Pentaglobin
Pentaglobin: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Drug interactions
- 11. Analogs
- 12. Terms and conditions of storage
- 13. Terms of dispensing from pharmacies
- 14. Reviews
- 15. Price in pharmacies
Latin name: Pentaglobin
ATX code: J06BA02
Active ingredient: Human immunoglobulin normal [IgG + IgA + IgM] (Immunoglobulin human normal [IgG + IgA + IgM])
Manufacturer: Biotest Pharma GmbH (Germany)
Description and photo update: 03.11.2017
Pentaglobin is a preparation containing normal human immunoglobulin [IgG + IgA + IgM], including a wide range of antibodies that are active against pathogens of various infections and their toxins.
Release form and composition
Dosage form of Pentaglobin - solution for infusion: light yellow or colorless liquid, slightly opalescent or transparent (10 ml in ampoules, 1 ampoule in a cardboard box; 10, 20, 50 or 100 ml each in colorless glass vials with a rubber stopper under aluminum cap, in a cardboard box 1 bottle).
1 ml of solution for infusion contains:
- Active substance: human plasma proteins - 50 mg (more than 95% is immunoglobulin (Ig), including IgA - 6 mg, IgM - 6 mg, IgG - 38 mg);
- Auxiliary components: chlorine ions, sodium ions, dextrose monohydrate, water for injection.
Pharmacological properties
Pharmacodynamics
Pentaglobin contains immunoglobulin G (IgG), immunoglobulin A (IgA) and immunoglobulin M (IgM) in high concentrations, containing a wide range of antibodies against pathogens of various infectious diseases and their toxins. Pentaglobin is produced from a pool of blood plasma obtained from over 1000 donors. Due to the high level of IgA and especially IgM, the drug has an increased titer of agglutinating antibodies against bacterial antigens than is released from other standard immunoglobulins for infusion.
Therapeutic doses of Pentaglobin allow to normalize the pathologically low concentration of immunoglobulins. For other indications (except for substitution therapy in patients with immunodeficiency), the mechanism of action of the drug consists of an immunomodulatory effect, although it remains poorly understood.
Pharmacokinetics
When administered intravenously, the bioavailability of the immunoglobulin is 100%. It is distributed between blood plasma and extravascular fluid rather quickly, and after 3-5 days, equilibrium is established between the extravascular and intravascular space. The half-life of immunoglobulins contained in the preparation is identical to that of immunoglobulins synthesized in the body. The half-life varies significantly from patient to patient, especially when diagnosed with primary immunodeficiency. Utilization of immunoglobulins and immunoglobulin complexes is carried out by the cells of the reticuloendothelial system.
Indications for use
- Bacterial infections - for concomitant therapy in combination with antibiotics;
- Immunodeficiency states or severe secondary antibody deficiency syndrome (immune deficiency or suppressed immune defense) - as replacement therapy.
Contraindications
- Hypersensitivity to human immunoglobulin, especially in patients with immunoglobulin A deficiency and the presence of antibodies against it in the blood;
- Individual intolerance to the components of the drug.
Immunoglobulins should be used with caution during pregnancy and breastfeeding.
Instructions for the use of Pentaglobin: method and dosage
Pentaglobin is intended for intravenous (IV) drip.
When preparing for the infusion, it is necessary to visually verify that there are no suspended particles in the solution and that it corresponds to its physical properties. Do not use the drug if there is a sediment in it.
You can mix the solution only with 0.9% sodium chloride solution for injection.
Before opening the ampoule, its contents should be heated to body temperature or room temperature.
Ampoules and vials should be opened immediately before the infusion.
The infusion rate has age restrictions:
- Newborns and infants: using a perfuser at the rate of 1.7 ml per 1 kg of body weight per hour;
- Children: 0.4 ml per 1 kg of body weight per hour;
- Adults: the first 100 ml of 0.4 ml of 1 kg of body weight per hour, then continuously of 0.2 ml per 1 kg of body weight per hour until a rate of 15 ml per 1 kg of body weight is reached within three days.
The dose of the drug is prescribed by the doctor, taking into account the severity of the disease and the patient's immune status.
Recommended dosage regimen:
- Severe bacterial infections, replacement therapy in children with immunodeficiency and secondary antibody deficiency syndrome: 5 ml per 1 kg of the child's weight daily, the course of treatment is 3 days;
- Severe bacterial infections in adults and children: daily - at the rate of 5 ml per 1 kg of patient weight, the course of treatment is 3 days;
- Substitution therapy in adults and children with secondary antibody deficiency syndrome and immunodeficiency: 3-5 ml per 1 kg of body weight, if it is necessary to repeat the course, take a break for 7 days.
A repeated course is prescribed depending on the clinical course of the disease.
The rest of the solution in the ampoule or vial must be disposed of.
Side effects
- Possible: nausea, chills, vomiting, fever, headache, allergic reactions, mild back pain, arthralgia;
- Rarely: a sudden drop in blood pressure, the appearance of signs of aseptic meningitis, hemolytic anemia (hemolysis), transient transient skin reaction (hyperemia, rash), acute renal failure, increased serum creatinine concentration;
- In isolated cases: anaphylactic shock (including in the absence of hypersensitivity in the patient during the previous administration); signs of thrombosis in overweight patients, severe hypovolemia, impaired blood supply to the heart or brain (cardiological or cerebral ischemia), in old age.
Overdose
An overdose of Pentaglobin in patients at risk, especially in patients with renal dysfunction and in the elderly, can provoke an increase in blood viscosity and hypervolemia (an increase in the volume of blood circulating in the circulatory system).
special instructions
The risk of certain severe side effects can be directly related to the rate of infusion, therefore, the recommended rate of administration of Pentaglobin should be strictly observed.
The development of undesirable phenomena are more often susceptible to: patients with agammaglobulinemia or hypoagammaglobulinemia with or without a deficiency of immunoglobulin A, if the use of human immunoglobulin has been carried out for a long time or is being made for the first time, and in rare cases - when switching to other immunoglobulin preparations.
Extremely rare hypersensitivity reactions appear in patients with no immunoglobulin A in the blood and in the presence of antibodies to it.
With the development of shock against the background of intolerance reactions, it is necessary to carry out emergency measures of anti-shock therapy.
To avoid possible complications, the drug should be administered at a rate of 0.4 ml per 1 kg of body weight per hour, making sure that there are no symptoms of allergic reactions, switch to the recommended rate of administration, under close supervision of the patient's condition. After the administration of the drug, the patient's condition must be monitored within 20 minutes. Patients receiving Pentaglobin for the first time or after a long break require special monitoring during the infusion and within one hour after its end.
Cases of acute renal failure with the introduction of immunoglobulin may occur more often in patients with diabetes mellitus, impaired renal function, overweight, low circulating blood volume, taking medications with nephrotoxic effects, over the age of 65 years. With the introduction of the drug, it is necessary to ensure sufficient fluid intake before the start of the infusion, control the amount of urine, serum creatinine content, exclude concomitant diuretic therapy. If a negative effect of immunoglobulin on renal function is diagnosed, the solution should be discontinued.
For the treatment of patients with additional risk factors for the development of renal dysfunction and acute renal failure, it is recommended to use immunoglobulin preparations without sucrose and to observe an injection rate of no more than 0.4 ml per 1 kg of body weight per hour.
The effect of Pentaglobin on the patient's ability to drive vehicles and mechanisms has not been established.
Application during pregnancy and lactation
Controlled clinical studies of the safety of Pentaglobin use during pregnancy have practically not been conducted. However, the long-term experience of medical therapy with immunoglobulins suggests that there is no negative effect of immunoglobulins on the woman's body during pregnancy and breastfeeding, and there are no serious risks to the fetus and child, so the drug can be used with caution. The injected immunoglobulins pass into breast milk and can cause the transmission of protective antibodies to newborns.
Drug interactions
According to the instructions, Pentaglobin can adversely affect live viral vaccines against measles, rubella, chickenpox, mumps, so vaccination should be started no earlier than 3 months after the administration of immunoglobulin. Vaccination against measles can only be done after a blood test to determine if the patient has the appropriate antibodies.
When conducting laboratory serological studies after the introduction of immunoglobulin, it is possible to obtain false positive test data. Passive administration of antibodies against erythrocyte antigens can affect the following serological parameters: alloantibodies to erythrocytes, haptoglobin, reticulocyte count.
The risk of developing undesirable effects increases when Pentaglobin is administered to infants in combination with calcium gluconate.
Analogs
The analogs of Pentaglobin are: Immunoglobulin complex preparation, Immunoglobulin complex preparation for enteral administration.
Terms and conditions of storage
Store in a dark place at temperatures up to 2-8 ° C, do not freeze. Keep out of the reach of children.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Pentaglobin
The few reviews of Pentaglobin are almost all positive. There are frequent references to the high efficiency of the drug in the treatment of sepsis (blood poisoning), in which it turned out to be a real "panacea" for many patients. The drug has also shown good results in the treatment of bacterial infections in both children and adults.
There are very few reviews of the use of Pentaglobin in the treatment of immunodeficiency, but the overall beneficial effect of the drug on the body suggests that it is well tolerated and effective in this case. The disadvantages of the drug include the high cost.
Price for Pentaglobin in pharmacies
The approximate price for Pentaglobin, supplied in 10 ml vials, is 2,800-2,900 rubles. You can buy the drug in 50 ml bottles for 12,960-13,600 rubles, and one 100 ml bottle will cost 22,400-26,000 rubles.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
