Human hepatitis B immunoglobulin.
Each mL of solution for injection contains human protein immunoglobulin (at least 95%) 100-170 mg, with antibodies to HBs antigen at least 200 IU.
It also contains the following excipients: Aminoacetic acid (glycine), sodium chloride, HCl or NaOH (in small amounts for pH adjustment), water for injections.
Immune sera and immunoglobulins, human hepatitis B immunoglobulin. ATC Code: J06B B04.
Immunoprophylaxis of hepatitis B in case of accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or status unknown); in haemodialysed patients, until vaccination has become effective; in the newborn of a hepatitis B virus carrier-mother or a mother with unknown HbsAg-status; in subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.
National and/or World Health Organization (WHO) guidelines regarding protection against hepatitis B immunoglobulin should be observed.
Prevention of Hepatitis B in Case of Accidental Exposure in Non-Immunised Subjects (Including Persons Whose Vaccination is Incomplete or Status Unknown): 12 IU/kg bodyweight (bw), at least 500 IU, depending on the intensity of exposure, as soon as possible after exposure, and preferably within 72 hrs.
Immunoprophylaxis of Hepatitis B in Haemodialysed Patients: 8-12 IU/kg bw (maximal 500 IU), every 2 months until seroconversion following vaccination.
Prevention of Hepatitis B in the Newborn, of a Hepatitis B Virus Carrier-Mother, at Birth or As Soon As Possible After Birth: 30-100 IU/kg bw (normally 1 mL). The hepatitis B immunoglobulin administration may need to be repeated until seroconversion following vaccination.
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 bw to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 MIU/mL.
Administration: Human hepatitis B immunoglobulin should be administered via the IM route.
Do not use solutions which are cloudy or contain residues (deposits/particles).
Hepatitis B Immunoglobulin P Behring is a ready-to-use solution and should be administered at body temperature.
If comparatively large volumes are required it is advisable to administer them in divided fractions. This applies in the case of doses >2 mL for children up to 20 kg bw and doses >5 mL for persons >20 kg bw.
In case of simultaneous prophylaxis the immunoglobulin and the vaccine should be administered at contralateral sites of the body.
In the presence of a severe coagulation disorder, in the case of which IM injections are contraindicated, Hepatitis B Immunoglobulin P Behring may also be given SC. Afterwards, the injection site should be compressed with a swab.
However, it should be noted that there are no clinical efficacy data to support administration by the SC route.
Hypersensitivity to human immunoglobulins or to any of the components of Hepatitis B Immunoglobulin P Behring.
If the recipient is a carrier of HbsAg, there is no benefit in administering Hepatitis B Immunoglobulin P Behring.
Do not inject intravasculary.
Ensure that Hepatitis B Immunoglobulin P Behring is not administered into a blood vessel because of the risk of shock.
True hypersensitivity reactions are rare. Hepatitis B Immunoglobulin P Behring 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.
Rarely human hepatitis B immunoglobulin can induce a fall in blood pressure with anaphylactic reactions, even in patients who had tolerated previous treatment with human immunoglobulin.
Therapeutic measures depend on the nature and severity of the event. The current medical standards for shock treatment are to be observed.
Patients should be observed for at least 20 mins after administration of Hepatitis B Immunoglobulin P Behring.
Particularly in cases of inadvertent IV injection, patients should be observed for longer term (at least 1 hr) after administration.
Important information about some of the ingredients of Hepatitis B Immunoglobulin P Behring: It contains <1 mmol (23 mg) sodium per dose ie, essentially “sodium free”.
Virus Safety: 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 eg, HIV, HBV and HCV, and for the non-enveloped viruses HAV and 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 Hepatitis B Immunoglobulin P Behring 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.
Effects on the Ability to Drive or Operate Machinery: No effects on the ability to drive and use machines have been observed.
Use in pregnancy & lactation: The safety of Hepatitis B Immunoglobulin P Behring for use in human pregnancy has not been established in controlled clinical trials. Long lasting clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, on the foetus or the neonate are to be expected.
The safety of Hepatitis B Immunoglobulin P Behring for use in human pregnancy has not been established in controlled clinical trials. Long lasting clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, on the foetus or the neonate are to be expected.
In rare cases the following adverse reactions may occur: Allergic reactions including fall in blood pressure, dyspnoea, cutaneous reactions, in isolated cases reaching as far as anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration of immunoglobulins; generalized reactions eg, chills, fever, headache, malaise, nausea, vomiting, arthralgia and moderate back pain; cardiovascular reactions particularly if the product is inadvertently injected intravascularly.
At the injection site local pain, tenderness or swelling can be observed in rare cases.
For safety with respect to transmissible agents, see Precautions.
If patient experience reactions, especially those which are not mentioned, inform the physician or pharmacist.
Vaccinations with Live Attenuated Virus Vaccines: Immunoglobulin administration may impair the efficacy of live attenuated virus vaccines eg, measles, rubella, mumps and varicella vaccines for a period of up to 3 months. Human hepatitis B immunoglobulin should be administered 3-4 weeks at the earliest after vaccination with such a live attenuated vaccine; in case administration of human hepatitis B immunoglobulin is essential within 3-4 weeks after vaccination, then revaccination should be performed 3 months after the administration of human hepatitis B immunoglobulin.
Interference with Serological Testing: It has to be considered that when serological test results are interpreted, the transitory rise of passively transferred antibodies after immunoglobulin injection may result in misleading positive test results.
Passive transmission of antibodies to erythrocyte antigens eg, A, B and D may interfere with some serological tests for red cell allo-antibodies (eg, Coombs' test).
Incompatibilities: In the absence of compatibility studies, Hepatitis B Immunoglobulin P Behring must not be mixed with other medicinal products, diluents or solvents.
Store at +2°C to +8°C (refrigerator). Do not freeze. Protect from light.
Once the container has been opened, the contents have to be used immediately.
Any unused product or waste material should be disposed of in accordance with local requirements.
J06BB04 - hepatitis B immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Pre-filled syringe 200 IU/mL x 1's.