Immunoro Kedrion
Immunoro Kedrion: 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: Immunoro kedrion
ATX code: J06BB01
Active ingredient: Human anti-d immunoglobulin (Human anti-d immunoglobulin)
Manufacturer: KEDRION SpA (Italy)
Description and photo update: 18.10.2018
Immunoro Kedrion is a drug used to prevent Rh-conflict; specific immunoglobulin.
Release form and composition
The dosage form is a lyophilisate for preparing a solution for intramuscular (intramuscular) administration: light yellow or white; solvent - transparent, colorless; prepared solution - light yellow or opalescent colorless (in glass vials of 0.3 mg, in a cardboard box 1 bottle complete with a solvent in ampoules of 2 ml).
Composition of 1 ml of ready-made solution:
- active substance: human plasma proteins containing at least 90% of immunoglobulins - 25-180 mg [including human immunoglobulin anti-rhesus Rh0 (D) - 0.15 mg];
- auxiliary components: glycine - 22.5 mg; sodium chloride - 9 mg;
- solvent: water for injection - up to 1 ml.
Pharmacological properties
Pharmacodynamics
Immunoro Kedrion is an immunologically active protein fraction isolated from virus-inactivated human plasma, which has been tested for the absence of hepatitis B virus surface antigen and antibodies to hepatitis C virus, human immunodeficiency viruses (HIV-1 and HIV-2).
The active substance of Immunoro Kedrion is specific antibodies against the Rh0 (D) antigen of human erythrocytes. The drug helps to prevent isoimmunization in a woman's Rh-negative body as a result of the flow of fetal blood into the mother's bloodstream at the birth of a Rh-positive child, during artificial and spontaneous abortions, in cases of amniocentesis or when trauma to the abdominal organs during pregnancy.
Anti-D immunoglobulins are polyclonal immunoglobulins, the mechanism of their action is to neutralize Rh0 (D) antigens, which are present in the Rh-positive blood of the embryo. The average time of the effective action of Immunoro Kedrion is 48-144 hours, while after the administration of the drug, the highest concentration of human immunoglobulin anti-rhesus Rh0 (D) is achieved usually after 56 hours.
Pharmacokinetics
After i / m injection of the drug, the determined value of the concentration of antibodies is usually reached in the blood after 20 minutes, the maximum plasma concentration of the active substance of antibodies in the blood - after 2–3 days.
The half-life of human immunoglobulin anti-rhesus Rh0 (D) is individual, usually it is 3-4 weeks and is equal to that of human immunoglobulin. The destruction of immunoglobulin and its complexes occurs in the cells of the reticuloendothelial system.
Indications for use
- prevention of anti-D (Rh0) immunization in Rh-negative women [Rh0 (D)], who are not sensitized to the Rh0 (D) antigen, and in women with slightly Rh-positive blood (Du) during pregnancy and at birth, Rh-positive child. Immunoro Kedrion can be used for spontaneous / artificial termination of pregnancy in Rh-negative women who are not sensitized to the Rh0 (D) antigen, in cases of Rh-positive blood belonging to the father, as well as in diseases / conditions such as amniocentesis, external turn to head, trauma to the abdominal organs, ectopic pregnancy, prenatal bleeding and chorionic villus sampling;
- prevention of anti-D (Rh0) immunization in Rh-negative patients after incompatible transfusion of Rh-positive erythrocyte concentrates or blood.
Contraindications
- Rh0 (D) -antigen sensitized Rh-negative and Rh-positive women, whose serum contains Rh antibodies;
- neonatal period;
- individual intolerance to the components of the drug.
Instructions for use Immunoro Kedrion: method and dosage
The solution should be injected intramuscularly.
Recommended dosage regimen:
- postpartum prophylaxis: the optimal standard dose without preliminary testing for infiltration is 0.2–0.3 mg into the mother's bloodstream of fetal hemoglobin (HbF) according to the Kleihauer-Betke method. The solution should be administered as early as possible after delivery, but no later than 72 hours;
- pre- and postnatal prophylaxis: the first dose at the 28th week of pregnancy - 0.2–0.3 mg; if the baby is born Rh-positive, the same dose is given within 72 hours of delivery;
- states after termination of pregnancy, cystic drift or ectopic pregnancy: the dose during the first 72 hours after the intervention is 0.12–0.15 / 0.25–0.3 mg (before / after the 12th week of pregnancy); after amniocentesis or chorionic biopsy - 0.25–0.3 mg;
- conditions after incompatible transfusion of Rh-positive blood: within several days 0.01-0.025 mg for each 1 ml of transfused blood.
In cases of the presence of pathologies of the coagulation system, intramuscular administration of Immunoro Kedrion is contraindicated, therefore the drug can be administered subcutaneously. After the injection, a compress is gently applied to the injection site.
If large total doses (more than 5 ml) are required, it is recommended to separate them and inject the solution into different places.
Before preparing the drug, the vial with the lyophilisate and the ampoule with the solvent must be warmed to body temperature or room temperature. Incomplete dissolution of the lyophilisate can lead to a loss of solution activity. From the opened vial, the lyophilisate must be reconstituted and used immediately.
Side effects
- systemic reactions: infrequently - skin reactions, fever, chills; rarely - dyspeptic symptoms (in the form of nausea and vomiting), lowering blood pressure, anaphylactic / allergic reactions, tachycardia;
- local reactions: pain at the injection site (the likelihood of this disorder can be reduced by injecting doses of less than 5 ml in several different places).
Overdose
To date, no cases of overdose have been reported.
special instructions
Intravenous Immunoro Kedrion is not administered, which is associated with the likelihood of shock. To avoid getting the drug into the blood vessels, before starting the injection, you need to pull the syringe plunger towards you and check for the absence of blood in the syringe. The development of true allergic reactions to i / m injected human immunoglobulin anti-rhesus Rh0 (D) is rare. When the first symptoms of anaphylactoid reactions occur, anti-shock therapy should be carried out using alpha-adrenergic agonists, antihistamines and glucocorticosteroids.
Intolerance to immunoglobulins occurs in very rare cases of immunoglobulin A (IgA) deficiency, when the patient has antibodies against IgA.
After the injection, the observation of the patient's condition should continue for 30-60 minutes. If allergic / anaphylactic reactions are suspected, the administration of Immunoro Kedrione should be stopped immediately. In cases of shock, anti-shock therapy is prescribed.
After administration of the drug, a passive increase in the content of antibodies in the patient's blood can be observed, which can lead to an erroneous false-positive interpretation of the results of serological testing. Immunoro Kedrion can have a significant impact on the determination of antibodies and blood type, including antiglobulin test and Coombs' test.
Despite the safety measures taken during the manufacture of the drug, when using drugs made from human plasma / blood, it is impossible to completely exclude the possibility of transmission of infection, including unknown / new types of viruses and other infectious agents.
Application during pregnancy and lactation
According to the instructions, Immunoro Kedrion is used during pregnancy and for 72 hours after childbirth. No harmful effect on the course of pregnancy, as well as on the fetus or newborn was noted.
Drug interactions
Immunoro Kedrion cannot be mixed with other drugs / substances.
It should be taken into account that for a period of up to 3 months, when using the drug, the activity of attenuated live vaccines against rubella, measles, chickenpox and mumps is reduced.
Analogs
Analogues of Immunoro Kedriona are: HyperROU S / D, KamROU, Partobulin SDF, Resonative, Rezogam N.
Terms and conditions of storage
Store in a place protected from light at temperatures up to 25 ° C. Keep out of the reach of children. Do not freeze.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Immunoro Kedrione
Reviews of Immunoro Kedrione are mostly positive. It is noted for its low cost in comparison with drugs from a similar group, easy portability and a convenient form of release that does not require special storage conditions. There are also reports of a lack of awareness of possible side effects.
Price for Immunoro Kedrion in pharmacies
The price of Immunoro Kedrion (1 bottle) varies from 3350 to 3730 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!
