Gamma anti-hbs 200

Package Leaflet: Information for the Patient

GAMMA anti-HBs 200, 200 IU/ml

Solution for Injection

Human immunoglobulin against viral hepatitis B

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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, tell the doctor. See section 4.

Table of Contents of the Leaflet

• 1. What is GAMMA anti-HBs 200 and what is it used for
• 2. Important information before using GAMMA anti-HBs 200
• 3. How to use GAMMA anti-HBs 200
• 4. Possible side effects
• 5. How to store GAMMA anti-HBs 200
• 6. Contents of the pack and other information

1. What is GAMMA anti-HBs 200 and what is it used for

GAMMA anti-HBs is a solution for intramuscular injection containing 200 IU of anti-HBs antibodies in an aqueous solution.
The medicine is used prophylactically to protect the body against hepatitis B virus (HBV) infection. Administered intramuscularly, the immunoglobulins bind to the HBs antigen and prevent the occurrence of hepatitis B (HB). Passive immunity lasts for about 3 to 4 weeks.
The medicine is intended for:

• 1) newborns whose mothers are HBs antigen carriers,
• 2) children with a body weight of up to 50 kg, especially those at risk of hospital-acquired HBV infection.

2. Important information before using GAMMA anti-HBs 200

When not to use GAMMA anti-HBs 200:

• if the patient is allergic to human immunoglobulin or any other component of the medicine (listed in section 6).

Warnings and precautions

Before starting treatment with GAMMA anti-HBs 200, discuss it with your doctor.
GAMMA anti-HBs 200 must not be administered intravenously.
Ensure that the medicine is not administered directly into a blood vessel due to the risk of shock.
If the recipient is an HBsAg carrier, administration of this medicine does not provide any benefits.
Hypersensitivity
Specific hypersensitivity reactions are rare.
GAMMA anti-HBs 200 contains a small amount of IgA. Individuals with IgA deficiency may produce anti-IgA antibodies, which can cause anaphylactic reactions when components containing IgA are administered. Therefore, the doctor must weigh the benefits of treatment with GAMMA anti-HBs 200 against the potential risk of hypersensitivity reactions.
In rare cases, administration of hepatitis B immunoglobulin may cause a drop in blood pressure with an anaphylactic reaction, even in patients who have previously been well-tolerated to immunoglobulin.
If an allergic or anaphylactic reaction is suspected, administration of the medicine should be discontinued immediately. In case of shock, standard shock therapy procedures should be followed.
Effect on blood test results
After injection of immunoglobulin, there may be a temporary increase in the level of various passively transferred antibodies in the patient's blood, resulting in false-positive serological test results.
Passive transfer of antibodies against erythrocyte antigens, such as A, B, D, may interfere with the results of certain serological tests for the presence of red blood cell antibodies, such as the antiglobulin test (Coombs' test).
Infectious agents
Standard methods for preventing infections associated with the use of medicinal products derived from human blood or plasma include: donor selection, screening of individual donations and plasma pools for the presence of specific infection markers, and the inclusion of virus inactivation/removal steps in the manufacturing process. Despite this, for medicinal products derived from human blood or plasma, the risk of transmitting infectious agents cannot be completely excluded. This also applies to unknown or newly discovered viruses and other pathogens.
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 data indicate 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 medicine.
For the patient's benefit, it is recommended, if possible, to record the name and batch number of the GAMMA anti-HBs 200 medicine, along with the patient's data, after each use, to maintain a correlation between the batch number of the medicine and the patient.

GAMMA anti-HBs 200 and other medicines

Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The medicine may weaken the effectiveness of live attenuated virus vaccines, such as measles, mumps, and rubella. After administration of the immunoglobulin preparation, vaccination with these vaccines should be performed after 3 months.
If laboratory tests are performed, inform the doctor about the use of immunoglobulins, as this treatment may affect the results of serological tests.

Pregnancy, breastfeeding, and fertility

Pregnancy
The safety of using this medicinal product in pregnant women has not been evaluated in controlled clinical trials, and therefore caution should be exercised when used in pregnant or breastfeeding women. It has been shown that immunoglobulins cross the placenta, which increases in the third trimester. Clinical observations related to the administration of immunoglobulins indicate no harmful effect on the course of pregnancy, fetus, and newborn.
Breastfeeding
Immunoglobulins are excreted into breast milk and may contribute to the protection of the newborn against pathogens that penetrate mucous membranes.
Fertility
Clinical experience with the use of immunoglobulins indicates that no harmful effect on fertility is expected.

Driving and using machines

The medicine has no effect on the ability to drive and use machines.

3. How to use GAMMA anti-HBs 200

This medicine should always be used in accordance with the doctor's recommendations. 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. Do not use a solution that is cloudy or has sediment.
GAMMA anti-HBs 200 is administered intramuscularly:

• 1) to newborns whose mothers have had hepatitis B during pregnancy or are HBs antigen carriers, 200 IU is administered no later than 12 hours after birth,
• 2) to newborns who have not been vaccinated against hepatitis B; after 1 month from the first dose (200 IU), a second dose of 200 IU is administered,
• 3) to children with a body weight of up to 50 kg, according to the following scheme:
• newborns, infants, and children with a body weight of up to 10 kg are administered 200 IU (the contents of 1 ampoule),
• children with a body weight of 10 kg to 20 kg are administered 400 IU (the contents of 2 ampoules),
• children with a body weight of 20 kg to 30 kg are administered 600 IU (the contents of 3 ampoules),
• children with a body weight of 30 kg to 50 kg are administered 800 IU (the contents of 4 ampoules). In the case of prolonged hospitalization of the child, the dose is repeated every 3-4 weeks. In these situations, vaccination against hepatitis B is highly recommended. The first dose of the vaccine can be administered on the same day as the human immunoglobulin against hepatitis B, but in different locations.

If a dose greater than 400 IU (more than 2 ampoules) is used, it should be administered intramuscularly in different parts of the body, in divided doses.
If vaccination is necessary at the same time, the immunoglobulin and vaccine should be administered in two different parts of the body.
In patients who do not develop an immune response to the vaccine (no measurable hepatitis B antibodies) and in whom continuous disease prevention is necessary, administration of 500 IU in adults and 8 IU/kg in children every 2 months may be considered; the minimum protective antibody level is considered to be 10 IU/ml.
If there are contraindications to intramuscular administration (bleeding disorders), the medicine can be administered subcutaneously if no intravenous product is available. However, note that there are no clinical data available on the efficacy of subcutaneous administration of GAMMA anti-HBs 200.
Any unused medicine or waste material should be disposed of in accordance with local regulations.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported rarely (affecting 1 to 10 patients in 10,000 treated):
headache, low blood pressure, nausea, vomiting, skin reactions, rash, itching, joint pain, fever, malaise, chills; at the injection site: swelling, pain, redness, hardening, feeling of heat, itching, rash.
The following side effects have been reported very rarely (affecting less than 1 patient in 10,000 treated):
hypersensitivity, anaphylactic shock.
The frequency of the following side effects is unknown (cannot be estimated from the available data):
tachycardia.
Reporting of side effects
If any side effects occur, including any side effects not listed in the leaflet, tell the 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 of side effects will help to gather more information on the safety of the medicine.
Information on safety with respect to infectious agents, see section 2.

5. How to store GAMMA anti-HBs 200

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 month stated.
Store in a refrigerator (2°C - 8°C).
Protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Batch number (LOT)
Expiry date (EXP)

6. Contents of the pack and other information

What GAMMA anti-HBs 200 contains

• The active substance of the medicine is human immunoglobulin against viral hepatitis B. 1 ml of the solution contains at least 100 mg of human protein, including at least 85% immunoglobulin G (IgG) with an anti-HBs antibody content of 200 IU.
• The excipients are: glycine, sodium chloride, water for injections

What GAMMA anti-HBs 200 looks like and contents of the pack

GAMMA anti-HBs 200 is a clear or slightly opalescent solution.
The pack contains1 ampoule 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: