Gamma anti-d 50

Leaflet attached to the packaging: patient information

GAMMA anti-D 50, 50 micrograms/ml

Solution for injection

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

important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please 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 inform their doctor. See section 4.

Table of contents of the leaflet

• 1. What is GAMMA anti-D 50 and what is it used for
• 2. Important information before using GAMMA anti-D 50
• 3. How to use GAMMA anti-D 50
• 4. Possible side effects
• 5. How to store GAMMA anti-D 50
• 6. Contents of the packaging and other information

1. What is GAMMA anti-D 50 and what is it used for

GAMMA anti-D 50 is a solution of human immunoglobulin G containing 50 micrograms (250 IU) of anti-D antibodies.
The administration protects against the formation of anti-D antibodies (anti-Rh) in the woman's body, in case
about 2.5 ml of Rh+ (positive) red blood cells enter the woman's bloodstream.
The presence of anti-D antibodies in the case of Rh+ pregnancy may pose a risk to the child's health.
The medicine is administered after a spontaneous abortion, after termination of pregnancy, or after removal of an ectopic pregnancy
if the woman is Rh- (negative) and has no anti-D antibodies in her serum.
For administration after childbirth, during pregnancy, and after removal of the fetus after 12 weeks of pregnancy,
in the case of threatened premature birth or preterm birth, after diagnostic amniocentesis after 12 weeks of pregnancy, GAMMA anti-D 150 is used.

2. Important information before using GAMMA anti-D 50

When not to use GAMMA anti-D 50:

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

• determination of the woman's AB0 and Rh blood group,
• determination of the presence of anti-D antibodies in the woman's serum.

The doctor should ask, and the woman should provide full information about:

• any allergic reactions to human immunoglobulin and any other substances, such as foods, preservatives, and others,
• any serious diseases she has had, 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) women (D+).
• 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 50, 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 observed for at least 20 minutes after administration.
GAMMA anti-D 50 contains small amounts of IgA. Although human anti-D immunoglobulin is used in patients with IgA deficiency with a positive effect, there is a potential risk of developing anti-IgA antibodies in such patients, and anaphylactic reactions may occur after administration of products containing IgA. Therefore, the doctor must weigh the benefits of GAMMA anti-D 50 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, administration of the product should be stopped immediately and appropriate medical treatment should be applied.
Hemolytic reactions
Patients who have received incompatible blood transfusions and are receiving very high doses of anti-D immunoglobulin should be monitored clinically and tested for biological parameters.
GAMMA anti-D 50 is produced from human plasma 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 drugs 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 there is no transmission of hepatitis A virus and parvovirus B19 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 50 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 50 and other medicines

The patient should inform 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. Vaccination with these vaccines should be performed 3 months after administration of the immunoglobulin preparation.
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, she should consult her doctor before using this medicine. No clinical fertility studies have been conducted with GAMMA anti-D 50 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 50 does not affect the ability to drive and use machines.

3. How to use GAMMA anti-D 50

This medicine should always be used according to the doctor's recommendations. In case of doubts, the patient should consult their doctor.
GAMMA anti-D 50 is administered intramuscularly.
It must not be administered intravenously.
1 vial of the medicine is administered intramuscularly up to 12 weeks of pregnancy, within 48 hours, and no later than 72 hours:

• after a spontaneous abortion,
• after termination of pregnancy,
• after removal of an ectopic pregnancy (outside the uterus). 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 vial is clear or slightly opalescent. The solution should not be used if it is cloudy or has sediment. Any unused medicine or waste should be disposed of in accordance with local regulations. If there are coagulation disorders and intramuscular administration is contraindicated, GAMMA anti-D 50 can be administered subcutaneously. The injection site should be compressed manually.

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, in individual cases, anaphylactic shock, even if the patient has not shown any hypersensitivity reaction 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 in 10,000 treated):
headache, skin reactions, fever, malaise, chills.
The following side effects have occurred very rarely (affecting less than 1 patient in 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 case of symptoms of anaphylactic shock (pain and dizziness, swelling of the lips and tongue, paleness, urticaria, low blood pressure, arrhythmia, 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 inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 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 50

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 stated 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 packaging and other information

What GAMMA anti-D 50 contains

• The active substance is human anti-D immunoglobulin, 50 micrograms (250 IU)/ml
• The excipients are: glycine, sodium chloride, water for injections

What GAMMA anti-D 50 looks like and what the packaging contains

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

Marketing authorization holder and manufacturer

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

Date of last revision of the leaflet: