All the Active Ingredient Drugs
Human Hepatitis B Immunoglobulin 50 IU/ml. VIAL, sol. for infus. 2/10/40/100 ml Prevent. of hepat. B re-infect. after liver transplant. for hepat. B induced liver failure:
In adlts:
10 000 IU on the day of transplant., peri-operat. then 2000-10 000 IU (40-200 ml)/day for 7 days, and as necessary to maintain antibody levels above 100-150 IU/l in HBV-DNA negat. pts and above 500 IU/l in HBV-DNA posit. pts.
In childr: 10 000 IU/1.73 m2.
Immunoprophylaxis of hepat. B:
- Prevent. of hepat. B in case of accident. expos. in non-immunised subj.:
At least 500 IU (10 ml), depend. on the intens. of expos., asap after expos., preferably within 24 - 72 hs.
- Prevent. of hepat. B in the newborn, of a hepat. B virus carrier-mother, at birth or asap after birth: 30-100 IU (0.6-2 ml)/kg. The hepat. B immunoglobulin admin. may be repeated until seroconversion following vaccin.
In all these situat., vaccin. against hepat. B virus is highly recomm. The first vacc. dose can be inject. on the same day as human hepat. B immunoglobulin, in diff. sites.
In subj. who did not show an immune resp. (no measurable hepat. B antibodies) after vaccine, and for whom contin. prevent. is necessary, admin. of 500 IU (10 ml) to adlts and 8 IU (0.16 ml)/kg to childr. every 2 months can be considered; min. protect. antibody titre: 10 mIU/mL.
1. Prophyl. against hepat. B in adlts and childr over two years old who
have not been fully vacc. against hepat. B who are at risk of infect. with hepat. B by accident. contact with hepat. B virus contain. material following percutan. expos. or direct mucous membr. contact when administr. of an intramusc. hepat. B immunoglobulin is not possible. To be admin.in associat. with hepat. B vaccine.
2. Prophylaxis against re-infect. of a transplanted liver in pts who carry the surface antigen of the hepat. B virus
3. Immunoprophylaxis of hepat. B in the newborn of a hepat B virus carrier-mother.
C/I: Hypersens. Pts with select. IgA defic. who developed antibodies to IgA, as administr. of an IgA-contain. prod. can result in anaphylaxis.
Human Hepatitis B Immunoglobulin 50 IU/ml. I.V. VIAL: 1 x 100 ml x 50 IU/ml anti
HBsAg. 10,000 IU in anhepatic stage
(OLT foll. by 10,000 IU dly for 1st 5-7
days) aft. transplant. See lit.
Passive. immunizant. prevent hepatit. B
re-infect. aft. liver transplant. See lit.
C/I: Anaphylact. or severe system.
response to I.M./I.V. immunoglob. preps.
Not to be given with antibodies
to IgA or selective IgA defic.
Hepatitis Vaccines. Human Hepatitis B Immunoglobulin 500 IU. Sol. for SC inj. 5 pre-filled syringes of 1ml. In HBV-DNA neg. adlts at least one week after liver transplant.:
- sc inject. per week or fortnightly according to serum anti-HBs trough levels.
Prior to the init. of SC tmt., adequate anti-HBs serum levels should be stabiliz. with an IV hepat. B immunoglobulin to levels at or above 300-500 IU/L in order to ensure adeq. anti-HBs coverage during transit. from IV to SC dosing. Antibody levels >100 IU/L should be maint. in HBsAg and HBV-DNA negat. pts.
Dose can be indiv. establ. and adapt. from 500 IU up to 1,000 IU (in except. cases up to 1,500 IU) SC inject. on a weekly or fortnightly basis, according to the serum anti-HBs concentr. and at the discret. of the physician. Antibody levels >100 IU/L should be maint. Pts must be monit. for serum anti-HBs antibody levels regularly. Serum anti-HBs antibody levels should be meas. at least every 2-4 weeks for at least half a year.
Prevent. of hepat. B virus (HBV) re-infect. in HBsAg and HBV-DNA negat. adlt pts at least one week after liver transplant. for hepat. B induced liver failure..HBV-DNA negat. status should be confirm. within the last 3 months prior to OLT. Pts should be HBsAg negat. before tmt. start. Concom. use of adeq. virostatic agents should be considered as stand. of hepat. B re-infect. prophylaxis.
C/I: Hypersens. In partic., in very rare cases of IgA defic. when the ptt has antibodies against IgA. Must not be admin. IV.
