Pentaglobin solution for intravenous administration of 50 ml vials
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Description
The release of the immunobiological medicinal product is carried out according to the doctor's prescription and if the thermocontainer from the customer buys in which the medicinal product is placed, the delivery of this medicinal product to the medical organization under the condition of storage in a special thermal container shall not exceed 48 hours after its purchase.
Active ingredients
Human immunoglobulin normal [IgG + IgA + IgM]
Release form
Solution
Composition
1 ml contains: Active substance: plasma protein 50 mg, incl. Immunoglobulin IgM 6 mg, Immunoglobulin IgA 6 mg, Immunoglobulin IgG 38 mg.
Pharmacological effect
Human Ig, reducing the lack of antibodies, reduces the risk of developing infections in patients with primary and secondary immunodeficiency.
Indications
Congenital immunodeficiency states (congenital full or partial immunodeficiency, variational immunodeficiency, severe combined immunodeficiency, Wiskott-Aldrich syndrome); idiopathic thrombocytopenic purpura (especially acute forms in children). Acquired immunodeficiency (chronic lymphocytic leukemia, AIDS in children, bone marrow transplantation and other types of transplants); Kawasaki syndrome (as an adjunct to acetylsalicylic acid therapy); prevention and treatment of infectious diseases.
Contraindications
Hypersensitivity, IgA deficiency in the presence of the patient's antibodies against IgA. With caution: pregnancy, lactation.
Precautionary measures
Certain severe side effects may depend on the speed of administration, therefore it is necessary to strictly observe the rate of administration recommended in the section "
Dosage and administration
". Certain side effects can occur most often: - at high speed of administration, - in patients with hypoagammaglobulinemia or agammaglobulinemia in the presence of or in the absence of IgA-deficiency; - in patients receiving human Ig for the first time or in rare cases when switching to another Ig drug, or if immunoglobulins were treated for a very long time. Reak and hypersensitivity in its true form are found in extremely rare cases in which there is no IgA in the blood and antibodies to IgA. Sometimes, as a result of the introduction of Ig, a decrease in blood pressure is possible and in rare cases anaphylactic shock (even if the patient did not show hypersensitivity in the previous administration of the drug) . In most cases, possible complications can be avoided if: - to make sure that the patient does not exhibit allergic reactions to human Ig,Introducing first the human Ig very slowly (0.4 ml / kg / h) - carefully observe the patient during the administration of the drug and monitor the appearance of signs of undesirable effects. Particularly carefully in order to control the possible occurrence of symptoms of side effects should be monitored throughout the infusion and at least 1 h after its termination for patients who have never received human Ig, or have received other Ig to date, or if Ig was administered very long . All other patients should be monitored for at least 20 minutes after administration. Patients with Ig administration can rarely have cases of acute renal failure. In most cases, this side effect occurred in patients with additional risk factors: impaired renal function, diabetes, lowered BCC, overweight, taking medications that have a nephrotoxic effect, as well as age over 65 years. for all groups of patients it is necessary: - sufficient fluid intake before the start of the infusion of Ig; - observation of the amount of urine; - monitoring of the serum creatinine content (indicator of kidney function); diuretikov.V case of receiving a negative impact on renal function should consider discontinuing administration Ig.Naibolee often renal dysfunction and acute renal failure associated with the use of preparations containing sucrose as a stabilizer. Therefore, it is recommended that patients with any risk factor use Ig, which do not contain sucrose. In addition, Ig drugs should be administered without exceeding the permissible speed (0.4 ml / kg / h). Impact on the ability to drive a car or perform work that requires an increased rate of physical and mental reactions. There is no indication that immunoglobulins can affect the ability to drive a car or maintain machinery.Use during pregnancy and lactation
With care: pregnancy, lactation.
Dosage and administration
In / in the drip. Before the introduction of the drug should be heated to room temperature or body temperature.Only a clear solution can be injected. The initial infusion rate is 30 drops / min (1.65 ml / min), after 10 minutes the rate is increased to 40 drops / min (2.2 ml / min). Substitution therapy for primary and secondary immunodeficiencies (including children with AIDS ): 0.1-0.4 g / kg with an interval of 1 month to increase the level of IgG. In the absence of a sufficient increase in the IgG level or an excessively rapid decrease in the rate, the dose is increased to 0.8 g / kg or the time interval between injections is reduced. Idiopathic thrombocytopenic purpura — 0.8–1 g / kg (if necessary, repeat administration for 2 or 3 days) or 0.4 g each. / kg for 2-5 days. If necessary, repeat the course. Allogenic bone marrow transplantation - 0.5 g / kg for 7 days. Kawasaki syndrome - 1.6-2 g / kg in several doses (within 2-5 days) or 2 g / kg in a single dose. For severe bacterial infections (including sepsis) and viral infections — 0.4–1 g / kg daily for 1–4 days. To prevent infections in premature infants with low birth weight, 0.5–1 g / kg with an interval of 1–2 weeks. In Guillain-Barre syndrome, chronic inflammatory demyelinating neuropathy - 0.4 g / kg for 5 days. If necessary, repeat the treatment at intervals of 4 weeks. 0.4 g / kg daily is administered to patients with coronary artery disease and cerebral ischemia.
Side effects
Headache, chills, fever, nausea, vomiting, aching joints, back pain, allergic reactions. Rarely - decreased blood pressure, in rare cases - anaphylactic shock, symptoms of aseptic meningitis (severe headache, nausea, vomiting, fever body, stiff neck, photosensitivity, impaired consciousness), exacerbation of renal failure in patients with impaired renal function.
Overdose
Overdose of the drug in patients belonging to the risk group, especially the elderly, as well as in patients with impaired renal function can lead to hypervolemia (increased BCC) and increased blood viscosity.
Interaction with other drugs
Reduces the activity of attenuated live vaccines against measles, rubella, mumps, chicken pox (with the introduction in the first 2 weeks after vaccination against measles, mumps and rubella, vaccinations with these vaccines should be repeated no earlier than 3 months). You can mix only with a 0.9% solution sodium chloride.Other drugs can not be added to the solution, because a change in electrolyte concentration or pH value may cause denaturation or precipitation of the protein.
special instructions
A temporary increase in the content of the administered antibodies in the patient's blood after the introduction of Ig may cause false positive results of serological tests. The recommended rate of administration of the drug should not be exceeded (severe side effects are likely). During the entire infusion period and 20 minutes after it, the patient must be under medical supervision.