Immune-cedrion pore liof solution vnutremyshechno 300 mcg 1500m N1
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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 antihoresus Rho (D)
Release form
Lyophilisate
Composition
Proteins of human plasma (containing at least 90% of immunoglobulins), including human immunoglobulin antirhesus Rh0 (D), glycine, sodium chloride
Pharmacological effect
Immunoglobulin. The active component of the drug is specific antibodies against Rh0 (D) -antigen of human erythrocytes. The drug prevents isoimmunization in the Rh-negative woman’s body as a result of fetal blood entering the mother’s bloodstream at the birth of a Rh-positive baby, in spontaneous and induced abortions, in the case of amniocentesis or in the case of abdominal injury during pregnancy. Anti-D immunoglobulins are polyclonal immunoglobulins, the mechanism of action of which is to neutralize the Rh0 (D) -antigens present in the Rh-positive blood of the embryo. The period of effective action of the drug is on average from 48 to 144 hours, while the highest concentration of human immunoglobulin Rh0 (D) antirhesus is reached on average 56 hours after drug administration. The drug is an immunologically active protein fraction isolated from human viral-inactivated plasma tested for lack of antibodies to human immunodeficiency viruses (HIV-1, HIV-2), hepatitis C virus and hepatitis B surface antigen
Pharmacokinetics
The determined value of the concentration of antibodies is reached in the blood approximately 20 minutes after the intramuscular injection of the drug. The plasma Cmax of antibodies is usually achieved 2-3 days after injection. T1 / 2 of a human immunoglobulin Rh0 (D) antiresis is individual, equal to that of a normal human immunoglobulin and is 3-4 weeks. Immunoglobulin and its complexes are destroyed in the cells of the reticuloendothelial system.
Indications
- Prevention of anti-D (Rh0) immunization in Rh-negative women (Rh0 (D)), not sensitized to the Rh0 (D) -antigen, and in women with mild-positive Rh blood (Du), during pregnancy and birth Rh -positive child. The drug is used in artificial and spontaneous abortion in Rh-negative women who are not sensitized to the Rh0 (D) antigen, in the case of Rh-positive blood of the father, as well as in amniocentesis, external rotation on the head, injury to the abdominal cavity, prenatal bleeding , ectopic pregnancy and villous chorion test; - Prevention of anti-D (Rh0) immunization in Rh-negative patients after incompatible transfusion of Rh-positive blood or erythrocyte concentrates.
Contraindications
- Hypersensitivity to the components of the drug; - Sensitized to Rh0 (D) -entigen anti-Rh-positive and Rh-negative women, in the serum of which rh-antibodies are detected; - Newborns.
Precautionary measures
Keep out of the reach of children.
Use during pregnancy and lactation
This drug is used during pregnancy and for 72 hours after delivery. No adverse effects on the course of pregnancy, the fetus or the newborn were noted.
Dosage and administration
The solution of the drug is administered in / m. Post-natal prophylaxis. 1000–1500 IU (200–300 mcg) is recommended as the optimal standard dose without prior testing for infiltration into the mother’s bloodstream of fetal hemoglobin (HbF) according to the Kleijauer-Bettke method. The drug is administered to the mother as soon as possible after childbirth, but not later than 72 hours. Prenatal and postpartum prophylaxis. The first dose of 1000-1500 IU (200-300 mcg) at the 28th week of pregnancy. The next dose of 1000-1500 IU (200-300 mcg) is administered within 72 hours after birth, if the baby is born Rh-positive. After an abortion, an ectopic pregnancy, or a vestibule. During the first 72 hours after the intervention, the drug is administered at a dose of 600-750 IU (120-150 μg) before the 12th week of pregnancy; 1250-1500 IU (250-300 mcg) after 12 weeks of pregnancy; 1250-1500 IU (250-300 mcg) after amniocentesis or chorionic biopsy. After an incompatible transfusion of Rh-positive blood. 500 IU-1250 IU (100-250 mcg) for every 10 ml of transfused blood for several days. In case of coagulation system pathology, when intramuscular administration of drugs is contraindicated, human immunoglobulin Rh0 (D) can be administered sc.After the injection, a compress is carefully applied to the injection site. If a large total dose is required (more than 5 ml), it is recommended to divide it into smaller doses and make injections in different places. Preparation and administration of the preparation solution. Warm the vial with the lyophilized preparation and the vial with the solvent to room temperature. or body temperature. Take the contents of the ampoule with the solvent into the injection syringe, remove the protective cap from the rubber stopper of the vial with lyophilisate and slowly introduce the solvent into the vial; shake the vial with the solution gently or stand until the lyophilisate is completely dissolved; type solution in a syringe; change the needle and make an injection. Incomplete dissolution of the lyophilisate leads to loss of drug activity. Do not use if the solution is cloudy or contains a precipitate. The lyophilisate from the opened bottle should be restored and used immediately. The remnants of the drug must be destroyed.
Side effects
Local reactions: pain at the injection site. This can be avoided if a large volume solution is administered in several doses of less than 5 ml in several different places. Systemic reactions: infrequently - fever, skin reactions, chills; rarely - dyspeptic symptoms (nausea and vomiting), lowering blood pressure, tachycardia, allergic or anaphylactic reactions.
Overdose
No cases of overdose have been reported.
Interaction with other drugs
Human immunoglobulin Rh0 (D) cannot be mixed with other drugs. Reduces the activity of attenuated live vaccines against measles, rubella, mumps, chicken pox for a period of up to 3 months.
special instructions
You can not enter the drug in / in connection with the possibility of the development of shock. The introduction should be in / m. In order to prevent the drug from getting into the blood vessels, it is necessary to pull the syringe plunger towards yourself and check if there is no blood in the syringe before starting the drug. True allergic reactions to the i / m injected human immunoglobulin anti-Rh0 (D) are rare. When the first symptoms of anaphylactoid reactions develop, anti-shock therapy is performed using antihistamines, alpha adrenomimetics and GCS. Immunoglobulin intolerance develops in very rare cases of immunoglobulin A deficiency (IgA), when the patient has antibodies against IgA. Observation of the patient continues for 30 - 60 minutes after injection. The drug is immediately discontinued if an allergic or anaphylactic reaction is suspected.If shock develops, anti-shock therapy is used. After the introduction of immunoglobulin, a passive increase in the antibody content in the patient's blood can be observed, which can lead to an erroneous false-positive interpretation of the results of serological testing. The introduction of human immunoglobulin Rh0 (D) antiresurus greatly affects the results of studies such as the determination of antibodies and blood groups, including the Coombs test and the antiglobulin test. Viral safety. In the manufacture of drugs from human blood or plasma, a set of measures is used to prevent possible transmission of infection to patients. These measures include the careful selection of healthy donors, guaranteeing the elimination of the risk of infection of donors, as well as monitoring the blood of each donor and the total plasma pool for the absence of viruses and infections. Each plasma unit used to manufacture the drug is tested for the absence of the surface antigen of the hepatitis B virus and antibodies to human immunodeficiency viruses (HIV-1, 2), to the hepatitis C virus. Each plasma pool is also monitored for the absence of HCV RNA chain reaction. For the manufacture of the drug using only the plasma, which gives negative results for all the above tests. The production of human blood preparations also includes the stages of the production processing of human blood or plasma, which allow inactivating or removing viruses. Despite this, when using drugs made from human blood or plasma, it is impossible to completely exclude the possibility of transmission of infection, including unknown or new viruses and other infectious agents.