KamROU - Instructions For The Use Of Immunoglobulin, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

CAMROW

KamROU: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: KamRho

ATX code: J06BB01

Active ingredient: human immunoglobulin antirhesus Rho (D) [Immune globulin human antirhesus Rho (D)]

Manufacturer: Kamada Ltd. (Kamada Ltd.) (Israel)

Description and photo update: 2019-09-07

Prices in pharmacies: from 5353 rubles.

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CamROU is an immunoglobulin.

Release form and composition

The drug is available in the form of a solution for intramuscular injection: colorless or light yellow, transparent or opalescent, may contain a certain amount of suspended protein particles (2 ml each in colorless glass vials, in a cardboard box 1 bottle and a needle with a filter, as well as instructions for application of CamROU).

Composition of 1 ml solution:

• active ingredient: human immunoglobulin antiresus Rho (D) - 150 mcg [750 International units (IU)];
• auxiliary substances: water for injection, glycine.

Pharmacological properties

Pharmacodynamics

Human anti-rhesus immunoglobulin Rho (D), contained in KamROU as an active ingredient, is an immunologically active protein fraction that is isolated from human serum or plasma of donors and is tested for the absence of antibodies to the hepatitis B surface antigen virus (HBsAg), hepatitis C (anti-HCV) and human immunodeficiency (HIV).

The active component of the drug is immunoglobulin G, which contains incomplete anti-Rho (D) antibodies. It is intended to prevent isoimmunization of a Rh-negative mother who has been exposed to Rh-positive fetal blood in the following cases: the birth of a Rh-positive child, abortion (spontaneous or artificial), amniocentesis, and trauma to the abdominal organs during pregnancy.

CamROU reduces the incidence of isoserological incompatibility of a Rh-negative mother if it is introduced during the first 48–72 hours into the field of birth of a full-term Rh-positive baby.

Pharmacokinetics

After intramuscular administration of the drug, antibodies reach their maximum concentration in the blood within 24 hours.

The half-life (T _½) of the drug from the body is 4–5 weeks.

Indications for use

CamROU is intended to prevent the development of Rh-conflict in Rh-negative women who are not sensitized to the Rho (D) antigen (i.e., in the absence of Rh antibodies), in the following cases:

• first pregnancy and birth of a Rh-positive child;
• the risk of spontaneous abortion;
• Rh-positive blood belonging to the husband;
• spontaneous or induced abortion;
• termination of an ectopic pregnancy;
• carrying out amniocentesis or other procedures associated with the risk of fetal blood entering the mother's bloodstream;
• getting an abdominal injury.

CamROU is also used in Rh-negative patients for transfusion of Rh-positive blood or preparations containing red blood cells.

Contraindications

Immunoglobulin KamROU is contraindicated in the following categories of patients:

• Rh-negative women in labor, sensitized to the Rho (D) antigen, whose serum contains Rh antibodies;
• Rh-positive patients;
• newborn children.

In addition, the drug is contraindicated in the presence of hypersensitivity to its components.

KamROU, instructions for use: method and dosage

KamROU solution is administered only intramuscularly. Preliminarily, for 2 hours, the vials with the drug are kept at room temperature (18–22 ° С). The solution should be drawn into the syringe using a needle with a wide lumen, otherwise foam may form. Opened vials cannot be stored.

The drug is prescribed for 1 dose of 300 μg (1500 IU) at a titer of 1: 2000 or 1 dose of 600 μg (3000 IU) at a titer of 1: 1000. In some cases, 2 doses of 600 mcg are required.

CamROU can only be administered if the woman is Rh negative and has not been sensitized to Rho (D), and her child is Rh positive.

If the drug is administered before delivery, it is imperative that the mother receives another dose within 48–72 hours after the birth of the Rh-positive baby. If it is confirmed that the father of the newborn is Rh negative, there is no need to inject CamROU.

Within 30 minutes after the administration of the drug, the patient should be under medical supervision.

Dosing modes of KAMROU:

• prevention in the prenatal period: 1 dose of 300 mcg is administered at about the 28th week of pregnancy. Then, if the born child turns out to be Rh-positive, within 48–72 hours after childbirth, another dose of 300 μg is administered;
• prophylaxis in the postpartum period: 1 dose of 300 mcg is administered, preferably in the first 48–72 hours after childbirth. In the case of the passage of the full term of pregnancy, the need for a particular dose may vary depending on how much fetal blood has entered the mother's bloodstream. 1 dose of 300 mcg contains a sufficient amount of antibodies to prevent sensitization to the Rh factor, if the volume of fetal red blood cells entering the mother's bloodstream is up to 15 ml. If there is reason to suspect that a larger volume of red blood cells has entered (> 15 ml of red blood cells or> 30 ml of whole blood), then fetal red blood cells are counted using any approved laboratory technique (for example, using a modified acid wash-staining method according to Kleihauer and Betke), and then establish the required dosage of immunoglobulin. For this, the calculated volume of fetal erythrocytes that have entered the mother's bloodstream is divided by 15 ml and thus the required number of doses of KamROU is obtained. If, according to calculations, a fractional number is obtained, the figure is rounded up to an integer (for example, when receiving 1.5, 2 doses of the drug are injected - 600 μg);
• threat of termination of pregnancy at any time: 1 dose of 300 mcg is administered. If it is assumed that more than 15 ml of fetal red blood cells have entered the woman's bloodstream, the recommendations above should be followed;
• termination of an ectopic pregnancy, artificial / spontaneous abortion for a period of less than 13 weeks: immediately after the operation, 1 dose of 300 μg is administered. If more than 15 ml of fetal red blood cells have entered the woman's bloodstream, the recommendations above should be followed. If the pregnancy is terminated less than 13 weeks, a mini dose of about 50 mcg (250 IU) may be sufficient;
• carrying out amniocentesis at 15-18 weeks of pregnancy or in the third trimester, trauma to the abdominal organs in the second-third trimesters: 1 dose of 300 mcg is administered. If it is suspected that more than 15 ml of fetal red blood cells have entered the woman's bloodstream, the recommendations indicated above should be followed. If amniocentesis, trauma to the abdominal organs or other unfavorable circumstance occurs at 13-18 weeks of pregnancy, then at 26-28 weeks, another 1 dose of 300 mcg is administered. To ensure protection during the entire gestation period, the concentration of passively obtained antibodies to Rho (D) must not be allowed to fall below the level necessary to prevent an immune response to Rh-positive fetal erythrocytes. If an Rh-positive baby is born, 1 dose of 300 mcg should be given within 48–72 hours. If delivery occurs within 3 weeks after the last dose of CamROU, the use of the postpartum dose is optional, unless more than 15 ml of fetal red blood cells have entered the mother's bloodstream.

Side effects

• from the digestive system: dyspeptic disorders;
• on the part of the skin: swelling, hyperemia and discomfort at the injection site;
• from the immune system: rarely - allergic reactions of varying severity, up to anaphylactic shock;
• others: an increase in body temperature up to 37.5 ° C (during the first days after injection).

Overdose

There are no data on cases of overdose.

special instructions

The injections of the drug should be carried out by medical personnel in rooms equipped with the necessary means and equipment for anti-shock therapy.

If it is determined that the father is Rho (D) -negative, there is no need to enter CamROU.

In children born to women who received human immunoglobulin anti-rhesus Rho (D) before delivery, it is possible to obtain weakly positive results of direct tests for the presence of antiglobulin at birth.

If screening tests for antibodies are performed in the mother after prenatal or postnatal administration of human anti-Rho (D) immunoglobulin, anti-Rho (D) antibodies may be detected in the serum.

Do not use the drug in case of improper storage, expired shelf life, changes in the physical properties of the solution (discoloration, turbidity, the appearance of unbreakable flakes), labeling violations or the integrity of the vials.

Influence on the ability to drive vehicles and complex mechanisms

No information available.

Application during pregnancy and lactation

Immunoglobulin KamROU is used during pregnancy and lactation according to indications.

Pediatric use

The drug is contraindicated in newborn children.

With impaired renal function

There is no information about the need to adjust the dose of KAMROU in case of impaired renal function.

For violations of liver function

There is no information on the need to adjust the dose of KamROU in case of impaired liver function.

Drug interactions

CamROU can be used concurrently with other medicines, including antibiotics.

If it is necessary to carry out immunization with live vaccines, the vaccination should be done at least 3 months after the introduction of KamROU.

Analogs

CamROU analogs are: Rezogam N, HyperROU S / D, Partobulin SDF, Human immunoglobulin antiresus Rho (D), Immunoro Kedrion, Resonative.

Terms and conditions of storage

Store in its original packaging in a dark place out of the reach of children, at a temperature of 2 to 8 ° C. Avoid freezing.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Camrou

Reviews about KamROU are positive: the drug helps to avoid Rh-conflict in Rh-negative pregnant women, is well tolerated without causing side effects.

Of the negative points, only the inconvenience of storage (in the refrigerator) and the high cost are indicated, however, most receive the drug for free in the antenatal clinic, therefore, they do not consider this a disadvantage.

Price for KamROU in pharmacies

Depending on the region of sale and the pharmacy network, the price of KamROU for 1 bottle of 2 ml 750 IU / ml can be 5780–7446 rubles.

KamROU: prices in online pharmacies

Drug name Price Pharmacy

KAMROU 750 IU / ml solution for intramuscular injection 2 ml 1 pc. 5353 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!