Posology : מינונים

DOSAGE AND ADMINISTRATION

Recommendations on post-exposure prophylaxis are based on available efficacy data and on the likelihood of future HBV exposure for the person requiring treatment. In all exposures, a regimen combining Hepatitis B Immunoglobulin with hepatitis B vaccine will provide both short-and long- term protection, will be less costly than the two-dose Hepatitis B Immunoglobulin treatment alone, and is the treatment of choice. [16]

Acute Exposure to Blood Containing HBsAg [17]

Table 1 summarizes prophylaxis for percutaneous (needlestick or bite), ocular, or mucous- membrane exposure to blood according to the source of exposure and vaccination status of the exposed person. For greatest effectiveness, passive prophylaxis with Hepatitis B Immunoglobulin should be given as soon as possible after exposure (its value beyond 7 days of exposure is unclear). If Hepatitis B Immunoglobulin is indicated (see Table 1), an injection of 0.06 mL/kg of body weight should be administered intramuscularly (see PRECAUTIONS) as soon as possible after exposure and within 24 hours, if possible. Consult Hepatitis B Vaccine package insert for dosage information regarding that product.

Table 1. (adapted from [18]) Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure


Source             Unvaccinated                                        Vaccinated HBsAG-Positive     1. Hepatitis B Immunoglobulin                       1. Test exposed person for anti- (Human) x 1 immediately*                            HBs.
2. Initiate HB Vaccine Series†                      2. If inadequate antibody,‡
Hepatitis B Immunoglobulin (x1) immediately plus HB Vaccine booster dose, or 2 doses of
HBIG,* one as soon as possible after exposure and the second 1 month later.
Known Source       1. Initiate HB Vaccine Series                       1. Test Source for HBsAg only (High Risk)        2. Test source of HBsAg. If positive, Hepatitis B   if exposed is vaccine Immunoglobulin x 1                                  nonresponder; if source is HBsAg-positive, give Hepatitis
B Immunoglobulin x 1 immediately plus HB Vaccine booster dose, or 2 doses of
HBIG*, one as soon as possible after exposure and the second 1 month later.

Low Risk            Initiate HB Vaccine series                               Nothing required.
HBsAg-Positive

Unknown             Initiate HB Vaccine series within 7 days of exposure     Nothing required.
Source
* Hepatitis B Immunoglobulin, dose 0.06 mL / kg IM.
† HB Vaccine dose 20 g IM for adults; 10 g IM for infants or children under 10 years of age. First dose within 1 week; second and third doses, 1 and 6 months later.
‡ Less than 10 sample ratio units (SRU) by radioimmunoassay (RIA), negative by enzyme immunoassay (EIA).

For persons who refuse Hepatitis B Vaccine, a second dose of Hepatitis B Immunoglobulin should be given 1 month after the first dose.

Prophylaxis of Infants Born to HBsAg and HBeAg Positive Mothers

Efficacy of prophylactic Hepatitis B Immunoglobulin in infants at risk depends on administering Hepatitis B Immunoglobulin on the day of birth. It is therefore vital that HBsAg-positive mothers be identified before delivery.

Hepatitis B Immunoglobulin (0.5 mL) should be administered intramuscularly (IM) to the newborn infant after physiologic stabilization of the infant and preferably within 12 hours of birth. Hepatitis B Immunoglobulin efficacy decreases markedly if treatment is delayed beyond 48 hours. Hepatitis B Vaccine should be administered IM in three doses of 0.5 mL of vaccine (10 µg) each. The first dose should be given within 7 days of birth and may be given concurrently with Hepatitis B Immunoglobulin but at a separate site. The second and third doses of vaccine should be given 1 month and 6 months, respectively, after the first. If administration of the first dose of Hepatitis B Vaccine is delayed for as long as 3 months, then a 0.5 mL dose of Hepatitis B Immunoglobulin should be repeated at 3 months. If Hepatitis B Vaccine is refused, the 0.5 mL dose of Hepatitis B Immunoglobulin should be repeated at 3 and 6 months. Hepatitis B Immunoglobulin administered at birth should not interfere with oral polio and diphtheria-tetanus-pertussis vaccines administered at 2 months of age. [17]

Sexual Exposure to an HBsAg-positive Person

All susceptible persons whose sex partners have acute hepatitis B infection should receive a single dose of HBIG (0.06 mL/kg) and should begin the hepatitis B vaccine series if prophylaxis can be started within 14 days of the last sexual contact or if sexual contact with the infected person will continue (see Table 2 below). Administering the vaccine with HBIG may improve the efficacy of postexposure treatment. The vaccine has the added advantage of conferring long- lasting protection. [16]

Table 2. (adapted from [19]) Recommendations for Postexposure Prophylaxis for Sexual Exposure to Hepatitis B

HBIG*                                       Vaccine
Dose                 Recommended timing          Dose         Recommended timing Single dose within 14 days of last sexual                      First dose at time of
0.06 mL/kg IM†       contact
1.0 mL IM†
HBIG* treatment‡


*
HBIG = Hepatitis B Immunoglobulin
†
IM = intramuscularly
‡
The first dose can be administered the same time as the HBIG dose but at a different site; subsequent doses should be administered as recommended for the specific vaccine.

Household Exposure to Persons with Acute HBV Infection

Prophylactic treatment with a 0.5 mL dose of Hepatitis B Immunoglobulin and hepatitis B vaccine is indicated for infants < 12 months of age who have been exposed to a primary care-giver who has acute hepatitis B. Prophylaxis for other household contacts of persons with acute HBV infection is not indicated unless they have had identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive hepatitis B vaccine. [16]

Hepatitis B Immunoglobulin may be administered at the same time (but at a different site), or up to 1 month preceding Hepatitis B Vaccination without impairing the active immune response from Hepatitis B Vaccination. [14]

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Administer intramuscularly. Do not inject intravenously.

Hepatitis B Immunoglobulin– HyperHEP B® S/D is supplied in a syringe with an attached needle guard for your protection and convenience, as well as in vials. Please follow instructions below for proper use of syringe and needle guard.

Directions for Syringe Usage

1. Remove the prefilled syringe from the package. Lift syringe by barrel, not by plunger.
2. Twist the plunger rod clockwise until the threads are seated.
3. With the rubber needle shield secured on the syringe tip, push the plunger rod forward a few millimeters to break any friction seal between the rubber stopper and the glass syringe barrel.
4. Remove the needle shield and expel air bubbles. [Do not remove the rubber needle shield to prepare the product for administration until immediately prior to the anticipated injection time.] 5. Proceed with hypodermic needle puncture.
6. Aspirate prior to injection to confirm that the needle is not in a vein or artery.
7. Inject the medication.
8. Keeping your hands behind the needle, grasp the guard with free hand and slide forward toward needle until it is completely covered and guard clicks into place. If audible click is not heard, guard may not be completely activated. (See Diagrams A and B)
9. Place entire prefilled glass syringe with guard activated into an approved sharps container for proper disposal. (See Diagram C)



A number of factors could reduce the efficacy of this product or even result in an ill effect following its use. These include improper storage and handling of the product after it leaves our hands, diagnosis, dosage, method of administration and biological differences in individual patients.
Because of these factors, it is important that this product be stored properly and that the directions be followed carefully during use.