Active substanceImmunoglobulin human antiresus Rho (D)Immunoglobulin human antiresus Rho (D)
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  • Dosage form: & nbspRAsterol for intramuscular injection.
    Composition:

    1 ml of the solution contains:

    human immunoglobulin antiresus Rho (D) - 625 ME;

    atExcipients: glycine, sodium acetate, sodium chloride, water for injection.

    Description:

    Transparent or slightly opalescent solution from colorless to pale yellow or light brown in color.

    Pharmacotherapeutic group:immunoglobulin
    ATX: & nbsp

    J.06.B.B.01   Immunoglobulin human antiresus Rho (D)

    Pharmacodynamics:Resonative is a human immunoglobulin antiresus Rho(D), which prevents rhesus sensitization in Rhabout(D) -negative body when exposed to it Rhabout(D) -positive blood.
    Pharmacokinetics:

    The appearance of antibodies in the blood occurs approximately 20 minutes after intramuscular injection, the maximum concentration of antibodies in the blood plasma is established within 2-3 days.The half-life of human immunoglobulin antiresus Rho(D) at a normal level IgG is 3-4 weeks. IgG and complexes IgG are destroyed by cells of the reticuloendothelial system.

    Indications:

    Prevention of Rh-immunization in Rhesus-negative pregnant women not sensitized to Rho(D)-antigeny (ie, those who did not develop Rh antibodies):

    - Prenatal prophylaxis:

    • Scheduled antenatal care;
    • Prevention for various complications: ectopic pregnancy, artificial or spontaneous abortion, vesicular dribbling, intrauterine fetal death, transplacental hemorrhage, amniocentesis, chorionic biopsy or other obstetric procedures (for example, an external obstetric turn), when receiving an abdominal injury during pregnancy .

    - Postpartum prevention

    • Birth of Rh-positive child.

    Treatment of Rh-negative patients in case of transfusion of Rh-positive blood or other preparations containing red blood cells.

    Contraindications:

    Hypersensitivity to the components of the drug.

    Dosing and Administration:

    Resonative is administered intramuscularly.Before the introduction of the ampoule with the drug should be brought to room temperature or body temperature. The drug is not intended for intravenous administration (the risk of anaphylactic shock). It should be administered only intramuscularly. To do this, after inserting the needle into the muscle, you need to feed 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 injected subcutaneously. Place the injection should be gently massaged and put a compress.

    The dose of immunoglobulin anti- Rho(D) is determined in accordance with the amount of Rh positive fetal red blood cells that have entered 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 approximately 50 ME (10 μg) of the immunoglobulin anti-D.

    When prenatal care once injected 1250 ME (250 mcg) of the drug at the 28th-30th week of pregnancy; or injected at 1250 ME (250 mcg) twice - at the 28th and 34th weeks of pregnancy.

    When postpartum prophylaxis the drug is administered once in a dose of 1250 ME (250 μg) 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 prevention in the case of various complications of pregnancy and childbirth the drug is administered once - in a dose of 625 ME (125 mcg) with a gestation period of up to 12 weeks or at a dose of 1250 ME (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 chorionic biopsy once injected 1250 ME (250 μg) of the drug.

    If it is suspected that fetomaternal bleeding is more than 4 ml (in case of fetal / newborn or fetal death),it is necessary to estimate its value by an appropriate method, for example, by the acid leaching method by Kleichauer-Bethke, which determines fetal hemoglobin, or by the method of stream cytometry, which identifies Rh-positive red blood cells. The additional dose of Resonative is calculated in accordance with the ratio 100 ME (20 μg) of the preparation per 1.0 ml of fetal erythrocytes.

    When Rhesus-incompatible blood transfusions the recommended dose is 100 ME (20 μg) of the immunoglobulin anti-Rho(D) in 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 immunoglobulin anti-Rho(D) until their complete elimination.

    In the case of transfusion of large quantities of incompatible blood or erythrocyte mass, a maximum dose of 15,000 ME (3 000 μg) of the drug, 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 effects:

    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%).

    From the immune system: rarely - hypersensitivity reactions, rarely - anaphylactic shock.

    From the nervous system: infrequently - headache.

    From the side of the cardiovascular system: rarely - tachycardia, lowering blood pressure.

    From the gastrointestinal tract: rarely - nausea, vomiting.

    From the skin side: rarely - erythema, itching.

    From the musculoskeletal system: rarely - Arthralgia.

    Reactions at the site of administration: rarely - soreness, erythema, swelling, denseness, rash, itching.

    Other: infrequently - fever, malaise, chills, tenderness at the injection site.

    Overdose:

    Cases of overdose are not marked. Patients who received large doses of the drug due to transfusion of Rhesus-incompatible blood should be under dynamic observation, including monitoring of biochemical parameters, due to the risk of hemolytic complications.

    Interaction:

    Resonant 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 carried out no earlier than 3 months after the last injection of immunoglobulin anti-Rho(D), since it is possible to reduce the effectiveness of vaccination.

    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) can affect the results of some serological tests, for example, the antiglobulin test (Coombs reaction), especially in Rh-positive newborns whose mothers received prenatal prophylaxis.

    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 Rho(D) -antigen.

    Mud solutions and solutions containing a sediment can not be used.

    When prescribing the drug, it is necessary to register the serial number of the drug in the patient's medical history or record.

    After administration of the drug, patients should be monitored for 20 minutes.

    Even in those patients who have previously tolerated treatment with human immunoglobulin, in rare cases, may develop a drop in blood pressure with anaphylactic reaction. 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-Rho(D). Patients should be informed of the early signs of hypersensitivity such as hives, generalized skin rash, chest tightness, wheezing, reduction in 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 contains a small amount IgA, so the doctor needs to assess the relationship between the risk of developing hypersensitivity reactions and the benefits of therapy in persons with a deficit IgA. In patients with a deficit IgA the appearance IgA-antibodies with the development of anaphylactic reactions after administration of the preparation containing IgA.

    In the case of a transfusion of Rh-incompatible blood, when large doses of anti-Rho(D) immunoglobulin, it is necessary to carefully monitor the patient 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. Nevertheless, when using drugs produced from human blood or plasma, the possibility of transferring infectious agents is not completely excluded. 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."

    Effect on the ability to drive transp. cf. and fur:

    There was no evidence of the effect of the drug on the ability to drive vehicles and work with mechanisms.

    Form release / dosage:

    Solution for intramuscular injection, 625 IU / ml.

    Packaging:

    1 ml of solution in a colorless glass ampoule (type I, Hept. F.) with a red dot, 1 ampoule per plastic blister pack, 1 plastic blister pack, along with instructions for use, put in a cardboard box.

    2 ml of the solution in a colorless glass ampoule (type I, Hept. F.) with a red dot, 1 ampoule per plastic blister pack, 1 plastic blister pack, along with instructions for use, placed in a cardboard box.

    2 ml of the solution in a colorless glass ampoule (type I, Hept. F.) with a red break point, 5 ampoules per plastic blister pack, 2 plastic blister packs, along with instructions for use, are placed in a cardboard box.

    Storage conditions:

    Store at a temperature of 2 to 8 ° C, in a place protected from light.

    Keep out of the reach of children.

    Shelf life:

    2.5 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000970/10
    Date of registration:15.02.2010 / 04.10.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:Octapharma ABOctapharma AB Sweden
    Manufacturer: & nbsp
    Representation: & nbspOKTAPHARMA NORDIC AB OKTAPHARMA NORDIC AB Sweden
    Information update date: & nbsp17.12.2016
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