SUMMARY OF MEDICINAL PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
GAMMA anty-HBs 200
Solution for injection
Immunoglobulinum humanum hepatitidis B Human hepatitis B immunoglobulin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
I ml of the solution contains:
Human hepatitis B immunoglobulin 200 IU.
For excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection
Transparent or slightly opalescent solution.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Immunoprophylaxis against Hepatitis B
– newborns of mothers with Hepatitis B
– children up to 50 kg of weight, especially exposed to the risk of HBV nonsocomial infection.
Posology and method of administration
Gamma anty-HBs 200 should be administered intramuscularly:
l) to newborns whose mothers had Hepatitis B while pregnant or are HBs antigen carriers, 200 IU are administered within max. 12 hours after birth,
2) to newborns not vaccinated against Hepatitis B; 1 month after the first dose (200 IU) the second dose of 200 IU is administered,
3) to children up to 50 kg of weight, the medicine is administered as follows:
– to newborns, infants and children up to 10 kg of weight, 200 IU are administered (1 ampoule),
– to children from 10 to 20 kg of weight, 400 IU are administered (2 ampoules),
– to children from 20 to 30 kg of weight, 600 IU are administered (3 ampoules),
– to children from 30 to 50 kg of weight, 800 IU are administered (4 ampoules).
In the case of a long hospital stay of a child, the dose is repeated every 3-4 weeks.
In such situations, vaccination against Hepatitis B is highly recommended. The first dose of the vaccine can be administered on the same day as human immunoglobulin against Hepatitis B, however in different sites.
In the case of a dose exceeding 400 IU (more than 2 ampoules), the product should be administered intramuscularly in 2 different sites.
If it is necessary to administer the vaccine at the same time, immunoglobulin and the vaccine should be injected in two different sites.
If contraindications for intramuscular injections exist (coagulation impairment), the product can be administered subcutaneously, provided that no product for intravenous administration is available. It should be noted, however, that no clinical data about efficiency of subcutaneous administration of GAMMA anty-HBs 200 is available.
Contraindications for use include:
– hypersensitivity to human immunoglobulin, especially in patients with immunoglobulin A deficiency and circulating anti-IgA antibodies,
– known hypersensitivity to any of the product components.
Gamma anty-HBs 200 must not be administered intravenously.
4.4 Special warnings and precautions for use
Make sure GAMMA anty-HBs 200 is not administered directly to a blood vessel due to the risk of shock.
If the recipient carries HBsAg, product administration does not produce any benefits.
Hypersensitivity reactions occur seldom,
Sometimes, human immunoglobulin against Hepatitis B evokes a drop in blood pressure combined with anaphylactic reactions even in the case of patients who tolerated previous treatment with human immunoglobulin.
In the case of suspected allergic or anaphylactic reaction, product injection should be discontinued immediately. In the case of shock, a standard medical procedure should be followed.
Gamma anty-HBs 200 is derived from human plasma collected from donors with a high level of anti-HBs antibodies. The manufacturing technique is based on the fractionation of plasma with cold ethyl alcohol according to the Cohn procedure. In the case of administration of products obtained from human blood or plasma, the transmission of infectious agents cannot be completely excluded. This refers also to pathogens and viruses unknown before. However, the risk of transmitting infectious agents is minimised by:
– selection of donors based on clinical anamnesis and testing of both, a single plasma unit and pooled plasma for the presence of HBsAg, anti-HIV and anti-HCV antibodies.
– testing of pooled plasma for the presence of the genetic material from the virus of hepatitis type C (HCV).
– applied inactivation/elimination of viruses in the manufacturing process, validated using model viruses.
Undertaken safety measures which are considered as efficient apply to enveloped viruses, such as: HIV, 1–1BV and HCV. However, they can have a limited efficiency for non-enveloped viruses, such as virus of hepatitis type A (HAV) and/or parvovirus B 19.
Clinical data exists which confirms lack of transfer of hepatitis A virus (HAV) and B19 parvovirus during immunoglobulin use. Also, the presence of antibodies is presumed to play an important role for viral safety of the product.
It is recommended, for patient’s safety, as far as possible, to record the name and lot number of the Gamma anty-HBs 200 product together with the patient data after each application of the medicine, in order to correlate the product lot number to a given patient.
4.5 Interaction with other medicinal products and other forms of interaction
Vaccines containing live attenuated viruses
Administration of immunoglobulin may affect may disturb the development of immune response to vaccines containing live attenuated viruses, such as rubella, mumps, measles or chicken pox, for a period of 3 months. The administration of this product should be followed by at least a 3-month pause before the administration of a vaccine containing live attenuated viruses.
Human immunoglobulin against Hepatitis B should be administered three to four weeks following administration of a vaccine containing live attenuated viruses; if administration of immunoglobulin against Hepatitis B is vital in the period of three to four weeks after vaccination, another vaccine should be administered 3 months after administration of immunoglobulin against Hepatitis B.
Disturbance of serological tests
After injecting immunoglobulin, a temporary increase in the levels of various passively transferred antibodies in the patient’s blood may be observed, which may result in falsely positive results of serological tests.
Passive transfer of antibodies against antigens of erythrocytes, e.g. A, B, D, may impair the results of some serological tests for the presence of antibodies reacting with red blood cells, e.g. direct antiglobulin test (Coombs test).
4.6 Fertility, pregnancy and lactation
4.7 Effects on ability to drive and use machines
Gamma anty-HBs 200 has no effects on the ability to drive or use machines.
4.8 Undesirable effects
Like all medicines, Gamma anty-HBs 200 can cause adverse reactions.
There is no sufficient clinical data about the frequency of occurrence of adverse reactions. The following adverse reactions have been observed:
Classification of systems and organs compliant with
MedDRA system Adverse reactions Frequency
Immune system disorders Hypersensitivity, anaphylactic shock very rare ((<1/10 000 including isolated cases Nervous system disorders Headaches rare (≥1/10 000 <1/1 000) Cardiac disorders Tachycardia No data available Vascular disorders Lower blood pressure rare (≥1/1O 000 <1/1 000) Gastrointestinal disorders Nausea vomiting rare (≥1/1O 000 <1/1 000) Skin and subcutaneous tissue disorders Skin reactions, erythema, pruritus rare (≥1/1O 000 <1/1 000) Musculoskeletal and connective tissue disorders Arthralgia rare (≥1/1O 000 <1/1 000) General disorders and conditions at the site of injection Fever, ill-being, shivers rare (≥1/1O 000 <1/1 000) At the injection site: oedema, pain, erythema, induration, burning sensation, pruritus, rash rare (≥1/1O 000 <1/1 000)Viral safety, see section 4.4. 4.9 Overdose Overdosing symptoms are unknown.5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Immune sera and immunoglobulins, ATC code: J06BB04 Human immunoglobulin against Hepatitis B Gamma anty-HBs contains mainly immunoglobulins G with a high level of antibodies against HBV surface antigen (HBs antigen). 5.2 Pharmacokinetic properties Human immunoglobulin against Hepatitis B for intramuscular injections is biologically available in the recipient's cardiovascular system after 2-3 days following administration. The half-life of human immunoglobulin against Hepatitis B is approx. 3-4 weeks. Half-life may be different for different patients. IgG and IgG complexes undergo decomposition in the reticuloendothelial system, 5.3 Preclinical safety data No toxicity of the product Gamma anty-HBs 200 has been observed in tests on laboratory animals (guinea pigs and white mice).6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Glycine Sodium chloride Water for injections 6.2 Incompatibilities The product must not be mixed with other medicinal products. 6.3 Shelf life 18 months. 6.4 Special precautions for storage Store at 2 oC - 8 o C (in a refrigerator). In order to protect the ampoules from light store them in the outer carton. 6.5 Nature and contents of container I ml of the solution in an ampoule made of type I glass packed individually. 6.6 Special precautions for disposal of a medicinal product and other handling The product should be administered in an intramuscular injection by a physician or nurse. Before use, the product should be brought to room or body temperature. The solution in an ampoule should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits. Any unused product or waste material should be disposed of in accordance with local regulations.7. MARKETING AUTHORISATION HOLDER „BIOMED-LUBLIN" Wytwórnia Surowic i Szczepionek Spółka Akcyjna 20-029 Lublin, 111. Uniwersytecka 108. MARKETING AUTHORISATION NUMBER(S) 2550 NR-R/0609 R/06099. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25.10.1990 Date of renewal: 08.02.1999, 07.04.2004, 11.12.2008, 21.08.2014 10. DATE OF APPROVAL OR PARTIAL REVISION OF THE TEXT CONCERNING SUMMARY OF MEDICINAL PRODUCT CHARACTERISTICS 01/2015