Immunoglobulin anti-Rhesus factor of Rho (D)

General characteristics. Structure:

Active ingredients - immunoglobulin – 300 mkg (an antiserum capacity 1:2000);

excipients - glycine (glycine, the aminoacetic acid), sodium chloride.

Main properties: drug is immunological active protein fraction of serum or a blood plasma of the immunizirovanny donors (or reimmunizirovanny donors) checked for lack of antibodies to VICh-1, VICh-2, to a virus of hepatitis C and a surface antigen of a virus of hepatitis B, the virus inactivation cleared and concentrated by a fractionation method alcohol, passed a stage solvent-detergentnym by method, with the high content of antibodies of anti-_{Rho (D)}. Protein content in 1.0 ml of drug from 0:09 g to 0:11 g. Transparent or with insignificant opalescence, colourless or yellowish liquid. At storage emergence of the insignificant deposit disappearing when stirring is possible. Drug does not contain preservative and antibiotics.

Pharmacological properties:

The operating basis of drug is immunoglobulin specific to _{Rho (D) antigen}. The antiserum capacity in 1 dose of drug makes not less than 1:2000 (300 mkg of immunoglobulin) that decides on the help of reaction of Koombs. Drug prevents a Rhesus factor sensitization of Rh-negative women, possible as a result of receipt _{of Rho (D)} - positive blood of a fruit in mother's blood stream at the birth _{of Rho (D)} - positive children, at abortion (both spontaneous, and artificial), in case of performing amniocentesis, at getting injured of an abdominal cavity during pregnancy.

Indications to use:

Drug is used:

- for performing prevention during the prenatal period at Rh-negative women, not sensibilized to _{Rho (D) antigen};

- for performing prevention in a puerperal period at Rh-negative women, not sensibilized to _{Rho (D) antigen}, i.e. not developed Rh antibodies (on condition of the first pregnancy and the birth of the Rh-positive child whose blood is compatible to mother's blood on AVO system blood groups);

- at abortion at Rh-negative women, also not sensibilized to _{Rho (D)} to antigen, in case of Rh-positive accessory of blood of the husband;

- at an abortion and threat of an abortion at any stage of pregnancy;

- when performing amniocentesis;

- at getting injured of abdominal organs during pregnancy.

Route of administration and doses:

At use it is necessary to consider the following criteria:

· Mother has to be a Rhesus factor - is negative and there should not be already a sensibilizirovan to _{Rho (D) antigen};

· Her child has to be Rh-positive and have a negative take of the direct antiglobulinovy test. If the drug is administered before childbirth, it is significantly important that mother received one more dose of drug after the birth of the Rh-positive child within 72 hours after the delivery. If it is established that the father Rh-negative to administer the drug there is no need.

Immunoglobulin is entered on one dose (300 mkg) intramusculary once:

- when performing prevention during the prenatal period approximately on the 28th week of pregnancy. After that it is necessary to enter one more dose (300 mkg), it is preferable within 72 hours after the delivery if the been born child is Rh-positive.

- when performing prevention in a puerperal period within the first 72 hours after the delivery;

- at artificial abortion, interruption of an extrauterine pregnancy – directly after the end of operation. At duration of gestation of more than 13 weeks introduction of one dose is recommended if pregnancy is interrupted on term less than 13 weeks, perhaps single use of a mini-dose of immunoglobulin (about 50 mkg);

- at an abortion and threat of an abortion – at any stage of pregnancy;

- when performing amniocentesis or at getting injured of abdominal organs during the second and/or third trimester of pregnancy – directly after the end of operation it is recommended to enter one dose of drug. If performing amniocentesis or an injury of abdominal organs demands administration of drug at the term of 13-18 weeks of pregnancy it is necessary to enter one more dose (300 mkg) on the term of 26-28 weeks.

One dose of drug (300 mkg) at AT 1:2000 caption.

Features of use:

It is forbidden to administer the drug intravenously!

Apply under observation of the doctor. Prior to introduction of an ampoule with drug maintain within 2 hours at the room temperature (20±2) ºС. In an open ampoule drug is not subject to storage. After the termination of a period of validity use of drug is inadmissible. Immunization of women live vaccines should be carried out not earlier than in 3 months after administration of immunoglobulin an anti-Rhesus factor _{of Rho (D)} of the person.

Use during pregnancy and feeding by a breast. See the sections "Indications to Use", "Route of Administration and Doses".

Children. It is forbidden to administer the drug the newborn! At the children who were born from the women receiving drug before childbirth at the birth receiving poorly positive takes of direct tests for availability of anti-globulin is possible. In blood serum of mother detection of the antibodies to _{Rho (D)} received in the passive way is possible if tests screenings for antibodies are carried out after prenatal or puerperal administration of immunoglobulin an anti-Rhesus factor _{of Rho (D)} of the person.

Side effects:

Reactions to administration of immunoglobulin, as a rule, are absent. In rare instances there can be local reactions in the form of a hyperemia and temperature increase to 37.5 ^{° C} within the first days after introduction. Drug with the changed reactivity can cause reactions of an allergy of different type in certain patients, and in rare instances - an acute anaphylaxis. In this regard the patients who received drug have to be under medical observation within 30 minutes. The dyspepsia phenomena are possible.

Interaction with other medicines:

The combination with other specific medicines is possible.

Contraindications:

Administration of immunoglobulin is contraindicated to the persons having heavy allergic reactions to introduction of proteinaceous blood preparations of the person in the anamnesis. Administration of drug to contraindicated Rh-positive women in childbirth, and also Rh-negative women in childbirth, sensibilized to _{Rho (D) antigen} in which serum Rh antibodies are found.

And in the next 3 days antihistaminic drugs are recommended to the patients having allergic diseases, or having them in the anamnesis in day of administration of immunoglobulin.

Overdose:

It was not studied.

Storage conditions:

In the dry, protected from light place at a temperature from 2 °C to 8 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

On 1 dose (300 mkg of immunoglobulin at an antiserum capacity 1:2000) in an ampoule. On 1 or 3, or 5 ampoules in a pack.