Instruction for use: HyperRHO SD

Dosage form: Solution for intramuscular injection

Active substance:

Immune globulin human antirhesus Rho[D]

ATX

J06BB01 Human immunoglobulin Rh rresistant Rho (D)

Pharmacological group

Immunoglobulins

Nosological classification (ICD-10)

O08 Complications caused by abortion, ectopic or molar pregnancy

O08.8 Other complications caused by abortion, ectopic and molar pregnancy

O20.0 Threatening abortion: Threatening abortion; Miscarriage aborting; A spastic condition with a risk of abortion; Threatening miscarriage in the first trimester of pregnancy; Threat of abortion; Threatening abortion; The threat of spontaneous miscarriage; A threatening spontaneous miscarriage

O36.0 Rhesus immunization, requiring the provision of medical care to the mother

O41.9 Disturbance of amniotic fluid and membranes, unspecified: Amniocentesis

O75 Other complications of labor and delivery, not elsewhere classified

O75.8 Other specified complications of labor and delivery

O90.8 Other complications of the postpartum period, not elsewhere classified: Lochiometer; Pyelonephritis after childbirth

S37 Pelvic injuries: Trauma to the genitourinary system

S37.6 Injury of the uterus

Z36.2 Another type of antenatal screening based on amniocentesis: Amniography

Composition and release form

Solution for intramuscular injection 0.5 ml

Immunoglobulin G 1500 IU

Excipients: glycine, water for injection

In a disposable syringe with a 1 ml needle; In a pack of cardboard 1 syringe.

Description of dosage form

Solution for the IM introduction - transparent or slightly opalescent, colorless or slightly yellow, without foreign inclusions; In the course of storage, a slight deposit may appear, disappearing when the preparation is shaken at a temperature of (20 ± 2) ° C.

Characteristic

Immunological preparation.

Pharmacodynamics

It is an immunologically active protein fraction isolated from human plasma or donor sera tested for the absence of antibodies to the human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus and the surface antigen of the hepatitis B virus.

The active component of the preparation is immunoglobulin G, which contains incomplete anti-Rh0 (D) -antibodies. Prevents isoimmunization in a Rh-negative organism of a woman exposed to Rh-positive blood as a result of fetal blood flow into the bloodstream of the mother at the birth of a Rh-positive child, abortion (both spontaneous and artificial), in the case of an amniocentesis or an abdominal injury Cavity during pregnancy.

With the introduction of human immunoglobulin, the antiresus Rh0 (D) within 72 hours after the birth of the fully endured Rh0 (D) -positive baby Rh0 (D) -negative mother, the frequency of Rhesus isoimmunization is reduced.

Pharmacokinetics

Suction. Cmax antibodies in the blood are reached after 24 h.

Excretion. T1 / 2 antibody from the body is 4-5 weeks.

Indications of the preparation HyperRHO SD

The drug is indicated for use in Rh-negative women not sensitized to the Rh0 (D) antigen (ie, in the absence of Rh antibodies) provided:

Pregnancy and the birth of a Rh-positive child;

With artificial and spontaneous abortion;

When an ectopic pregnancy is interrupted;

With the threat of termination of pregnancy at any time;

After the amniocentesis and other procedures associated with the risk of getting fetal blood into the mother's bloodstream, as well as when getting an abdominal injury.

Contraindications

Hypersensitivity to the drug;

Rh-positive puerperas;

Rh-negative puerperas sensitized to the Rh0 (D) antigen (in the serum of which Rh antibodies were detected).

Prohibited the introduction of the drug to the newborn.

Side effects

Possible: hyperemia, an increase in body temperature to 37.5 ° (during the first day after the administration), dyspeptic phenomena.

In some cases, allergic reactions of various types (including anaphylactic shock) can develop in patients with altered reactivity (including immunoglobulin A deficiency).

Interaction

Drug interaction of the preparation HyperROU C / D is not described.

Dosing and Administration

IM. 1 dose (1500 IU) or 2 doses (3000 IU) once: the puerperium - within 72 hours after birth, with the termination of pregnancy - immediately after the termination of the operation.

The following criteria must be observed:

- the mother should be Rh-negative and should not already be sensitized to the Rh0 (D) factor;

- her child should be Rh-positive.

If the drug is administered before the birth, it is important that the mother received another 1 dose of the drug after the birth of the Rh-positive child within 72 hours after delivery. If it is determined that the father is Rh-negative, it is not necessary to administer the drug.

Before administration, the syringes with the drug are held for 2 hours at room temperature (20 ± 2 ° C). In order to avoid the formation of foam, the drug is drawn into the syringe with a needle with a wide lumen.

The drug should not be administered IV.

For prophylaxis in the postpartum period, one dose (1500 IU) of the HyperROU S / D preparation should be administered within the first 72 hours after delivery. The need for a certain dose in the case of the passage of the full term of pregnancy varies depending on the volume of fetal blood that has entered the mother's bloodstream. A 1 dose (1500 IU) contains enough antibodies to prevent sensitization to the Rh factor if the volume of red blood cells in the bloodstream does not exceed 15 ml. In cases where the mother of a larger volume of fetal erythrocytes (more than 30 ml of whole blood or more than 15 ml of erythrocytes) is expected to enter the bloodstream of the mother, the fetal erythrocytes should be counted using an approved laboratory procedure (for example, the modified acid washing-staining method according to Kleichauer and Betke) , To establish the necessary dose of the drug. The calculated volume of fetal erythrocytes caught in the mother's bloodstream is divided into 15 ml and the number of doses of the HyperROU C / D preparation is obtained, which must be entered. If more than 15 ml of fetal erythrocytes are expected or a fractional number is obtained as a result of the calculation of the dose, the number of doses should be rounded up to the next whole number upwards, for example, when receiving the result 1.4, 2 doses (3000 IU) of the drug should be given.

For prevention in the prenatal period, 1 dose of the drug (1500 IU) should be administered approximately at the 28th week of pregnancy. Then it is necessary to introduce another 1 dose (1500 IU), preferably within 72 hours after childbirth, if the born child is Rh-positive.

In case of continuation of pregnancy after occurrence of threat of abortion at any term of pregnancy it is necessary to enter 1 dose (1500 ME) of a preparation. If a mother is expected to enter the bloodstream of more than 15 ml of fetal erythrocytes, the dose should be changed (as indicated above).

After spontaneous abortion, artificial abortion or interruption of ectopic pregnancy at a gestation period of more than 13 weeks, the administration of 1 dose (1500 IU) of the drug is recommended. If a mother is expected to enter the bloodstream of more than 15 ml of fetal erythrocytes, the dose should be changed (as indicated above). If the pregnancy is interrupted for less than 13 weeks, a single dose of HyperROU S / D (approximately 250 IU) may be given once.

After the amniocentesis at the 15-18th week of pregnancy or during the third trimester of pregnancy, or if a trauma of the abdominal cavity is received during the II and / or III trimester of pregnancy, 1 dose (1500 IU) of the drug should be administered. If it is suspected that more than 15 ml of erythrocytes enter the bloodstream of the mother, it is necessary to change the dose as described above. If a trauma of the abdominal organs, amniocentesis or other unfavorable circumstance requires the introduction of the drug at the period of 13-18 weeks of pregnancy, another 1 dose (1500 IU) should be administered at a period of 26-28 weeks.

To maintain protection throughout the pregnancy, the level of passively received antibodies to Rh0 (D) should not fall below the level necessary to prevent an immune response to Rh-positive red blood cells. T1 / 2 human immunoglobulin antiresus Rh0 (D) is 23-26 days. In any case, the dose of the drug should be administered within 72 hours after delivery if the child is Rh-positive. If childbirth occurs within 3 weeks after receiving the last dose, the postpartum dose can be canceled (except in cases where over 15 ml of fetal erythrocytes have entered the bloodstream of the mother).

Overdose

Cases of overdose of HyperROU S / D preparation are not known.

Special instructions

In children born from women who received human immunoglobulin antiresus Rh0 (D) before birth, it is possible to obtain weakly positive results of direct tests for the presence of antiglobulin at birth. In the mother's blood serum, antibodies to Rh0 (D) obtained passively can be detected if antibody screening tests are performed after prenatal or postnatal administration of the human immunoglobulin to Rh0 (D).

Immunization of women with live vaccines should be carried out no earlier than 3 months after the administration of the drug.

In connection with the possibility of developing allergic reactions, patients should be monitored within 30 minutes after the administration of the drug. There should be antishock therapy in the room where the drug is injected. With the development of anaphylactic reactions, antihistamines, glucocorticoids and alpha-adrenomimetics are used.

Therapy with HyperROS C / D can be combined with other drugs, in particular antibiotics.

The preparation is not suitable for use in syringes with broken integrity or marking, with changing physical properties (color, cloudiness of solution, presence of non-breaking flakes), expired shelf life, improper storage.

Transporting is carried out by any kind of covered transport at a temperature of 2 to 8 ° C

Storage conditions of the drug HyperRHO SD

In the dark place at a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of the drug HyperRHO SD

3 years.

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