Gamma anti-d 150

GAMMA anty-D 150, 150 micrograms/ml
Injection solution
Please read the package leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor. See section 4.

Table of contents

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

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

GAMMA anty-D 150 is a solution of human immunoglobulin G containing 150 micrograms (750 IU) of anti-D (anti-Rh) antibodies.
Prophylaxis of hemolytic disease of the newborn with GAMMA anty-D 150 works by suppressing the immunological response of an Rh-negative woman to the D antigen present in her fetus's red blood cells.
Administration of GAMMA anty-D 150 prevents the formation of anti-D (anti-Rh) antibodies in the woman's body when approximately 7 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 health of the child.
The medicine should be administered within 72 hours after delivery and prevents the production of anti-D antibodies, thereby preventing hemolytic disease of the newborn in subsequent pregnancies.
When administered at 28 weeks of gestation, it protects against the formation of anti-D antibodies during the 12 weeks preceding delivery. GAMMA anty-D 150 is also administered after fetal loss after 12 weeks of gestation, threatened or preterm labor, or diagnostic amniocentesis performed after 12 weeks of gestation.
GAMMA anty-D 150 is ineffective if the mother's immune system has already been stimulated to produce antibodies. Therefore, administration to women who have already developed anti-D antibodies is not indicated.

2. Important information before using the medicine GAMMA anty-D 150

When not to use GAMMA anty-D 150:
Before administering the medicine, the following serological tests should be performed:

• determination of AB0 and Rh group in the woman, and after delivery also in the newborn,
• 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 regarding:
• any previous allergic reactions to human immunoglobulin and to any other substances such as food, 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 anty-D 150, discuss this with your doctor.
Hypersensitivity
True hypersensitivity reactions are rare, but allergic-type responses may occur following administration of anti-D immunoglobulin.
The patient should be observed for at least 20 minutes after administration.
GAMMA anty-D 150 contains small amounts of IgA. Although anti-D immunoglobulin has been used successfully in patients with IgA deficiency, there is a potential risk of developing anti-IgA antibodies in such individuals, and anaphylactic reactions may occur after administration of medicinal products containing IgA. Therefore, the physician must weigh the benefits of therapy with GAMMA anty-D 150 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 administration of this 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 treatment initiated.
Hemolytic reactions
Patients who have received a blood transfusion with incompatible blood groups 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 anty-D 150 is manufactured from human plasma of individuals 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 transmission of infectious agents cannot be completely excluded, including 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.
Clinical experience indicates no transmission of hepatitis A virus or 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 anty-D 150 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 anty-D 150 and other medicines
You should inform your doctor about all medicines currently taken 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 the immunoglobulin preparation.
If laboratory tests are being performed, the doctor should be informed about immunoglobulin administration, 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 fertility in animals have been conducted with GAMMA anty-D 150. However, clinical experience with the use of human anti-D immunoglobulin does not indicate harmful effects on fertility.

Driving and operating machinery
GAMMA anty-D 150 has no effect on the ability to drive or operate machinery.

3. How to use GAMMA anty-D 150

This medicine should always be used as directed by a physician. In case of doubt, consult a physician.

GAMMA anty-D 150 is administered intramuscularly.
Intravenous administration is not permitted.

Recommended dosage:
The medicine should be administered intramuscularly within 48 hours, and no later than 72 hours, in the following situations:

• 1 dose (150 micrograms) after normal delivery, after removal of a fetus beyond 12 weeks of gestation, in threatened premature labor, or after diagnostic amniocentesis beyond 12 weeks of gestation;
• 2 doses (300 micrograms) after complicated delivery, e.g., cesarean section, manual removal of the placenta, or after delivery of a stillborn fetus;
• 2–3 doses (300–450 micrograms) after fetal-maternal hemorrhage (determination of the volume of transplacental hemorrhage is recommended to adjust the appropriate dose);
• after multiple births, administer as many doses as the number of infants.

The medicine is administered during pregnancy:

• 2 doses (300 micrograms) at once to Rh-negative women at 28 weeks of gestation who have no detectable anti-D antibodies.

The medicine should be administered intramuscularly by a physician or nurse. Prior to administration, the medicine should be brought to room temperature or body temperature. The physician or nurse should check whether the solution in the ampoule is clear or slightly opalescent.
Do not use the solution if it is cloudy or contains a precipitate. Any unused medicine or waste material should be disposed of according to local regulations.

In cases of coagulation disorders when intramuscular administration is contraindicated, GAMMA anty-D 150 may be administered subcutaneously. After injection, apply manual pressure with a compress to secure the injection site.

4. Possible adverse reactions

Like any medicine, this medicinal product may cause adverse reactions, although not everyone 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 individual 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 occurred rarely (affects 1 to 10 patients per 10,000 treated):
headache, skin reactions, fever, malaise, chills.

The following adverse reactions have occurred 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.

In the event of any symptoms of anaphylactic shock (pain and dizziness, swelling of lips and tongue, pallor, urticaria, hypotension, cardiac arrhythmia, dyspnea, vomiting, diarrhea, seizures, loss of consciousness), immediate contact with a physician is required to obtain emergency 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 for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 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.
Reporting adverse reactions contributes to enhancing the safety information regarding the use of this medicinal product.

5. How to store GAMMA anty-D 150

Keep this medicine out of 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 packaging and other information

What GAMMA anty-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 anty-D 150 looks like and contents of the pack
GAMMA anty-D 150 is a clear or slightly opalescent solution for injection.
Pack contents: 1 vial containing 1 ml
Marketing Authorisation Holder and Manufacturer
Synthaverse S.A.
Uniwersytecka 10, 20-029 Lublin
tel 81 533 82 21
fax 81 533 80 60
e-mail [email protected]
Date of the latest revision of the leaflet: