Immunoglobulin human is an immunologically active protein fraction separated from human plasma or define equipoise donor sera tested for the absence of antibodies to human immunodeficiency virus , hepatitis C virus and hepatitis B surface antigen . The active ingredient of the drug is the immunoglobulin G, containing incomplete define equipoise. It is used to prevent isoimmunization Rh-negative mother having been exposed to Rh-positive blood of the fetus at birth Rh-positive baby, abortion (both spontaneous and artificial), in the case of amniocentesis or receiving abdominal trauma during pregnancy. It reduces the frequency of Rh isoimmunization of mother at the introduction of the drug within 72 hours of birth at term Rh-positive baby Rh-negative mother.
The maximum concentration of antibody in the blood after 24 hours after intramuscular injection of the human immunoglobulin antirezus Rho (D). Period half-life of a human define equipoise immunoglobulin antirezus Rho (D) from the body – 4-5 weeks.
- first pregnancy and the birth of a Rhesus positive baby;
- artificial or spontaneous abortion;
- when interrupted ectopic pregnancy;
- under the threat of termination of pregnancy;
- during amniocentesis and other procedures associated with the risk of fetal blood entering the mother’s bloodstream;
- Rh-positive blood affiliation of her husband;
- Receive abdominal trauma;
2.Treatment of Rh-negative patients in the case of transfusion of Rh-positive blood, or products containing red blood cells.Contraindications
- Rh-negative puerperal sensitized define equipoise antigen Rho (D), in which the serum antibody found Rh;
- Rh-positive patients.Dosing and Administration
The drug is administered by intramuscular injection.
Prior to administration of the drug vial is maintained for 2 hours at room temperature (18-22 ° C). To avoid the formation of foam formulation in a syringe needle with a wide clearance. The preparation of opening the bottle must not be stored. The drug is administered only intramuscularly once: postpartum women – within the first 48-72 hours after birth, when the artificial termination of pregnancy – immediately after the operation is completed. One dose – 300 mg at a titer of 1: 2000 or with 600 ug titer of 1: 1000. You can not be administered intravenously. Human Immunoglobulin antirezus Rho (D) are administered a single dose of 300 micrograms (1500 ME), sometimes two doses of 600 micrograms (3000 ME) intramuscularly once: puerperas – within 72 hours after birth; when abortion -neposredstvenno after surgery.You must meet the following criteria:
1. The mother must be Rh-negative and should not already be sensitized to the Rho factor (D).
2. Her child must be Rh positive.
If the drug is administered before delivery, it is essential that the mother received another dose of the drug after the birth of a Rhesus positive baby within 72 hours after birth. If it is determined that the father Rh-negative, there is no need to inject the drug.Pregnancy and other conditions associated with pregnancy and childbirth:
1. For the prevention of post-partum should introduce a single dose of 300 micrograms (1500 ME) product KamROU preferably within 72 hours after birth. The need for a given dose in the case of passing the full term of pregnancy can be different depending on the volume of fetal blood trapped in maternal circulation. In a dose of 300 micrograms (1500 ME) contains a sufficient amount of antibody to prevent sensitization to the Rhesus factor, if the amount of fetal erythrocytes caught in maternal blood flow does not exceed 15 ml. In those cases when it is assumed from entering the bloodstream larger volume of fetal erythrocytes mother (over 30 ml of whole blood or in excess of 15 ml erythrocytes), carry count of fetal erythrocytes by using an approved laboratory techniques (for example, a modified method of acid washing-staining Klyayhaueru and Bethke ) to set the required dose of immunoglobulin. The calculated amount of fetal red blood cells caught in the mother’s bloodstream, divided into 15 ml and get the number of doses of the drug KamROU to be entered. If the calculated dose is obtained fraction rounded number of doses up to the next whole number upwards (for example, when receiving the result of 1,4 type 2 doses of 600 mcg (3000 ME product)).
2. For the prevention of prenatal about the 28th week of pregnancy, the drug is administered one dose of 300 micrograms (1500 ME). This was sure to introduce another dose of 300 micrograms (1500 ME), preferably within 48-72 hours after birth, if the child would be born Rh positive.
3. In the case of continuing pregnancy after an abortion threat at any stage of pregnancy is recommended that a single dose of 300 micrograms (1500 ME). If the mother is suspected entering the bloodstream over a 15 ml fetal erythrocytes need to change the dose, as described in the above paragraph 1.
4. After a miscarriage, abortion or ectopic pregnancy interruption of pregnancy over 13 weeks, it is recommended to introduce a dose of 300 micrograms (1500 ME). If suspected of entering the bloodstream mother more than 15 ml of fetal red blood cells, it is necessary to change the dose, as described in paragraph 1. If pregnancy is interrupted for a period of less than 13 weeks, possibly single use mini-dose KamROU (approximately 50 micrograms (250 ME)).
5. After amniocentesis or at 15-18 weeks of gestation, or during the third trimester of pregnancy, or in the preparation of injury in the abdominal cavity during the second and / or third trimester recommended to introduce a dose of 300 micrograms (1500 ME). If suspected of entering the bloodstream mother more than 15 mL of red blood cells, it is necessary to change the dose, as described in paragraph 1. If the injury of the abdominal cavity, amniocentesis, or other adverse circumstance requires the introduction of the drug in the period 13-18 weeks of pregnancy, you must enter another dose of the drug 300 g (1500 ME) in the period 26-28 weeks. To maintain protection throughout pregnancy should not be allowed concentration level of falling passively derived antibodies to Rho (D) below the level required to prevent the immune response to Rh-positive red blood cells of the fetus. The half-life period of human immunoglobulin antirezus Rho (D) is 28-35 days. In any case, the dose should be administered 48-72 hours after birth – if the baby is Rh-positive. If the birth occurs within 3 weeks after the last dose, postpartum dose may be canceled (except when hit more than 15 mL of red blood cells of the fetus in the mother’s blood stream).
Side effects Skin reactions: discomfort, swelling and redness at the injection site, hyperthermia up to 37.5 ° C (during the first day after administration). On the part of the digestive system: dyspepsia.Allergic reactions: seldom – (in case of hypersensitivity, including at failure IgA) – allergic reactions (up to anaphylactic shock).
overdose cases in Rh-negative women are not described.
The interaction with other drugs
Therapy immunoglobulin may be combined with other drugs, including with antibiotics. Immunization of women with live vaccines should be carried out not earlier than 3 months after the introduction of immunoglobin antirezus.
Children born to women who received human immunoglobulin antirezus Rho (D) before birth, at birth is possible to obtain a weakly positive results of tests for the presence of direct antiglobulin. The maternal serum antibodies can be detected to Rho (D), produced by a passive, if screening tests for antibodies produced after prenatal or postnatal administration to the human immunoglobulin Rho (D). Not suitable for the use of drugs in vials and syringes with a violation of the integrity or marking a change of physical properties (color change, turbidity of the solution, the presence of non-separating flakes), with an expired shelf life, if not properly stored.
If it is determined that the Rho (D) father – negative administered drug is not necessary. After administration, patients should be monitored for 30 minutes. Medical offices must have a means of anti-shock therapy.
solution for intramuscular injection of 150 mcg / ml (750 IU / ml).
In 2 ml solution for intramuscular injection in vials colorless hydrolytic glass (the USP) Type I, sealed with rubber rubber stoppers and crimped aluminum caps with plastic cover (flip-off ). 1 bottle with instruction on use and needle filter (in sterile packaging made ??of paper and PVC) is placed in a cardboard box.
In the dark place at a temperature between 2 and 8 ° C. Do not freeze.
Keep out of the reach of children.
Do not use beyond the expiration date.
Conditions of supply of pharmacies
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