Composition, form of production and packaging
The solution for the / m introduction is clear or slightly opalescent, from pale yellow to light brown in color.
1 ml
immunoglobulin human antiresus Rh 0 (D) 625 IU
[PRING] glycine, sodium acetate, sodium chloride, water d / and.
1 ml - ampoules of colorless glass (1) - plastic blister packs (1) - cardboard packs.
The solution for the / m introduction is clear or slightly opalescent, from pale yellow to light brown in color.
1 ml of 1 amp.
human immunoglobulin antiresus Rh 0 (D) 625 IU 1250 IU
[PRING] glycine, sodium acetate, sodium chloride, water d / and.
2 ml - ampoules of colorless glass (1) - plastic blister packs (1) - cardboard packs.
2 ml - ampoules of colorless glass (5) - plastic blister packs (2) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
PHARMACHOLOGIC EFFECT
Resonative В® is an immunoglobulin of the human antiresus Rh 0 (D), which prevents rhesus sensitization in the Rh 0 (D) -negative body when Rh 0 (D) -positive blood acts on it.
PHARMACOKINETICS
The appearance of antibodies in the blood is observed approximately 20 minutes after the / m administration, C max of antibodies in the blood plasma is established within 2-3 days.
T 1/2 of the human immunoglobulin Rhres 0 (D) at a normal level of IgG is 3-4 weeks. IgG and IgG complexes are destroyed by cells of the reticuloendothelial system.
INDICATIONS
Prevention of Rhesus Immunization in Rh-negative pregnant women not sensitized to Rh 0 (D) -antigen (ie, those who did not develop Rh antibodies):
- prenatal prophylaxis: planned antenatal prevention and prophylaxis in case of various complications (including ectopic pregnancy, artificial or spontaneous abortion, vesicular dribbling, intrauterine fetal death, transplacental bleeding, amniocentesis, chorionic biopsy or other obstetric manipulations (for example, external obstetric turn), when injuring the abdominal organs during pregnancy);
- postpartum prophylaxis: the birth of a Rh-positive child.
Treatment of Rh-negative patients in case of transfusion of Rh-positive blood or other preparations containing red blood cells.
DOSING MODE
Resonative В® is introduced only in / m. Before the beginning of the administration of the ampoule with the drug should be heated to room temperature or body temperature.
The drug is not intended for intravenous administration (the risk of developing anaphylactic shock). To prevent in / in the introduction, after inserting the needle into the muscle, apply the syringe piston slightly back to make sure there is no blood in the needle. In case of erroneous intravenous administration, the duration of observation of the patient should be at least 1 hour.
If it is necessary to introduce a large volume of the drug (more than 5 ml), the dose should be divided into several parts administered separately, to different injection zones.
When hemorrhagic disorders, when intramuscular injections are contraindicated, the drug can be administered SC. Place the injection should be gently massaged and put a compress.
The dose of immunoglobulin anti-Rh 0 (D) is determined in accordance with the amount of Rh positive fetal erythrocytes that have got into the mother's bloodstream.Calculation of the dose is based on the fact that 0.5 ml of Rhesus positive red blood cells or 1 ml of Rh-positive blood is neutralized by approximately 50 IU (10 Ојg) of anti-D immunoglobulin.
When conducting prenatal prophylaxis, 1250 IU (250 mcg) of the drug are injected once at the 28th and 30th week of pregnancy; or injected at 1250 IU (250 Ојg) twice - at the 28th and 34th weeks of pregnancy.
When conducting postpartum prophylaxis, the drug is administered once in a dose of 1250 IU (250 Ојg) as quickly as possible within 72 hours after delivery. If after the delivery more than 72 hours have passed, do not give up the drug, and enter it as soon as possible. The drug must be administered after delivery, despite its use in the prenatal period, and also, despite the presence of residual antirezus antibodies in the mother serum.
When carrying out prophylaxis in the case of various complications of pregnancy and childbirth, the drug is administered once - at a dose of 625 IU (125 mcg) at the gestational age of up to 12 weeks or at a dose of 1250 IU (250 mcg) after the 12th week of pregnancy. The drug should be administered as soon as possible within 72 hours. If necessary, the drug should be repeated every 6-12 weeks throughout the pregnancy.
After amniocentesis and chorion biopsy, 1250 IU (250 Ојg) of the drug are administered once.
If it is suspected that fetomaternal bleeding is more than 4 ml (in case of fetal / newborn or fetal death), its value should be assessed by the appropriate method, for example, by acid washout according to Kleichauer-Betke, determining fetal hemoglobin, or by flow cytometry, identifying Rhesus-positive red blood cells. Additional dose of Resonative is calculated in accordance with the ratio of 100 IU (20 Ојg) of the drug per 1 ml of red blood cells of the fetus.
In the case of a Rh-incompatible blood transfusion, the recommended dose is 100 IU (20 Ојg) of anti-Rh 0 (D) immunoglobulin per 2 ml of Rh-positive blood or 1 ml of erythrocyte mass. To determine the dose, it is advisable to consult a transfusiologist. Every 48 hours, the presence of Rh-positive erythrocytes in the recipient should be monitored and the need for an additional dose of anti-Rh 0 (D) immunoglobulin to be completely eliminated should be determined. In the case of transfusion of large quantities of incompatible blood or erythrocyte mass, the maximum dose of 15,000 IU (3,000 Ојg) of the drug is considered sufficient, despite the fact that the volume of transfused Rhesus positive red blood cells could be more than 300 ml. Large doses of the drug should be administered within a few days.
SIDE EFFECT
Frequency of occurrence of undesirable reactions is classified as follows: very often (> 10%), often (? 1% - <10%), infrequently (? 0.1% - <1%), rarely (? 0.01% - <0.1%) , very rarely (<0.01%).
On the part of the immune system: rarely - hypersensitivity reactions, very rarely - anaphylactic shock.
From the nervous system: infrequently - a headache.
From the cardiovascular system: rarely, tachycardia, lowering blood pressure.
From the digestive system: rarely - nausea, vomiting.
Dermatological reactions: rarely - erythema, itching.
From the musculoskeletal system: rarely - arthralgia.
Reactions in the injection site: rarely - tenderness, erythema, swelling, tightness, rash, itching.
Other: infrequent - fever, malaise, chills, tenderness at the injection site.
CONTRAINDICATIONS
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
It is used according to the indications.
SPECIAL INSTRUCTIONS
When used in the postpartum period, the drug is prescribed only to the parturient woman; the drug is not intended for administration to newborns.
The drug is not used in Rh-positive patients and in patients already immunized to Rh 0 (D) -antigen.
Mud solutions and solutions containing a sediment can not be used.
When prescribing a drug, it is necessary to register the serial number of the drug in the patient's history or medical record.
After administration of the drug, patients should be monitored for 20 minutes.
Even in those patients who previously well tolerated treatment with human immunoglobulin, in rare cases, a sharp drop in blood pressure with an anaphylactic reaction can develop. In case of an allergic or anaphylactic reaction, the drug should be discontinued immediately.
Reactions of true hypersensitivity develop rarely, but allergic reactions to immunoglobulin anti-Rh 0 (D) can be observed. Patients should be informed of early symptoms of hypersensitivity such as urticaria, generalized skin rash, chest tightness, wheezing , lowering of blood pressure and anaphylaxis. Treatment depends on the cause and severity of the reaction of hypersensitivity. In the case of shock, treatment is performed according to the general rules of anti-shock therapy.
Resonative В® contains a small amount of IgA, so the doctor needs to assess the relationship between the risk of developing hypersensitivity reactions and the benefits of therapy in individuals with IgA deficiency. In patients with IgA deficiency, the appearance of IgA antibodies is possible with the development of anaphylactic reactions after the administration of the preparation containing IgA.
In case of transfusion of Rhesus-incompatible blood, when it is required to administer large doses of anti-Rh 0 (D) immunoglobulin, the patient should be carefully monitored because of the risk of developing a hemolytic reaction.
Standard measures to prevent infections caused by the use of drugs derived from human blood or plasma include selection of donors, testing of individual portions and pools of plasma for specific markers of infection, and the inclusion of effective measures to inactivate / eliminate viruses in the production process. These measures are considered effective against envelope viruses - HIV, hepatitis B and hepatitis C viruses, against the non-enveloped hepatitis A virus, and to a lesser extent for parvovirus B19. However, with the use of drugs produced from human blood or plasma, the possibility of transferring pathogens of infectious diseases can not be completely ruled out. This also applies to unknown or newly identified viruses and other pathogenic microorganisms.
The drug contains less than 1 mmol (23 mg) of sodium in 1 ml, and therefore is "free of sodium."
Impact on the ability to drive vehicles and manage mechanisms
There was no evidence of the effect of the drug on the ability to drive vehicles and work with mechanisms.
OVERDOSE
Cases of overdose are not marked.
Patients who received large doses of the drug due to transfusion of Rh-incompatible blood should be under dynamic observation, including monitoring of biochemical parameters, due to the risk of hemolytic complications.
DRUG INTERACTION
Resonative В® should not be mixed with other drugs, it should be administered as a separate injection.
Immunization with live viral vaccines (measles, mumps, rubella) should be performed no earlier than 3 months after the last administration of the anti-Rh 0 (D) immunoglobulin, since a decrease in the effectiveness of vaccination is possible.
After the introduction of immunoglobulin, a temporary increase in the level of various antibodies is possible, which can lead to false positive results when using serological diagnostic methods.
Passive transfer of antibodies to erythrocyte antigens (A, B, D) may affect the results of some serological tests, for example, the antiglobulin test (Coombs reaction), especially in Rh-positive newborns whose mothers received prenatal prophylaxis.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a protected from light, out of reach of children at a temperature of 2 В° to 8 В° C. Shelf life - 2.5 years.
