There can be variation in the licensing of
different medicines containing the same drug.
Paint
CAUTIONARY AND ADVISORY LABELS 15
▶Duofilm (GlaxoSmithKline Consumer Healthcare)
Lactic acid 150 mg per 1 gram, Salicylic acid 167 mg per
1 gram Duofilm paint | 15 ml p £2.78 DT = £2.78
▶Salactol (Dermal Laboratories Ltd)
Lactic acid 167 mg per 1 gram, Salicylic acid 167 mg per
1 gram Salactol paint | 10 ml p £1.71 DT = £1.71
Gel
CAUTIONARY AND ADVISORY LABELS 15
▶Salatac (Dermal Laboratories Ltd)
Lactic acid 40 mg per 1 gram, Salicylic acid 120 mg per
1 gram Salatac gel | 8 gram p £2.98 DT = £2.98
Chapter 14
Vaccines
CONTENTS
Immunoglobulin therapy
page 1354
Post-exposure prophylaxis
Immunoglobulin therapy
IMMUNE SERA AND IMMUNOGLOBULINS ›
IMMUNOGLOBULINS
Vaccines
Immunoglobulins
Passive immunity
Immunity with immediate protection against certain
infective organisms can be obtained by injecting
preparations made from the plasma of immune individuals
with adequate levels of antibody to the disease for which
protection is sought. The duration of this passive immunity
varies according to the dose and the type of
immunoglobulin. Passive immunity may last only a few
weeks; when necessary, passive immunisation can be
repeated. Antibodies of human origin are usually termed
immunoglobulins. The term antiserum is applied to material
prepared in animals. Because of serum sickness and other
allergic-type reactions that may follow injections of antisera,
this therapy has been replaced wherever possible by the use
of immunoglobulins. Reactions are theoretically possible
after injection of human immunoglobulins but reports of
such reactions are very rare.
Two types of human immunoglobulin preparation are
available, normal immunoglobulin p. 1358 and disease-
specific immunoglobulins.
Human immunoglobulin is a sterile preparation of
concentrated antibodies (immune globulins) recovered from
pooled human plasma or serum obtained from outside the
UK, tested and found non-reactive for hepatitis B surface
antigen and for antibodies against hepatitis C virus and
human immunodeficiency virus (types 1 and 2). A global
shortage of human immunoglobulin and the rapidly
increasing range of clinical indications for treatment with
immunoglobulins has resulted in the need for a Demand
Management programme in the UK, for further information
consult www.ivig.nhs.uk and Clinical Guidelines for
Immunoglobulin Use, www.gov.uk/dh.
Further information on the use of immunoglobulins is
included in Public Health England’s Immunoglobulin
Handbook, www.gov.uk/phe, and in the Department of
Health’s publication, Immunisation against Infectious Disease,
www.gov.uk/dh.
Availability
Normal immunoglobulin for intramuscular administration is
available from some regional Public Health laboratories for
protection of contacts and the control of outbreaks of
hepatitis A, measles, and rubella only. For other indications,
subcutaneous or intravenous normal immunoglobulin
should be purchased from the manufacturer.
Disease-specific immunoglobulins are available from
some regional Public Health laboratories, with the exception
of tetanus immunoglobulin p. 1360 which is available from
Tuberculosis diagnostic test
page 1361
Vaccination
BPL, hospital pharmacies, or blood transfusion departments.
Rabies immunoglobulin p. 1359 is available from the
Specialist and Reference Microbiology Division, Public
Health England, Colindale. Hepatitis B immunoglobulin
p. 1357 required by transplant centres should be obtained
commercially.
In Scotland all immunoglobulins are available from the
Scottish National Blood Transfusion Service (SNBTS).
In Wales all immunoglobulins are available from the Welsh
Blood Service (WBS).
In Northern Ireland all immunoglobulins are available
from the Northern Ireland Blood Transfusion Service (NIBTS).
Normal immunoglobulin
Human normal immunoglobulin (‘HNIG’) is prepared from
pools of at least 1000 donations of human plasma; it
contains immunoglobulin G (IgG) and antibodies to hepatitis
A, measles, mumps, rubella, varicella, and other viruses that
are currently prevalent in the general population.
Uses
Normal immunoglobulin (containing 10%–18% protein) is
administered by intramuscular injection for the protection of
susceptible contacts against hepatitis A virus (infectious
hepatitis), measles and, to a lesser extent, rubella. Injection
of immunoglobulin produces immediate protection lasting
several weeks.
Normal immunoglobulin (containing 3%–12% protein) for
intravenous administration is used as replacement therapy for
patients with congenital agammaglobulinaemia and
hypogammaglobulinaemia, and for the short-term treatment
of idiopathic thrombocytopenic purpura and Kawasaki
disease; it is also used for the prophylaxis of infection
following bone-marrow transplantation and in children with
symptomatic HIV infection who have recurrent bacterial
infections. Normal immunoglobulin for replacement therapy
may also be given intramuscularly or subcutaneously, but
intravenous formulations are normally preferred.
Intravenous immunoglobulin is also used in the treatment of
Guillain-Barré syndrome as an alternative to plasma
exchange.
For guidance on the use of intravenous normal
immunoglobulin and alternative therapies for certain
conditions, consult Clinical Guidelines for Immunoglobulin
Use (www.gov.uk/dh).
Hepatitis A
Hepatitis A vaccine p. 1388 is recommended for individuals
at risk of infection including those visiting areas where the
disease is highly endemic (all countries excluding Northern
and Western Europe, North America, Japan, Australia, and
New Zealand). In unimmunised individuals, transmission of
hepatitis A is reduced by good hygiene. Intramuscular
normal immunoglobulin is no longer recommended for
prophylaxis in travellers.
Public Health England recommends the use of normal
immunoglobulin in addition to hepatitis A vaccine for
prevention of infection in close contacts (of confirmed cases
of hepatitis A) who are 60 years of age or over, have chronic
liver disease (including chronic hepatitis B or C infection), or
HIV infection (with a CD4 count < 200 cells per microlitre),
or who are immunosuppressed; normal immunoglobulin
should be given as soon as possible, preferably within
14 days of exposure to the primary case. However, normal
immunoglobulin can still be given to contacts with chronic
liver disease up to 28 days after exposure to the primary case.
Hepatitis A vaccine can be given at the same time, but it
should be given at a separate injection site.
Measles
Intravenous or subcutaneous normal immunoglobulin may
be given to prevent or attenuate an attack of measles in
individuals who do not have adequate immunity. Patients
with compromised immunity who have come into contact
with measles should receive intravenous or subcutaneous
normal immunoglobulin as soon as possible after exposure.
It is most effective if given within 72 hours but can be
effective if given within 6 days.
Subcutaneous or intramuscular normal immunoglobulin
should also be considered for the following individuals if
they have been in contact with a confirmed case of measles
or with a person associated with a local outbreak:
. non-immune pregnant women
. infants under 9 months
Further advice should be sought from the Centre for
Infections, Public Health England (tel. (020) 8200 6868).
Individuals with normal immunity who are not in the
above categories and who have not been fully immunised
against measles, can be given measles, mumps and rubella
vaccine, live p. 1393 for prophylaxis following exposure to
measles.
Rubella
Intramuscular immunoglobulin after exposure to rubella
does not prevent infection in non-immune contacts and is
not recommended for protection of pregnant women
exposed to rubella. It may, however, reduce the likelihood of
a clinical attack which may possibly reduce the risk to the
fetus. Risk of intra-uterine transmission is greatest in the
first 11 weeks of pregnancy, between 16 and 20 weeks there
is minimal risk of deafness only, after 20 weeks there is no
increased risk. Intramuscular normal immunoglobulin
should be used only if termination of pregnancy would be
unacceptable to the pregnant woman—it should be given as
soon as possible after exposure. Serological follow-up of
recipients is essential to determine if the woman has become
infected despite receiving immunoglobulin.
For routine prophylaxis against Rubella, see measles,
mumps and rubella vaccine, live p. 1393.
Disease-specific immunoglobulins
Specific immunoglobulins are prepared by pooling the
plasma of selected human donors with high levels of the
specific antibody required. For further information, see
Immunoglobulin Handbook (www.gov.uk/phe).
There are no specific immunoglobulins for hepatitis A,
measles, or rubella— normal immunoglobulin p. 1358 is used
in certain circumstances. There is no specific
immunoglobulin for mumps; neither normal
immunoglobulin nor measles, mumps and rubella vaccine,
live is effective as post-exposure prophylaxis.
Hepatitis B immunoglobulin
Disease-specific hepatitis B immunoglobulin p. 1357
(‘HBIG’) is available for use in association with hepatitis B
vaccine p. 1389 for the prevention of infection in laboratory
and other personnel who have been accidentally inoculated
with hepatitis B virus, and in infants born to mothers who
have become infected with this virus in pregnancy or who are
high-risk carriers. Hepatitis B immunoglobulin will not
inhibit the antibody response when given at the same time
as hepatitis B vaccine but should be given at different sites.
An intravenous and subcutaneous preparation of hepatitis B
immunoglobulin is licensed for the prevention of hepatitis B
recurrence in HBV-DNA negative patients who have
undergone liver transplantation for liver failure caused by
the virus.
Rabies immunoglobulin
Following exposure of an unimmunised individual to an
animal in or from a country where the risk of rabies is high
the site of the bite should be washed with soapy water and
specific rabies immunoglobulin p. 1359 of human origin
administered. All of the dose should be injected around the
site of the wound; if this is difficult or the wound has
completely healed it can be given in the anterolateral thigh
(remote from the site used for vaccination).
Rabies vaccine p. 1394 should also be given
intramuscularly at a different site (for details see rabies
vaccine). If there is delay in giving the rabies
immunoglobulin, it should be given within 7 days of starting
the course of rabies vaccine.
Tetanus immunoglobulin
Vaccines
For the management of tetanus-prone wounds, tetanus
immunoglobulin p. 1360 should be used in addition to
wound cleansing and, where appropriate, antibacterial
prophylaxis and a tetanus-containing vaccine. Tetanus
immunoglobulin, together with metronidazole p. 572 and
wound cleansing, should also be used for the treatment of
established cases of tetanus.
Varicella–zoster immunoglobulin
Varicella-zoster immunoglobulin p. 1360 (VZIG) is
recommended for individuals who are at increased risk of
severe varicella (neonates, pregnant women and
immunosuppressed individuals with varicella-zoster virus
immunoglobulin G antibody less than 150 mIU/mL) and who
have no antibodies to varicella–zoster virus and who have
significant exposure to chickenpox (varicella) or shingles
(herpes zoster) during the infectious period.
Immunosuppressed patients receiving regular intravenous
immunoglobulin replacement therapy only require varicella-
zoster immunoglobulin if the most recent dose was
administered more than 3 weeks before exposure.
Immunosuppressed patients on long term aciclovir p. 670
or valaciclovir p. 673 prophylaxis will require a temporary
increase in their dose following exposure; for patients within
12 months of a stem cell transplant, varicella-zoster
immunoglobulin should also be considered.
Important: for full details consult Guidance for issuing
varicella-zoster immunoglobulin (VZIG) and Immunisation
against infectious disease from Public Health England
(www.gov.uk).
Anti-D (Rh0) immunoglobulin
Anti-D (Rh0) immunoglobulin p. 1356 is prepared from
plasma taken from rhesus-negative donors who have been
immunised against the anti-D-antigen. Anti-D (Rh0)
immunoglobulin is used to prevent a rhesus-negative
mother from forming antibodies to fetal rhesus-positive cells
which may pass into the maternal circulation. The objective
is to protect any subsequent child from the hazard of
haemolytic disease of the newborn.
Anti-D (Rh0) immunoglobulin should be administered to
the mother following any sensitising episode (e.g. abortion,
miscarriage and birth); it should be injected within 72 hours
of the episode but even if a longer period has elapsed it may
still give protection and should be administered. Anti-D
(Rh0) immunoglobulin is also given when significant feto-
maternal haemorrhage occurs in rhesus-negative women
during delivery. The dose of anti-D (Rh0) immunoglobulin is
determined according to the level of exposure to rhesus-
positive blood.
Use of routine antenatal anti-D prophylaxis should be
given irrespective of previous anti-D prophylaxis for a
sensitising event early in the same pregnancy. Similarly,
postpartum anti-D prophylaxis should be given irrespective
of previous routine antenatal anti-D prophylaxis or
antenatal anti-D prophylaxis for a sensitising event in the
same pregnancy.
Anti-D (Rh0) immunoglobulin is also given to women of
child-bearing potential after the inadvertent transfusion of
rhesus-incompatible blood components and is used for the
treatment of idiopathic thrombocytopenia purpura.
MMR vaccine
Measles, mumps and rubella vaccine, live may be given in
the postpartum period with anti-D (Rh0) immunoglobulin
injection provided that separate syringes are used and the
products are administered into different limbs. If blood is
transfused, the antibody response to the vaccine may be
inhibited—measure rubella antibodies after 6–8 weeks and
revaccinate if necessary.
PDF pages 1375, 1376, 1377, 1378