactic shock (even if the patient did not show hypersensitivity during the previous administration of the drug) are possible.
In most cases, possible complications can be avoided if:
- make sure that the patient does not show allergic reactions to human Ig by first injecting human Ig very slowly (0.4 ml/kg/h);
- carefully monitor the patient during drug administration and monitor for signs of undesirable effects. Patients who have never previously received human Ig, or who have previously received other Ig, or if Ig have been administered for a very long time, should be observed especially closely to monitor for the possible appearance of symptoms of side effects throughout the infusion and for at least 1 hour after its completion. . All other patients should be observed for at least 20 minutes after administration.
Cases of acute renal failure may very rarely occur in patients receiving Ig. In most cases, this side effect occurred in patients with additional risk factors: impaired renal function, diabetes mellitus, low blood volume, excess body weight, taking medications that have a nephrotoxic effect, and age over 65 years.
When prescribing the drug and carrying out Ig treatment for all groups of patients, it is necessary:
- adequate fluid intake before starting Ig infusion;
- monitoring the amount of urine;
- monitoring serum creatinine (an indicator of kidney function);
- avoid simultaneous use of diuretics.
If there is a negative effect on renal function, discontinuation of Ig administration should be considered.
Most often, impaired renal function and acute renal failure are associated with the use of drugs containing sucrose as a stabilizer. Therefore, patients with any risk factor are recommended to use Igs that do not contain sucrose. In addition, Ig preparations should be administered without exceeding the permissible rate (0.4 ml/kg/h).
Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions.
There is no indication that immunoglobulins can affect the ability to drive a car or operate machinery.
Additional Information
For the production of Pentaglobin, only plasma from healthy donors is used, in which antibodies to HIV types 1 and 2, to the hepatitis C virus and the surface antigen of the hepatitis B virus were not detected, and the activity of liver enzymes (transaminases) does not exceed normal limits. In addition to testing the plasma of individual donors, first minipools are monitored (polymerase chain reaction (PCR) testing for HIV, hepatitis A, B and C viruses, parvovirus 19), and then the production pool of plasma, processed for Pentaglobin (repeated testing for antibodies to HIV types 1 and 2, hepatitis B and C, as well as by PCR for HIV, hepatitis B and C viruses). A pool of plasma is used in production only if the test results are negative.
Pentaglobin is produced by cold ethanol fractionation. In addition, virus removal and inactivation steps (octanoic acid precipitation, β-propiolactone treatment and filtration) are included in the production process.
Pentaglobin
Instructions for use:
Registration certificate:
П№011843/01-2000.
Human immunoglobulin for intravenous administration. Composition:
1 ml of solution contains: active components - human plasma proteins - 50 mg, of which immunoglobulin > 95% (immunoglobulin M (IgM) - 6 mg, immunoglobulin A (IgA) - 6 mg, immunoglobulin G (IGg) - 38 mg. other components - glucose monohydrate (27.5 mg), sodium ions (78 µmol), chloride ions (78 µmol), water for injection. Pentaglobin is a colorless or light yellow, transparent or slightly opalescent solution. Indications
:
Treatment of bacterial infections with concomitant use of antibiotics Replacement therapy in patients with immunodeficiency or severe secondary antibody deficiency syndrome (patients with immune deficiency or suppressed immune defenses) Contraindications
:
Hypersensitivity to human immunoglobulin, especially in rare cases of deficiency of immunoglobulin class A in the blood (IgA) and the presence of antibodies against IgA.
Pregnancy and lactation
... The lack of risk of using this drug during pregnancy has not been studied in controlled clinical studies, therefore it should be used with caution during pregnancy and lactation, although long-term experience with the medical use of immunoglobulins does not allow us to expect any harmful effects on the course of pregnancy, as well as on the fetus and newborn.
Injected immunoglobulins are excreted in mother's milk and may contribute to the transfer of protective antibodies to newborns. Precautions for use:
Certain severe side effects may depend on the rate of administration, so the rate of administration recommended in the section "Dosage and Administration" must be strictly followed.
The patient should be under medical supervision throughout the entire infusion and for at least 20 minutes after its completion in order to monitor for possible symptoms of side effects. Driving a car and machinery.
There is no indication that immunoglobulins can affect the ability to drive a car or operate machinery.
Drug interactions:
Pentaglobin should not be used simultaneously with calcium gluconate, as there are suspicions that simultaneous use may cause adverse effects in infants.
Live virus vaccines and the administration of immunoglobulins may adversely affect the effect of live vaccines against viral diseases such as measles, rubella, mumps and chickenpox for at least 6 weeks and up to 3 months. Laboratory tests:
after the administration of immunoglobulin, a temporary increase in the titer of various passively administered antibodies is possible, which can lead to false positive analysis data in a serological study.
Method of administration and dosage:
The dosage depends on the immune status of the patient and the severity of the disease.
The following dosage recommendations can serve as a guide: 1. For newborns and infants: daily 5 ml/kg body weight for 3 consecutive days. The need for a repeat course depends on the clinical course of the disease. 2. For children and adults; a) therapy of severe bacterial infections; daily 5 ml/kg body weight for 3 consecutive days. The need for a repeat course depends on the clinical course of the disease. b) Replacement therapy in patients with immunodeficiency and secondary antibody deficiency syndrome: 3-5 ml/kg body weight. If necessary, repeat the course after a week's break. Method of administration:
Before administration, Pentaglobin must be visually checked to see if the solution contains suspended particles and whether it is colored.
A solution that is opaque or contains sediment should not be used. Light opalescence is a property of Pentaglobin. The contents of opened ampoules or vials should be used immediately. Due to the risk of bacterial contamination, unused solution should be discarded. Before administration, the drug must be warmed to room temperature or body temperature. Pentaglobin should be administered intravenously at the following rates: newborns and infants
- 1.7 ml/kg body weight/hour using a perfuser;
children and adults
- 0.4 ml/kg body weight/hour, alternatively: the first 100 ml 0.4 ml/kg body weight/hour, then continuously 0.2 ml/kg body weight/hour until reaching 15.0 ml /kg body weight for 72 hours.
Examples
:
Body mass Total dose 1st day Injection rate Duration of administration Newborn 3 kg 15 ml 5 ml/hour 3 hours Child 20 kg 100ml 8 ml/hour 12.5 hours Adult 70 kg 350ml 28 ml/hour 12.5 hours
Alternatively: first 28 ml/hour -3.5 hours, then 14 ml/hour - 68 hours
The above rate of administration must be especially strictly observed in patients with hypoagammaglobulinemia or agammaglobulinemia (complete or partial deficiency of immunoglobulins) receiving immunoglobulins for the first time. Patients should be observed for a minimum of 20 minutes after completion of the infusion. Pentaglobin can only be mixed with 0.9% sodium chloride solution. Other drugs cannot be added to the Pentaglobin solution, since changes in the electrolyte concentration or pH value can cause denaturation or precipitation of the protein. Side effect
Possible side effects include chills, headache, fever, nausea, vomiting, allergic reactions, joint pain and mild back pain.
In isolated cases, primarily with high dosages of intravenous immunoglobulins, cases of signs of aseptic meningitis, such as severe headache, nausea, vomiting, fever, neck stiffness, photosensitivity and impaired consciousness, have been described. These symptoms can appear within a few hours and up to several days after the infusion and disappear without a trace after the end of therapy. Particular caution should be exercised in patients with a known migraine tendency. In isolated cases, primarily in patients with existing renal impairment, further worsening of renal failure may occur with an increase in serum creatinine, up to anuria. The appearance of these symptoms is sometimes observed with the administration of large volumes of immunoglobulins; they disappear without a trace after cessation of therapy. In rare cases, as a result of the administration of immunoglobulin, a decrease in blood pressure and, in isolated cases, anaphylactic shock are possible, even if the patient did not show excessive sensitivity during the previous administration of the drug. The patient should inform the doctor about all manifestations of side effects. When using drugs from human blood or plasma due to the transmission of infectious disease agents, infection by the latter cannot be completely excluded. This also applies to pathogens of a still unknown nature. To reduce the risk of pathogen transmission, donors are screened using strict criteria, donated plasma is tested and selected, and the plasma pool is monitored. The manufacturing process includes steps to remove and/or inactivate pathogens. If intolerance reactions to the drug occur, it is necessary to either reduce the rate of administration or interrupt it until the symptoms disappear. If severe side effects are observed after stopping the infusion, appropriate treatment should be initiated. In case of anaphylactic reactions or shock, treatment should be carried out in accordance with the rules for shock therapy. Release form:
Solution for intravenous administration Ampoule containing 10 ml or 20 ml. Bottle for infusion 50 ml or 100 ml.
Storage:
Pentaglobin should be stored at a temperature of + 2 to + 8 ° C, protected from light.
The drug must not be frozen! Shelf life:
2 years.
After the expiration date indicated on the packaging box and on the label, the medicinal product cannot be used. General instructions:
For the production of Pentaglobin, only plasma from healthy donors is used, in which antibodies to HIV type 1 and 2 (HIV), to the hepatitis C virus (HCV) were not detected. , hepatitis B virus surface antigen (HbsAg), as well as the level of liver enzyme (transamyase) do not exceed the normal limit value. In addition to individual testing of plasma from individual donors for the above-mentioned infectious markers, a pool of plasma processed into Pentaglobin is subject to control. At the same time, testing for HIV and HCV antibodies is carried out again, as well as for HbsAg, and the plasma pool goes into production only if the results are negative. Pentaglobin is prepared by cold fractionation with a standard. To inactivate and remove possible contaminating viruses, b-plropiolactone treatment and filtration are carried out.
Manufacturing company:
Biotest Pharma GmbH, Germany. Website of the manufacturer: https://www.biotestpharma.ru
