PRIVIGEN ® Hyperprolinaemia (contains L-proline)
FLEBOGAMMA ® DIF Hereditary fructose intolerance
HIZENTRA ® Hyperprolinaemia (contains L-proline)
GAMMAPLEX ® Hereditary fructose intolerance (contains
l CAUTIONS Agammaglobulinaemia with or without IgA
deficiency . hypogammaglobulinaemia with or without IgA
deficiency . interference with live virus vaccines
▶ Interference with live virus vaccines Normal immunoglobulin
may interfere with the immune response to live virus
vaccines which should therefore only be given at least
3 weeks before or 3 months after an injection of normal
immunoglobulin (this does not apply to yellow fever
vaccine since normal immunoglobulin does not contain
OCTAGAM ® Falsely elevated results with blood glucose
testing systems (contains maltose)
l INTERACTIONS → Appendix 1: immunoglobulins
▶ With intramuscular use Chills
▶ With intramuscular use Dizziness .fatigue .feeling hot. headache . nausea . pain . skin reactions
▶ With subcutaneous use Paraesthesia
▶ With intramuscular use Chest discomfort. dyspnoea . facial
SIDE-EFFECTS, FURTHER INFORMATION Adverse reactions
are more likely to occur in patients receiving normal
immunoglobulin for the first time, or following a
prolonged period between treatments, or when a different
brand of normal immunoglobulin is administered.
l MONITORING REQUIREMENTS Monitor for acute renal
failure; consider discontinuation if renal function
deteriorates. Intravenous preparations with added sucrose
have been associated with cases of renal dysfunction and
l DIRECTIONS FOR ADMINISTRATION
Preparations for subcutaneous use May be administered by
intramuscular injection if subcutaneous route not
possible; intramuscular route not for patients with
thrombocytopenia or other bleeding disorders.
GAMUNEX ® Use Glucose 5% intravenous infusion if
dilution prior to infusion is required.
KIOVIG ® Use Glucose 5% intravenous infusion if dilution
prior to infusion is required.
l PRESCRIBING AND DISPENSING INFORMATION Antibody
titres can vary widely between normal immunoglobulin
preparations from different manufacturers—formulations
are not interchangeable; patients should be maintained
on the same formulation throughout long-term treatment
▶ With intramuscular use Available from the Centre for
Infections and other regional Public Health England
offices (for contacts and control of outbreaks only).
l HANDLING AND STORAGE Care must be taken to store all
immunological products under the conditions
recommended in the product literature, otherwise the
preparation may become ineffective. Refrigerated
storage is usually necessary; many immunoglobulins need
to be stored at 2–8°C and not allowed to freeze.
Immunoglobulins should be protected from light. Opened
multidose vials must be used within the period
recommended in the product literature.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
ELECTROLYTES: May contain Sodium
▶ Hizentra (CSL Behring UK Ltd)
Normal immunoglobulin human 200 mg per 1 ml Hizentra
2g/10ml solution for injection pre-filled syringes | 1 pre-filled
disposable injection P £108.00
▶ Subgam (Bio Products Laboratory Ltd)
Normal immunoglobulin human 160 mg per 1 ml Subgam
1.5g/9.375ml solution for injection vials | 1 vial P £75.00
Subgam 4g/25ml solution for injection vials | 1 vial P £200.00
Subgam 2g/12.5ml solution for injection vials | 1 vial P £100.00
Subgam 1g/6.25ml solution for injection vials | 1 vial P £50.00
Subgam 750mg/4.6875ml solution for injection vials | 1 vial P £37.50
EXCIPIENTS: May contain Glucose, maltose, sorbitol, sucrose
▶ Normal immunoglobulin (Non-proprietary)
Normal immunoglobulin human 100 mg per 1 ml Normal
immunoglobulin human 5g/50ml solution for infusion vials | 1 vial P s
Normal immunoglobulin human 2.5g/25ml solution for infusion vials
Normal immunoglobulin human 20g/200ml solution for infusion vials
Normal immunoglobulin human 10g/100ml solution for infusion vials
Normal immunoglobulin human 30g/300ml solution for infusion vials
▶ Flebogammadif (Grifols UK Ltd)
Normal immunoglobulin human 50 mg per 1 ml Flebogamma DIF
10g/200ml solution for infusion vials | 1 vial P £510.00
Flebogamma DIF 2.5g/50ml solution for infusion vials | 1 vial P £127.50
Flebogamma DIF 5g/100ml solution for infusion vials | 1 vial P £255.00
Flebogamma DIF 500mg/10ml solution for infusion vials | 1 vial P £30.00
Flebogamma DIF 20g/400ml solution for infusion vials | 1 vial P £1,020.00
▶ Gammaplex (Bio Products Laboratory Ltd)
Normal immunoglobulin human 50 mg per 1 ml Gammaplex
10g/200ml solution for infusion vials | 1 vial P £418.00 (Hospital
Gammaplex 5g/100ml solution for infusion vials | 1 vial P £209.00 (Hospital only)
Gammaplex 20g/400ml solution for infusion vials | 1 vial P £836.00 (Hospital only)
Normal immunoglobulin human 100 mg per 1 ml Gamunex 10%
1g/10ml solution for infusion vials | 1 vial P £42.50
Gamunex 10% 10g/100ml solution for infusion vials | 1 vial P £425.00
Gamunex 10% 20g/200ml solution for infusion vials | 1 vial P £850.00
Gamunex 10% 5g/50ml solution for infusion vials | 1 vial P £212.50
▶ Hizentra (CSL Behring UK Ltd)
Normal immunoglobulin human 200 mg per 1 ml Hizentra
2g/10ml solution for infusion vials | 1 vial P £108.00
Hizentra 1g/5ml solution for infusion vials | 1 vial P £54.00
Hizentra 4g/20ml solution for infusion vials | 1 vial P £216.00
Normal immunoglobulin human 100 mg per 1 ml Kiovig 5g/50ml
solution for infusion vials | 1 vial P £245.00
Kiovig 20g/200ml solution for infusion vials | 1 vial P £980.00
Kiovig 10g/100ml solution for infusion vials | 1 vial P £490.00
Kiovig 30g/300ml solution for infusion vials | 1 vial P £1,470.00
Kiovig 2.5g/25ml solution for infusion vials | 1 vial P £122.50
BNF 78 Immunoglobulin therapy 1291
Kiovig 1g/10ml solution for infusion vials | 1 vial P £49.00
Normal immunoglobulin human 50 mg per 1 ml Octagam 5%
10g/200ml solution for infusion bottles | 1 bottle P £480.00
Octagam 5% 5g/100ml solution for infusion bottles | 1 bottle P £240.00 (Hospital only)
Normal immunoglobulin human 100 mg per 1 ml Octagam 10%
10g/100ml solution for infusion bottles | 1 bottle P £690.00
Octagam 10% 20g/200ml solution for infusion bottles | 1 bottle P £1,380.00 (Hospital only)
Octagam 10% 5g/50ml solution for infusion bottles | 1 bottle P £345.00 (Hospital only)
Octagam 10% 2g/20ml solution for infusion vials | 1 vial P £138.00 (Hospital only)
Normal immunoglobulin human 100 mg per 1 ml Panzyga
10g/100ml solution for infusion bottles | 1 bottle P £586.50
Panzyga 20g/200ml solution for infusion bottles | 1 bottle P £1,173.00 (Hospital only)
Panzyga 5g/50ml solution for infusion bottles | 1 bottle P £293.25 (Hospital only)
▶ Privigen (CSL Behring UK Ltd)
Normal immunoglobulin human 100 mg per 1 ml Privigen
5g/50ml solution for infusion vials | 1 vial P £270.00
Privigen 20g/200ml solution for infusion vials | 1 vial P £1,080.00
Privigen 10g/100ml solution for infusion vials | 1 vial P £540.00
Privigen 2.5g/25ml solution for infusion vials | 1 vial P £135.00
Post-exposure prophylaxis against rabies infection
▶ BY LOCAL INFILTRATION, OR BY INTRAMUSCULAR INJECTION
▶ Child: 20 units/kg, dose administered by infiltration in
and around the cleansed wound; if the wound not
visible or healed or if infiltration of whole volume not
possible, give remainder by intramuscular injection
into anterolateral thigh (remote from vaccination site)
▶ Adult: 20 units/kg, dose administered by infiltration in
and around the cleansed wound; if the wound not
visible or healed or if infiltration of whole volume not
possible, give remainder by intramuscular injection
into anterolateral thigh (remote from vaccination site)
l CAUTIONS IgA deficiency . interference with live virus
l INTERACTIONS → Appendix 1: immunoglobulins
illness . malaise . nausea . skin reactions .tachycardia . vomiting
l PRESCRIBING AND DISPENSING INFORMATION The potency
of individual batches of rabies immunoglobulin from the
manufacturer may vary; potency may also be described
differently by different manufacturers. It is therefore
critical to know the potency of the batch to be used and
the weight of the patient in order to calculate the specific
volume required to provide the necessary dose.
Available from Specialist and Reference Microbiology
Division, Public Health England (also from BPL).
l HANDLING AND STORAGE Care must be taken to store all
immunological products under the conditions
recommended in the product literature, otherwise the
preparation may become ineffective. Refrigerated
storage is usually necessary; many immunoglobulins need
to be stored at 2–8°C and not allowed to freeze.
Immunoglobulins should be protected from light. Opened
multidose vials must be used within the period
recommended in the product literature.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Rabies immunoglobulin (Non-proprietary)
Rabies immunoglobulin human 500 unit Rabies immunoglobulin
human 500unit solution for injection vials | 1 vial P £800.00
▶ Child: Initially 250 units, then increased to 500 units,
dose is only increased if more than 24 hours have
elapsed or there is risk of heavy contamination or
▶ Adult: Initially 250 units, then increased to 500 units,
dose is only increased if more than 24 hours have
elapsed or there is risk of heavy contamination or
Treatment of tetanus infection
▶ Child: 150 units/kg, dose may be given over multiple
▶ Adult: 150 units/kg, dose may be given over multiple
l CAUTIONS IgA deficiency . interference with live virus
l INTERACTIONS → Appendix 1: immunoglobulins
▶ Rare or very rare Anaphylactic reaction . hypotension
l HANDLING AND STORAGE Care must be taken to store all
immunological products under the conditions
recommended in the product literature, otherwise the
preparation may become ineffective. Refrigerated
storage is usually necessary; many immunoglobulins need
to be stored at 2–8°C and not allowed to freeze.
Immunoglobulins should be protected from light. Opened
multidose vials must be used within the period
recommended in the product literature.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Tetanus immunoglobulin (Non-proprietary)
Tetanus immunoglobulin human 250 unit Tetanus immunoglobulin
human 250unit solution for injection vials | 1 vial P £170.00
Varicella-zoster immunoglobulin
(Antivaricella-zoster Immunoglobulin)
Prophylaxis against varicella infection
▶ BY DEEP INTRAMUSCULAR INJECTION
▶ Adult: 1 g, to be administered as soon as possible—not
later than 10 days after exposure, second dose to be
given if further exposure occurs more than 3 weeks
after first dose, no evidence that effective in severe
l CAUTIONS IgA deficiency . interference with live virus
l INTERACTIONS → Appendix 1: immunoglobulins
reactions .tachycardia . vomiting
1292 Immunoglobulin therapy BNF 78
l DIRECTIONS FOR ADMINISTRATION Normal
immunoglobulin for intravenous use may be used in those
unable to receive intramuscular injections.
l PRESCRIBING AND DISPENSING INFORMATION Available
from selected Public Health England and NHS laboratories
l HANDLING AND STORAGE Care must be taken to store all
immunological products under the conditions
recommended in the product literature, otherwise the
preparation may become ineffective. Refrigerated
storage is usually necessary; many immunoglobulins need
to be stored at 2–8°C and not allowed to freeze.
Immunoglobulins should be protected from light. Opened
multidose vials must be used within the period
recommended in the product literature.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Varicella-Zoster (Bio Products Laboratory Ltd)
Varicella-Zoster immunoglobulin human 250 mg Varicella-Zoster
immunoglobulin human 250mg solution for injection vials | 1 vial P £600.00
IMMUNE SERA AND IMMUNOGLOBULINS ›
l DRUG ACTION Bezlotoxumab is a human monoclonal
antitoxin antibody; it binds to Clostridium difficile toxin B
and neutralises its activity, preventing recurrence of
Clostridium difficile infection.
Prevention of recurrence of Clostridium difficile infection
in patients at high risk of reinfection
▶ Adult: 10 mg/kg for 1 dose, to be administered during
the course of antibacterial therapy for Clostridium
l PREGNANCY Manufacturer advises avoid unless
essential—limited information available.
l BREAST FEEDING Manufacturer advises avoid—no
l DIRECTIONS FOR ADMINISTRATION Manufacturer advises
for intravenous infusion (Zinplava ®), give intermittently in
Glucose 5 % or Sodium Chloride 0.9 %; dilute requisite
dose to a concentration of 1–10 mg/mL with infusion fluid;
give over 60 minutes via a central venous catheter or
peripheral catheter using a low-protein binding filter
l HANDLING AND STORAGE Manufacturer advises store in a
refrigerator (2–8 °C)—consult product literature for
further information regarding storage conditions outside
refrigerator and after preparation of the infusion.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Polysorbates
ELECTROLYTES: May contain Sodium
▶ Zinplava (Merck Sharp & Dohme Ltd) A
Bezlotoxumab 25 mg per 1 ml Zinplava 1g/40ml concentrate for
solution for infusion vials | 1 vial P £2,470.00
l DRUG ACTION A preparation containing the specific
antitoxic globulins that have the power of neutralising the
toxins formed by types A, B, and E of Clostridium
Post exposure prophylaxis of botulism
▶ Adult: (consult product literature)
l SIDE-EFFECTS Hypersensitivity
SIDE-EFFECTS, FURTHER INFORMATION It is essential to
read the contra-indications, warnings, and details of
sensitivity tests on the package insert. Prior to treatment
checks should be made regarding previous administration
of any antitoxin and history of any allergic condition, e.g.
l PRE-TREATMENT SCREENING All patients should be tested
for sensitivity (diluting the antitoxin if history of allergy).
l PRESCRIBING AND DISPENSING INFORMATION Available
from local designated centres, for details see TOXBASE
(requires registration) www.toxbase.org. For supplies
outside working hours apply to other designated centres or
to the Public Health England Colindale duty doctor (Tel
(020) 8200 6868). For major incidents, obtain supplies
The BP title Botulinum Antitoxin is not used because the
preparation currently in use may have a different
l MEDICINAL FORMS No licensed medicines listed.
Passive immunisation in suspected cases of diphtheria
▶ Adult: Dose should be given without waiting for
bacteriological confirmation (consult product
▶ Hypersensitivity Hypersensitivity is common after
administration; resuscitation facilities should be available.
Diphtheria antitoxin is no longer used for prophylaxis
because of the risk of hypersensitivity; unimmunised
contacts should be promptly investigated and given
antibacterial prophylaxis and vaccine.
▶ Common or very common Hypersensitivity
l PRE-TREATMENT SCREENING Diphtheria antitoxin is
derived from horse serum and reactions are common; tests
for hypersensitivity should be carried out before use.
l PRESCRIBING AND DISPENSING INFORMATION Available
from Centre for Infections (Tel (020) 8200 6868) or in
Northern Ireland from Public Health Laboratory, Belfast
City Hospital (Tel (028) 9032 9241).
BNF 78 Post-exposure prophylaxis 1293
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Diphtheria antitoxin (Non-proprietary)
Diphtheria antitoxin 1000 unit per 1 ml Antidiphtheria serum
10,000units/10ml solution for injection ampoules |
Tuberculin purified protein derivative
Mantoux test (if first test is negative and a further test is
DOSE EQUIVALENCE AND CONVERSION
▶ 2 units is equivalent to 0.1 mL of 20 units/mL strength.
▶ 10 units is equivalent to 0.1 mL of 100 units/mL
▶ Mantoux test Response to tuberculin may be suppressed by
viral infection, sarcoidosis, corticosteroid therapy, or
immunosuppression due to disease or treatment and the
MMR vaccine. If a tuberculin skin test has already been
initiated, then the MMR should be delayed until the skin
test has been read unless protection against measles is
required urgently. If a child has had a recent MMR, and
requires a tuberculin test, then a 4 week interval should be
observed. Apart from tuberculin and MMR, all other live
vaccines can be administered at any time before or after
l PRESCRIBING AND DISPENSING INFORMATION Available
The strength of tuberculin PPD in currently available
products may be different to the strengths of products
used previously for the Mantoux test; care is required to
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: solution for
▶ Tuberculin purified protein derivative (Non-proprietary)
Tuberculin purified protein derivative 20 tuberculin unit per
1 ml Tuberculin PPD RT 23 SSI 20 tuberculin units/ml solution for
injection 1.5ml vials | 1 vial s
Tuberculin purified protein derivative 100 tuberculin unit per
1 ml Tuberculin PPD RT 23 SSI 100 tuberculin units/ml solution for
injection 1.5ml vials | 1 vial s
Vaccination, general principles
Active immunity can be acquired by natural disease or by
vaccination. Vaccines stimulate production of antibodies
and other components of the immune mechanism; they
. a live attenuated form of a virus (e.g. measles, mumps and
rubella vaccine) or bacteria (e.g. BCG vaccine), or
. inactivated preparations of the virus (e.g. influenza
. detoxified exotoxins produced by a micro-organism (e.g.
. extracts of a micro-organism, which may be derived from
the organism (e.g. pneumococcal vaccine) or produced by
recombinant DNA technology (e.g. hepatitis B vaccine).
Live attenuated vaccines usually produce a durable
immunity, but not always as long-lasting as that resulting
Inactivated vaccines may require a primary series of
injections of vaccine to produce an adequate antibody
response, and in most cases booster (reinforcing) injections
are required; the duration of immunity varies from months
to many years. Some inactivated vaccines are adsorbed onto
an adjuvant (such as aluminium hydroxide) to enhance the
HIV-positive individuals with or without symptoms can
receive the following live vaccines:
. MMR (but avoid if immunity significantly impaired; use of
normal immunoglobulin should be considered after
exposure to measles), varicella-zoster vaccine against
chickenpox (but avoid if immunity significantly impaired—
consult product literature; varicella–zoster
immunoglobulin should be considered after exposure to
chickenpox or herpes zoster), rotavirus;
and the following inactivated vaccines:
. anthrax, cholera (oral), diphtheria, haemophilus
influenzae type b, hepatitis A, hepatitis B, human
papillomavirus, influenza (injection), meningococcal,
pertussis, pneumococcal, poliomyelitis, rabies, tetanus,
tick-borne encephalitis, typhoid (injection).
HIV-positive individuals should not receive:
. BCG, influenza nasal spray (unless stable HIV infection
and receiving antiretroviral therapy), typhoid (oral), yellow
fever (if yellow fever risk is unavoidable, specialist advice
The above advice differs from that for other
immunocompromised patients; Immunisation Guidelines for
HIV-infected Adults issued by British HIV Association (BHIVA)
The following vaccines are recommended for asplenic
patients, those with splenic dysfunction or complement
disorders, depending on the age at which their condition is
. Haemophilus influenzae type b with meningococcal group
. Meningococcal groups A with C and W135 and Y vaccine
p. 1315 and meningococcal group B vaccine (rDNA,
Comments
Post a Comment
اكتب تعليق حول الموضوع