Gamma anti-d 150

GAMMA anti-D 150, 150 micrograms/ml

Solution for injection

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet

• 1. What is GAMMA anti-D 150 and what is it used for
• 2. Important information before using GAMMA anti-D 150
• 3. How to use GAMMA anti-D 150
• 4. Possible side effects
• 5. How to store GAMMA anti-D 150
• 6. Contents of the pack and other information

1. What is GAMMA anti-D 150 and what is it used for

GAMMA anti-D 150 is a solution of human immunoglobulin G containing 150 micrograms (750 IU) of anti-D antibodies.
The prevention of hemolytic disease of the newborn using GAMMA anti-D 150 involves inhibiting the immune response of a Rh-negative woman to the D antigen present in her fetus's red blood cells.
Administration of GAMMA anti-D 150 prevents the production of anti-D antibodies (anti-Rh) in the woman's body, in case about 7 ml of Rh-positive (positive) red blood cells enter her bloodstream.
The presence of anti-D antibodies in the case of an Rh-positive pregnancy can be a factor threatening the health of the child.
The medicine is administered within 72 hours after delivery and prevents the production of anti-D antibodies, thereby preventing the occurrence of hemolytic disease of the newborn in the next pregnancy.
When administered at 28 weeks of gestation, it prevents the formation of anti-D antibodies for 12 weeks before delivery. The medicine is also administered after the removal of the fetus after 12 weeks of gestation, in the event of a threatened premature birth, or after diagnostic amniocentesis after 12 weeks of gestation.
GAMMA anti-D 150 is ineffective if anti-D antibody production has already been stimulated in the mother's body, and therefore its administration to women who have produced anti-D antibodies is pointless.

2. Important information before using GAMMA anti-D 150

When not to use GAMMA anti-D 150:

Before administering the medicine, the following serological tests should be performed:

• determination of the woman's AB0 and Rh blood group, and after delivery also the newborn's,
• determination of the presence of anti-D antibodies in the woman's serum,
• performance of a direct antiglobulin test on the child's red blood cells after delivery. The doctor should ask, and the woman should provide full information about:
• any history of allergic reactions to human immunoglobulin and any other substances, such as foods, preservatives, and others,
• any history of serious diseases, especially immune system disorders.
• The medicine must not be administered intravenously.
• The medicine must not be administered to newborns.
• The medicine must not be administered to Rh-positive (D+) women.
• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with GAMMA anti-D 150, the patient should discuss it with their doctor.
Hypersensitivity
True hypersensitivity reactions are rare, but allergic reactions to the administration of anti-D immunoglobulin may occur.
The patient should be monitored for at least 20 minutes after administration.
GAMMA anti-D 150 contains small amounts of IgA. Although anti-D immunoglobulin is used in patients with IgA deficiency with positive results, there is a potential risk of antibody production against IgA, and anaphylactic reactions may occur after administration of products containing IgA. Therefore, the doctor must weigh the benefits of GAMMA anti-D 150 therapy against the potential risk of hypersensitivity reactions.
Rarely, human anti-D immunoglobulin may cause a drop in blood pressure with anaphylactic reaction, even in patients who have previously tolerated this immunoglobulin well. Patients should be informed about the early symptoms of hypersensitivity reactions, including rash, generalized urticaria, chest tightness, low blood pressure, wheezing, and anaphylaxis. Treatment depends on the cause and severity of the adverse reaction.
If symptoms of an allergic or anaphylactic reaction occur, the product should be discontinued immediately and appropriate medical treatment should be initiated.
Hemolytic reactions
Patients who have received incompatible blood transfusions and are receiving very high doses of anti-D immunoglobulin should be monitored in a clinical setting and tested for biological parameters.
GAMMA anti-D 150 is produced from human plasma of individuals with high titers of anti-D antibodies.
Standard measures to prevent infections resulting from the use of medicinal products produced from human blood or plasma include: donor selection, screening of individual donations and plasma pools for specific infection markers, and inclusion of virus inactivation/removal steps in the manufacturing process. Despite this, the risk of transmitting infectious agents cannot be completely excluded when administering medicines obtained from human blood or plasma. This also applies to pathogens and viruses that are currently unknown or newly discovered.
Measures considered effective against enveloped viruses such as HIV, HBV, and HCV may have limited significance with regard to non-enveloped viruses such as HAV and/or parvovirus B19.
There is clinical experience indicating that hepatitis A virus and parvovirus B19 are not transmitted during the use of immunoglobulins. It is also assumed that the presence of antibodies plays an important role in the virological safety of the product.
In the interest of the patient, it is recommended, if possible, to record the name and batch number of the GAMMA anti-D 150 product, along with the patient's data, after each use, to maintain a correlation between the batch number of the product and the patient.

GAMMA anti-D 150 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The medicine may reduce the effectiveness of live attenuated virus vaccines, such as measles, rubella, and mumps. After administration of the immunoglobulin preparation, vaccination with these vaccines should be performed after 3 months.
In the case of laboratory tests, the patient should inform their doctor about the use of immunoglobulins, as this treatment may affect the results of serological tests.

Pregnancy and breastfeeding

The medicine is used during pregnancy and breastfeeding.

Fertility

If the patient plans to have a child, they should consult their doctor before using this medicine. No clinical trials on fertility have been conducted with GAMMA anti-D 150 in animals. However, clinical experience with the use of human anti-D immunoglobulin does not indicate any harmful effects on fertility.

Driving and using machines

GAMMA anti-D 150 does not affect the ability to drive and use machines.

3. How to use GAMMA anti-D 150

This medicine should always be used exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor.
GAMMA anti-D 150 is administered intramuscularly.
The medicine must not be administered intravenously.
Recommended dosage:
The medicine is administered intramuscularly within 48 hours, and no later than 72 hours, in the following situations:

• 1 dose (150 micrograms) is administered after a physiological delivery, after the removal of the fetus after 12 weeks of gestation, in the event of a threatened premature birth, or after diagnostic amniocentesis after 12 weeks of gestation,
• 2 doses (300 micrograms) are administered after a pathological delivery, e.g., cesarean section, manual separation of the placenta, after the birth of a stillborn child,
• 2-3 doses (300-450 micrograms) are administered after fetal bleeding into the maternal bloodstream (it is recommended to determine the size of the fetomaternal hemorrhage and select the appropriate dose),
• after a multiple birth, the number of doses administered is equal to the number of children.

The medicine is administered during pregnancy:

• 2 doses (300 micrograms) are administered simultaneously to Rh-negative women at 28 weeks of gestation, in whom no anti-D antibodies are detected.

The medicine should be administered intramuscularly by a doctor or nurse. Before use, the medicine should be brought to room temperature or body temperature. The doctor or nurse should check if the solution in the ampoule is clear or slightly opalescent.
The medicine should not be used if the solution is cloudy or contains sediment. Any unused medicine or waste should be disposed of in accordance with local regulations.
In the event of coagulation disorders, when intramuscular administration is contraindicated, GAMMA anti-D 150 can be administered subcutaneously. The injection site should be secured by manual compression with a compress.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may occur even if the patient has previously taken immunoglobulins and tolerated them well.
Occasionally, side effects such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, joint pain, low blood pressure, and moderate lower back pain may occur. Rarely, human immunoglobulins may cause a sudden drop in blood pressure and anaphylactic shock, even in patients who have not shown hypersensitivity reactions after previous administration of the product.
Local reactions at the injection site: swelling, pain, redness, induration, warmth, itching, bruising, rash.
The following side effects have occurred rarely (affecting 1 to 10 patients per 10,000 treated):
headache, skin reactions, fever, malaise, chills.
The following side effects have occurred very rarely (affecting less than 1 patient per 10,000 treated):
allergic reactions and anaphylactic reactions (dyspnea and shock symptoms), tachycardia, low blood pressure, nausea, vomiting.
The frequency of the following side effects is unknown (cannot be estimated from the available data):
redness, itching, joint pain, at the injection site: swelling, pain, tenderness, redness, induration, warmth, itching, rash.
In the event of symptoms of anaphylactic shock (pain and dizziness, lip and tongue swelling, pallor, urticaria, low blood pressure, cardiac arrhythmias, dyspnea, vomiting, diarrhea, seizures, loss of consciousness), the patient should immediately contact their doctor to receive immediate medical attention.
Information on safety with regard to infectious agents, see section 2.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz2.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store GAMMA anti-D 150

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Store in a refrigerator (2°C - 8°C).
Protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Batch number (LOT)
Expiry date (EXP)

6. Contents of the pack and other information

What GAMMA anti-D 150 contains

• The active substance is human anti-D immunoglobulin, 150 micrograms (750 IU)/ml
• The excipients are glycine, sodium chloride, water for injections

What GAMMA anti-D 150 looks like and what the pack contains

The medicine is a clear or slightly opalescent solution for injection.
The pack contains1 ampoule of 1 ml

Marketing authorization holder and manufacturer

Synthaverse S.A.
Uniwersytecka Street 10, 20-029 Lublin
phone 81 533 82 21
fax 81 533 80 60
e-mail [email protected]

Date of last revision of the leaflet: