GiperROU C / D

Active material: immunoglobulin G
When ATH: J06BB01
CCF: Preparation, affecting the immune system. Immunoglobulin
ICD-10 codes (testimony): P55
When CSF: 14.05
Manufacturer: TALECRIS BIOTHERAPEUTICS Inc. (United States)

Pharmaceutical form, composition and packaging

The solution for the / m clear or slightly opalescent, a colorless or slightly yellow, without foreign impurities; during storage may be the appearance of a slight precipitate, disappearing with shaking drug at 20 ± 2 ° C.

Excipients: glycine, sodium chloride, sodium cholate, TNBF, water d / and.

1 dose (1500 ME) – disposable syringes with needle (1) – packs cardboard.

Pharmacological action

IMMUNOLOGICALS. It is an immunologically active protein fraction, isolated from human plasma or serum of donors, tested for the absence of antibodies to Human Immunodeficiency Virus (HIV-1, HIV-2), hepatitis C virus and the surface antigen of hepatitis B virus.

The active component of the drug is an immunoglobulin G, incomplete containing anti-Rh₀(D)-antibodies. Prevent isoimmunization in Rh-negative woman's body, exposed to Rh-positive blood as a result of fetal blood flow in the mother's blood stream at the birth of a Rhesus positive baby, abortion (both spontaneous, and artificial), in the case of amniocentesis, or upon receipt of the abdominal cavity trauma during pregnancy.

With the introduction of human immunoglobulin antirezus Rh₀(D) during 72 hours after birth fully nurtured Rh₀(D)-Rh positive baby₀(D)-negative mother frequency of Rh isoimmunization decreases.

Pharmacokinetics

Absorption

C_max antibodies in the blood achieved through 24 no.

Deduction

T_1/2 antibodies from organism is 4-5 weeks.

Testimony

The drug is indicated for use in Rh-negative women, not sensitized to the Rh antigen₀(D) (ie. in the absence of Rh antibodies) provided:

- pregnancy and the birth of a Rhesus positive baby;

- artificial and spontaneous abortion;

- when interrupted ectopic pregnancy;

- under the threat of termination of pregnancy at any stage;

- after amniocentesis and other procedures, associated with the risk of fetal blood getting into the mother's bloodstream, as well as in the preparation of abdominal injury.

Dosage regimen

The drug is introduced into / m 1 dose (1500 ME) or 2 dose (3000 ME) single: puerpera – during 72 hours after childbirth, when abortion – immediately after the operation. You must comply with the following criteria:

- the mother must be Rh-negative and should not already be sensitized to the Rh factor₀(D);

- her child must be Rh-positive.

If the drug is administered before delivery, important, the mother received another 1 dose after the birth of a Rhesus positive baby during 72 hours after childbirth. If you set, that his father – Rh-negative, there is no need to inject the drug.

Before the introduction of syringes with the drug stand for 2 hours at room temperature (20±2°C). For, to avoid formation of foam, drug in a syringe needle with a wide lumen.

The drug should not be administered in /!

For prevention of post-partum enter 1 dose (1500 ME) preparation GiperROU C / D in the first 72 hours after childbirth. The need for specific dose in the case of completing a full term of pregnancy is different depending on the volume of blood of the fetus, trapped in the mother's bloodstream. IN 1 dose (1500 ME) It contains a sufficient amount of antibody to prevent sensitization to the Rhesus factor, if the amount of fetal erythrocytes, caught in the bloodstream, less than 15 ml. Where, when it is expected to hit the bloodstream mother larger volume of fetal erythrocytes (above 30 ml of whole blood or above 15 ml erythrocytes), should hold count of fetal erythrocytes by using an approved laboratory technique (eg, modified method of acid washing-staining and Bethke Klyayhaueru), to establish the appropriate dose of the drug. The calculated volume of fetal erythrocytes, caught in the mother's bloodstream, divided into 15 mL, and number of doses prepared GiperROU C / D, which you must enter. If it is assumed the presence of more than 15 ml fetal erythrocyte or dose calculations resulting fraction obtained, number of doses should be rounded to the next integer in the direction of increasing, eg, when receiving the result 1.4 enter 2 dose (3000 ME) product.

For prevention in the prenatal period enter 1 dose (1500 ME) about 28 weeks of pregnancy. This was sure to enter another 1 dose (1500 ME), preferably for 72 hours after childbirth, if the unborn child will be Rh-positive.

In case of continued pregnancy after an abortion threat at any stage of pregnancy should be introduced 1 dose (1500 ME) product. If suspected of entering the mother's bloodstream over 15 ml fetal erythrocytes, you need to change the dose (as stated above).

After spontaneous abortion, abortion or ectopic pregnancy interruption of pregnancy more 13 weeks It recommended the introduction of 1 dose (1500 ME) product. If suspected of entering the mother's bloodstream over 15 ml fetal erythrocytes, you need to change the dose (as stated above). If pregnancy is terminated at less than 13 weeks, perhaps a single administration of small doses GiperROU-C / D (about 250 ME).

after the amniocentesis at 15-18 weeks gestation, or during the III trimester of pregnancy, or in the preparation of abdominal trauma during II and / or III trimester enter 1 dose (1500 ME) product. If suspected of entering the mother's bloodstream over 15 ml erythrocytes, you need to change the dose, as described above. If the injury of abdominal organs, amniocentesis or other adverse circumstance requires administration at time of preparation 13-18 weeks of pregnancy, enter another 1 dose (1500 ME) on term 26-28 weeks.

To maintain protection throughout pregnancy can not allow the concentration level fall passively derived antibodies to Rh₀(D) below the level, required to prevent the immune response to Rh-positive erythrocytes. T_1/2 Rh immunoglobulin human antirezus₀(D) is 23-26 days. In any case the dose to be administered over 72 hours after childbirth, if the child is Rh positive. If the birth occurs during 3 weeks after the last dose, postpartum dose may be canceled (except, when it came to the mother's bloodstream over 15 ml fetal erythrocytes).

Side effect

Maybe: hyperemia, fever up to 37.5 ° C (during the first day after administration), dyspepsia.

In some cases,: in patients with altered reactivity (incl. the insufficiency of immunoglobulin A) may develop allergic reactions of various types (incl. anaphylactic shock).

Contraindications

- Rh-positive woman in childbirth;

- Rh-negative puerperal, sensitized to the Rh antigen₀(D) (serum which is found Rh antibodies).

- Hypersensitivity to the drug.

Prohibited drug administration to newborns.

Cautions

Children, born of women, human immunoglobulin are prepared antirezus Rh₀(D) before giving birth, at birth may receive little positive results of tests for the presence of direct antiglobulin. The maternal serum can be detected antibodies to Rh₀(D), obtained by passive, If screening tests for antibodies produced after prenatal or postnatal administration of human immunoglobulin to Rh₀(D).

Immunization of women with live vaccines should be carried out not earlier than 3 months after administration.

Due to the possibility of allergic reactions in patients for 30 min after drug administration must be supervised. In room, where the drug is administered, must be a means of anti-shock therapy. With the development of anaphylactic reactions used antihistamines, GCS and alpha-adrenergic agonists.

Drug therapy GiperROU C / D can be combined with other drugs, in particular with antibiotics.

Overdose

The cases of drug overdose GiperROU S / D is not known.

Drug Interactions

Drug interaction preparation GiperROU S / D is not described.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in the dark, inaccessible to children at 2 ° to 8 ° C; Do not freeze. Shelf life - 3 year.

No preparation suitable for use in syringes with compromised integrity or marking, when changing the physical properties of (discoloration, pomutnenye of the solution, the presence of non-separating flakes), if expired, if not properly stored.

Shipping performed by any kind of covered transport at a temperature of from 2 ° to 8 ° C.