Package KamRho solution 750IU/ml, vials with needle 2ml

Certificate of conformity (COC) KamRho solution 750IU/ml, vials with needle 2ml

KamRho solution 750IU/ml, vials with needle 2ml

$1.00

Active ingredient:	Human anti-rho immunoglobulin rho (d)
Dosage form:	Solution for injection

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Categories: Immune system, Immunoglobulins, sera, Medication

Description
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Composition

1 ml of solution for intramuscular use contains:

Active ingredient:

human immunoglobulin antiresus Rh0 (D) 750 IU (150 mcg),

excipients:

glycine,

water for injection.

Pharmacological action

CamROW is an immunologically active protein fraction isolated from human plasma or serum from donors tested for the absence of antibodies to human immunodeficiency virus (HIV), hepatitis C virus (anti-HCV) and hepatitis B surface antigen (HBsAg). The active component of the drug is immunoglobulin G, which contains incomplete anti-Rh0 (D) antibodies.

It is used to prevent isoimmunization of a Rh-negative mother who has been exposed to Rh-positive fetal blood during the birth of an Rh-positive child, during abortion (both spontaneous and artificial), in the case of amniocentesis, or when receiving an injury to the abdominal cavity during pregnancy.

Reduces the frequency of Rh-isoimmunization of the mother when the drug is administered within 72 hours after the birth of a full-term Rh-positive child by a Rh-negative mother.

Indications

Prevention of Rh-conflict in Rh-negative women who are not sensitized to the Rh0(D) antigen (i. e., in the absence of Rh-antibodies), provided that:

during amniocentesis and other procedures associated with the risk of fetal blood entering the mother’s bloodstream;
Rh-positive blood of the husband;
the first pregnancy and the birth of an Rh-positive child;
artificial or spontaneous abortion;
ectopic pregnancy termination;
at the risk of termination of pregnancy;
when receiving an abdominal injury.

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

Use during pregnancy and lactation

It is used during pregnancy and after childbirth in accordance with the indications.

Contraindications

hypersensitivity to the components of the drug CamROW;
newborns;
Rh-positive patients;
Rh-negative puerperas, sensitized to the Rh0(D) antigen, in whose blood serum Rh-antibodies were detected.

Side effects

Local reactions:

discomfort, swelling and hyperemia at the injection site.

From the body as a whole:

hyperthermia up to 37.5°C (during the first day after use).

From the digestive system:

dyspepsia.

Allergic reactions:

rarely (with hypersensitivity, including IgA deficiency) – allergic reactions up to anaphylactic shock.

Interaction

Immunization of women with live vaccinesit is recommended to be carried out no earlier than 3 months after the introduction of antiresus immunoglobulin.

Immunoglobulin therapy can be combined with other medications, including antibiotics.

How to take, course of use and dosage

The drug CamROW is administered intramuscularly. Do not inject intravenously.

Before the start of use, ampoules with the drug are kept for 2 hours at room temperature (from 18° to 22°C). To avoid the formation of foam, the drug is typed into the syringe with a needle with a wide lumen. The drug in the opened bottle is not subject to storage.

The drug is administered only intramuscularly, once: to the puerperal woman – during the first 48-72 hours after delivery, in case of artificial termination of pregnancy-immediately after the end of the operation.

One dose is 300 mcg at a titer of 1: 2000 or 600 mcg at a titer of 1: 1000.

Human immunoglobulin antiresus Rh0 (D) is administered one dose of 300 mcg (1500 IU), sometimes two doses of 600 mcg (3000 IU) intramuscularly once: to the puerperal woman – within 72 hours after delivery; in case of termination of pregnancy – immediately after the end of the operation.

The following criteria must be met: :

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

2. Her child must be Rh-positive.

If the drug is administered before delivery, it is essential that the mother receive another dose of the drug after the birth of a Rh-positive child within 72 hours after delivery. If it is established that the father is Rh-negative, there is no need to administer the drug.

Pregnancy and other conditions related to pregnancy and childbirth

For prevention in the postpartum period, a single dose of 300 mcg (1500 IU) of KamRhoPRE should be administered within 72 hours after delivery. The need for a certain dose in the case of passing the full term of pregnancy varies depending on the volume of fetal blood that has entered the mother’s bloodstream. A single dose of 300 mcg (1500 IU) contains a sufficient amount of antibodies to prevent sensitization to the Rh factor, if the volume of fetal red blood cells that have entered the mother’s bloodstream does not exceed 15 ml. In cases where a larger volume of fetal red blood cells is expected to enter the mother’s bloodstream (more than 30 ml of whole blood or more than 15 ml of red blood cells), fetal red blood cells should be counted using an approved laboratory technique (for example, the modified Kleihauer and Bethke acid wash-staining method) to determine the required dose of immunoglobulin. The calculated volume of fetal red blood cells that have entered the mother’s bloodstream is divided by 15 ml and the number of doses of CamROW to be administered is obtained. If the calculated dose results in a fraction, then the number of doses should be rounded up to the next integer (for example, if the result 1.4 is obtained,2 doses of the drug should be administered-600 mcg (3000 ME)).

For prevention in the prenatal period, approximately at the 28th week of pregnancy, a single dose of 300 mcg

(1500 IU) is administered. After that, it is necessary to enter another dose of 300 mcg (1500 IU), preferably within 48-72 hours after delivery, if the baby is Rh-positive.

In case of continuation of pregnancy after the threat of abortion at any time of pregnancy, it is recommended to enter a single dose of the drug 300 mcg (1500 IU). If more than 15 ml of fetal red blood cells are suspected to enter the mother’s bloodstream, the dose should be changed as described in step 1.

A single dose of 300 mcg (1500 IU) is recommended after spontaneous abortion, artificial abortion, or ectopic pregnancy termination if the pregnancy period is longer than 13 weeks. If more than 15 ml of fetal red blood cells are suspected to enter the mother’s bloodstream, the dose should be changed as described in step 1. If the pregnancy is terminated for less than 13 weeks, a single mini-dose of CamROW (approximately 50 mcg (250 IU)) is possible.

After amniocentesis, either at 15-18 weeks of pregnancy, or during the third trimester of pregnancy, or if an abdominal injury occurs during the second and/or third trimester, it is recommended to enter a single dose of 300 mcg (1500 IU). If more than 15 ml of red blood cells are suspected to enter the mother’s bloodstream, the dose should be changed as described in step 1. If an abdominal injury, amniocentesis, or other adverse event requires use of the drug at 13-18 weeks of pregnancy, another dose of 300 mcg (1500 IU) should be administered at 26-28 weeks. To maintain protection throughout pregnancy, the concentration of passively obtained Rh0(D) antibodies should not fall below the level necessary to prevent an immune response to Rh-positive fetal red blood cells. T1 / 2 of human immunoglobulin antiresus Rh0 (D) is 28-35 days. In any case, the dose of the drug should be administered within 48-72 hours after delivery – if the child is Rh-positive. If labor occurs within 3 weeks of receiving the last dose, the postpartum dose can be canceled (except in cases where more than 15 ml of fetal red blood cells have entered the mother’s bloodstream).

Overdose

Cases of overdose in Rh-negative women have not been described.

Special instructions

In the mother’s blood serum, it is possible to detect antibodies to Rh0(D) obtained passively, if antibody screening tests are performed after prenatal or postpartum use of human immunoglobulin to Rh0(D).

Children born to women who received human immunoglobulin antiresus Rh0 (D) prior to delivery may have weakly positive results from direct tests for the presence of antiglobulin at birth.

If the Rh0(D) father is found to be negative, there is no need to administer the drug.

After use of the drug, patients should be monitored for 30 minutes. Medical offices should have anti-shock therapy facilities.

Preparations in vials and syringes with broken integrity or labeling, with changes in physical properties (color change, turbidity of the solution, the presence of non-breaking flakes), with an expired shelf life, with improper storage are not suitable for use.

Form of production

Solution for intramuscular use

Storage conditions

Store in a dark place, at a temperature of 2-8 °C (do not freeze)

Shelf life

2 years

Active ingredient

Human Immunoglobulin antiresus Rho (D)

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

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