Package leaflet: Information for the user

GAMMA anti-D 50, 50 micrograms/ml
Solution for injection
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor. See section 4.

Contents of the leaflet

What GAMMA anti-D 50 is and what it is used for
Important information before using GAMMA anti-D 50
How to use GAMMA anti-D 50
Possible side effects
How to store GAMMA anti-D 50
Contents of the pack and other information

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

GAMMA anti-D 50 is a solution of human immunoglobulin G containing 50 micrograms (250 IU) of anti-D antibodies.
Administration prevents the formation of anti-D (anti-Rh) antibodies in the body of a woman when approximately 2.5 ml of Rh-positive red blood cells have entered her circulation.
The presence of anti-D antibodies during pregnancy with an Rh-positive fetus may pose a risk to the child's health.
This medicine is administered after spontaneous abortion, termination of pregnancy, or removal of an ectopic pregnancy, in cases where the woman is Rh-negative and does not have anti-D antibodies in serum.
For administration after delivery, during pregnancy, and after fetal loss after 12 weeks of gestation, as well as in cases of threatened preterm delivery or after diagnostic amniocentesis beyond 12 weeks of gestation, the product GAMMA anti-D 150 is indicated.

2. Important information before using the medicine 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 AB0 and Rh group in the woman,
determination of the presence of anti-D antibodies in the woman's serum.

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

any previous allergic reactions to human immunoglobulin and to any other substances such as foods, preservatives, and others,
any serious previous illnesses, especially disorders of the immune system.
The medicine must not be administered intravenously.
It must not be given to newborns.
It must not be given to Rh-positive (D+) women.
If the patient is allergic to the active substance or to any of the other components of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with GAMMA anti-D 50, discuss this with your doctor.
Hypersensitivity
True hypersensitivity reactions are rare, but allergic-type reactions to anti-D immunoglobulin administration may occur.
The patient should be observed for at least 20 minutes after administration.
GAMMA anti-D 50 contains small amounts of IgA. Although anti-D immunoglobulin has been used successfully in patients with IgA deficiency, in such individuals there is a potential risk of developing anti-IgA antibodies, and anaphylactic reactions may occur after administration of medicinal products containing IgA. Therefore, the physician must weigh the benefits of therapy with GAMMA anti-D 50 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 previously tolerated the immunoglobulin well. Patients should be informed about early signs of hypersensitivity reactions, including: rash, generalized urticaria, chest tightness, hypotension, 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 must be stopped immediately and appropriate medical measures should be taken.

Hemolytic reactions
Patients who have received ABO-incompatible blood transfusions and who are receiving very high doses of anti-D immunoglobulin should be monitored in a clinical setting and tested for relevant biological parameters.
GAMMA anti-D 50 is manufactured from human plasma of donors with high titers of anti-D antibodies.
Standard measures to prevent infections from medicinal products derived from human blood or plasma include: donor selection, screening of individual donations and plasma pools for specific infection markers, and inclusion of effective viral inactivation/removal steps in the manufacturing process. Nevertheless, when administering medicines derived from human blood or plasma, the risk of transmitting infectious agents cannot be completely ruled out. This also applies to pathogens and viruses not yet known or newly discovered.
Measures taken are considered effective against enveloped viruses such as HIV, HBV, and HCV. However, they may have limited effectiveness against non-enveloped viruses such as HAV and/or parvovirus B19.
There is clinical experience showing no transmission of hepatitis A virus and parvovirus B19 during immunoglobulin administration. It is also believed that the presence of antibodies plays an important role in the virological safety of the product.
For the patient's safety, it is recommended, whenever possible, to record the name and batch number of the product GAMMA anti-D 50 together with the patient's data each time the product is administered, in order to maintain traceability between the product batch number and the patient.

GAMMA anti-D 50 and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take. The medicine may reduce the effectiveness of vaccines containing live attenuated viruses, such as measles, mumps, and rubella. Vaccination with these vaccines should be performed at least 3 months after administration of immunoglobulin preparation.
When undergoing laboratory tests, inform the 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 while breastfeeding.

Effect on fertility
If the patient plans to have a child, she should consult her doctor before using this medicine. No clinical studies on animal fertility have been conducted with the product GAMMA anti-D 50. However, clinical experience with the use of human anti-D immunoglobulin does not indicate harmful effects on fertility.

Driving and operating machinery
The medicine GAMMA anti-D 50 has no effect on the ability to drive or operate machinery.

3. How to use GAMMA anti-D 50
This medicine should always be used according to the doctor's instructions. In case of doubt, consult your doctor.
GAMMA anti-D 50 is administered intramuscularly.
It must not be administered intravenously.
One vial of the medicine should be administered intramuscularly within 12 weeks of pregnancy, within 48 hours, and no later than 72 hours:

after spontaneous abortion,
after termination of pregnancy,
after removal of ectopic (extrauterine) pregnancy.

The medicine should be administered intramuscularly by a doctor or nurse. The medicine should be brought to room temperature or body temperature before use. The doctor or nurse should check whether the solution in the vial is clear or slightly opalescent. The solution must not be used if it is cloudy or contains a precipitate. Any unused portions of the medicine or waste materials should be disposed of according to local regulations. In cases of coagulation disorders when intramuscular administration is contraindicated, GAMMA anti-D 50 may be administered subcutaneously. The injection site should be protected by manual compression with a compress.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
Adverse reactions may occur even if the patient has previously received immunoglobulins and tolerated them well.
Occasionally, adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, joint pain, low blood pressure, and moderate lumbosacral pain may occur. Rarely, human immunoglobulins may cause a sudden drop in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has not shown hypersensitivity reactions after previous administration of the product.

Local reactions at the injection site: swelling, pain, erythema, induration, warmth, itching, bruising, rash.

The following adverse reactions have been reported rarely (affects 1 to 10 patients per 10,000 treated):
headache, skin reactions, fever, malaise, chills.

The following adverse reactions have been reported very rarely (affects less than 1 patient per 10,000 treated):
allergic reactions and anaphylactic reactions (dyspnea and shock symptoms), tachycardia, hypotension, nausea, vomiting.

The frequency of occurrence of the following adverse reactions is unknown (cannot be estimated from the available data):
erythema, itching, joint pain, at the administration site: swelling, pain, tenderness to pressure, erythema, induration, sensation of warmth, itching, rash.

If any symptoms of anaphylactic shock occur (pain and dizziness, swelling of lips and tongue, pallor, urticaria, hypotension, cardiac arrhythmia, dyspnea, vomiting, diarrhea, convulsions, loss of consciousness), contact a doctor immediately to receive urgent medical assistance.

For information regarding safety with respect to infectious agents, see section 2.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website:
https://smz2.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store GAMMA anty-D 50

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Store in a refrigerator (2ºC - 8ºC).
Protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Batch number (LOT)
Expiry date (EXP)

6. Contents of the package and other information

What GAMMA anty-D 50 contains

The active substance is human anti-D immunoglobulin, 50 micrograms (250 I.U.)/ml
The other components are: glycine, sodium chloride, water for injections

What GAMMA anty-D 50 looks like and contents of the pack
The medicine is a clear or slightly opalescent solution for injection.
Pack contents: 1 vial containing 1 ml
Marketing Authorisation 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]