SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
GAMMA anty-HBs 200, 200 IU/ml
solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Human hepatitis B immunoglobulin
1 ml of the solution contains human protein not less than 100 mg, of which at least 85% is immunoglobulin G (IgG) with anti-HBs antibody content 200 IU
The product is manufactured from human donor serum.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection
Clear or slightly opalescent solution.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Immunoprophylaxis of hepatitis B.
in neonates of mothers who are hepatitis B virus carriers.
in children with body mass of up to 50 kg especially exposed to HBV infection at the hospital.
4.2 Posology and method of administration
GAMMA anty-HBs 200 is administered to: neonates whose mothers had hepatitis B infection during pregnancy or are HBs antigen carriers are administered 200 IU no later than up to 12 hours after birth,
neonates who were not vaccinated against hepatitis B; 1 month since the first dose (200 IU) the second dose of 200 IU is administered,
3) children with body mass of up to 50 kg are administered the product according to the following regimen:
neonates, infants and children with body mass of up to 10 kg are administered 200 IU (contents of 1 ampoule),
children with body mass of 10 kg to 20 kg are administered 400 IU (contents of 2 ampoules),
children with body mass of 20 kg to 30 kg are administered 600 IU (contents of 3 ampoules),
children with body mass of 30 kg to 50 kg are administered 800 IU (contents of 4 ampoules).
In case of child’s long-term stay at the hospital the dose is repeated every 3-4 weeks.
In all these situations, vaccination against hepatitis B virus is highly recommended. The first vaccine dose can be injected the same day as human hepatitis B immunoglobulin, however in different sites.
In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination, and for whom continuous prevention is necessary, administration of 500 IU to adults and 8 IU/kg to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 IU/mL.
Method of administration
GAMMA anty-HBs 200 should be administered via the intramuscular route.
If dose higher than 400 IU (contents of more than 2 ampoules) is used, the product should be administered intramuscularly in different parts of the body in divided doses.
When simultaneous vaccination is necessary, the immunoglobulin and the vaccine should be administered at two different sites.
If intramuscular administration is contraindicated (bleeding disorders), the injection can be administered subcutaneously if no intravenous product is available. However, it should be noted there are no clinical data regarding efficacy of the subcutaneous administration of GAMMA anty-HBs 200.
Hypersensitivity to active substance human immunoglobulin or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
GAMMA anty-HBs cannot be administered intravenously.
Ensure that GAMMA anty-HBs 200 is not administered into a blood vessel, because of the risk of shock.
If the recipient is a carrier of HBsAg, there is no benefit in administering this product.
True hypersensitivity reactions are rare.
GAMMA anty-HBs 200 contains a small quantity of IgA. Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA. The physician must therefore weigh the benefit of treatment with GAMMA anty-HBs 200 against the potential risk of hypersensitivity reactions.
Rarely, human hepatitis B immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatment with human immunoglobulin.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV. The measures taken may be of limited value against non-enveloped viruses such as HAV and/or parvovirus B19.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
It is strongly recommended that every time that GAMMA anty-HBs 200 is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
4.5 Interaction with other medicinal products and other forms of interaction
Live attenuated virus vaccines
Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines such as rubella, mumps, measles and varicella for a period of 3 months. After administration of this product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines. Human hepatitis B immunoglobulin should be administered three to four weeks after vaccination with such a live attenuated vaccine; in case administration of human hepatitis B immunoglobulin is essential within three to four weeks after vaccination, then revaccination should be performed three months after the administration of human hepatitis B immunoglobulin.
Interference with serological testing
After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient’s blood may result in misleading positive results in serological testing.
Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D may interfere with some serological tests for red cell antibodies, for example the antiglobulin test (Coombs’ test).
The listed interactions concern both adults and children.
4.6 Fertility, pregnancy and lactation
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore the product should be used with caution in pregnant or lactating women. It was demonstrated that immunoglobulins penetrate through the placenta, which is increased in the third trimester. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
Immunoglobulins are secreted into mother’s milk and may contribute to the protection of the newborn against pathogens that penetrate through mucous membranes.
Clinical experience with immunoglobulin use indicates that no harmful effect on fertility should be expected.
4.7 Effects on ability to drive and use machines
GAMMA anty-HBs 200 has no influence on the ability to drive and use machines.
4.8 Undesirable effects
As in case of any other product, GAMMA anty-HBs 200 may cause adverse reactions.
There is no sufficient data obtained in clinical trials concerning the frequency of undesirable effects. Frequencies of adverse effects have been evaluated according to the following convention:
very common (>1/10); common (≥ 1/100 to < 1/10); uncommon (≥1/1 000 to < 1/100), rare (≥1/10 000 to < 1/1 000), very rare (<1/10 000), not known (cannot be estimated from the available data). The table below was prepared in accordance with the MedDRA System Organ Classes classification (System Organ Classes and recommended terminology).
MedDRA System Organ Classes
Immune system disorders
Hypersensitivity, anaphylactic shock
very rare (including single cases)
Nervous system disorders
Skin and subcutaneous tissue disorders
Skin reaction, erythema, pruritus
Musculoskeletal and connective tissue disorders
General disorders and administration site conditions
Fever, malaise, chill
At injection site: swelling, pain, erythema, induration, warmth, pruritus, rash
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Pharmacovigilance Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warszawa, Phone: +48 22 49-21-301, fax: +48 22 49-21-309, email: email@example.com.
Adverse reactions can be also reported to marketing authorization holder.
See section 4.4 for safety information with reference to infectious agents.
Consequences of an overdose are not known.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Immune sera and immunoglobulins,
ATC code: J06BB04 Human hepatitis B immunoglobulin
GAMMA anty-HBs 200 contains mainly immunoglobulin G with a high content of antibodies against hepatitis B virus surface antigen (HBs).
5.2 Pharmacokinetic properties
Human hepatitis B immunoglobulin for intramuscular use is bioavailable in the recipient’s circulation after a delay of 2-3 days.
Human hepatitis B immunoglobulin has a half-life of about 3-4 weeks. This half-life may vary from patient to patient.
IgG and IgG-complexes are broken down in the reticuloendothelial system.
5.3 Preclinical safety data
In tests on laboratory animals (guinea pigs and white mice), no toxicity has been confirmed for GAMMA anty-HBs 200.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for injections
This medicinal product must not be mixed with other medicinal products.
6.3 Shelf life
6.4 Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Store the ampoules in the original package in order to protect from light.
6.5 Nature and contents of container
1 ml of the solution in type I glass ampoule – 1 per pack.
6.6 Special precautions for disposal and other handling
The product should be administered as intramuscular injection by the doctor or nurse.
The product should be brought to room or body temperature before use.
Check if the solution in the ampoule is clear or slightly opalescent.
Do not use solutions that are cloudy or have deposits. Reconstituted products should be inspected visually for particulate matter and discoloration prior to administration.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
„BIOMED-LUBLIN” Wytwórnia Surowic i Szczepionek Spółka Akcyjna
20-029 Lublin, ul. Uniwersytecka 10
tel 81 533 82 21
fax 81 533 80 60
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25 October 1990
Date of latest renewal: 21 August 2014
10. DATE OF REVISION OF THE TEXT