REVAXIS™ | v01 | 1/12
patient group direction
R E V A X I S ™ ( D I P H T H E R I A , T E TA N U S A N D P O L I O M Y E L I T I S
( I N A C T I VAT E D ) VA C C I N E ( A D S O R B E D , R E D U C E D A N T I G E N ( S ) C O N T E N T ) )
PGD Details
Version
1.0
Legal category
POM
Staff grades
Paramedic (Non-ECP)
Nurse (Non-ECP)
Emergency Care Practitioner (Paramedic)
Emergency Care Practitioner (Nurse)
Approved by
Medicines Management Group
Date issued
01/02/2013
Review date
31/01/2015
Clinical
Publication
Category
Mandatory (RED) - No deviation from document
permissible
Clinical Requirements
❙❙ Successful completion of a competency assessment in
the use of this medicine for the indications stated;
❙❙ Completion of education in both the legal and
professional aspects of PGD administration and the
supply of medicines;
Competencies
❙❙ Registered paramedics must have successfully
completed a recognised Emergency Care Practitioner
course;
❙❙ Registered nurses must be employed as Nurse
Practitioners or have successfully completed a
recognised Emergency Care Practitioner course.
Continuing
education
❙❙ The clinician is responsible for keeping him/herself
aware of any changes to the recommendations for the
medicine listed. It is the responsibility of the individual
to keep up-to-date with continued professional
development and to work within the limitations of their
own individual scope of practice.
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REVAXIS™ | v01 | 2/12
patient group direction
Clinical Situation
Clinical situation
❙❙ Revaxis™ is indicated for active immunisation against
tetanus as a result of an infected wound in adults and
children aged 10 years of age and over.
For immunisation against tetanus following any wounds in
any adult or child aged 10 years and over where:
❙❙ The immunisation status of the patient is unknown
(try to ascertain by phoning GP surgery when patient
presents ‘in hours’);
❙❙ There is an incomplete history of a primary course of
tetanus. In these cases further doses of Revaxis™ will be
needed to complete the schedule and these should be
arranged via the patient’s own GP surgery;
❙❙ The boosters are not up to date;
❙❙ The patient is an intravenous drug user;
❙❙ The wound is tetanus prone. This includes:
Inclusion criteria
▲▲ Any wound or burn that requires surgical intervention
that is delayed for more than 6 hours;
▲▲ Any wound or burn in patients who have systemic
sepsis;
▲▲ Any wound or burn at any interval after injury that
shows one or more of the following characteristics:
●● a significant degree of devitalised tissue;
●● a puncture type wound;
●● contact with soil or manure;
●● wounds containing foreign bodies;
●● compound fractures.
NB: The vaccine may be administered to breast feeding
women if they fall under any of the above inclusion criteria.
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❙❙ Primary immunisation;
❙❙ Children under 10 years;
❙❙ Legal consent has not been obtained;
❙❙ Previous dose of vaccine given within the last 28 days;
❙❙ If Guillain-Barres Syndrome or brachial neuritis has
occurred following receipt of prior vaccine containing
tetanus toxoid;
❙❙ Patients who have had a true anaphylactic reaction to a
previous dose of diphtheria, tetanus and poliomyelitis;
Exclusion criteria
❙❙ Patients who have had a true anaphylactic reaction to
neomycin, streptomycin or polymixin B (vaccine may
contain small amounts of these antibiotics);
❙❙ Hypersensitivity to any other component of the vaccine;
❙❙ Patients who may have reduced immunity such as:
▲▲ Patients on high dose steroids (e.g; prednisolone:
adults at least 40mg daily for more than 1 week;
children 2mg/kg daily for at least 1 week or 1mg/kg
daily for 1 month);
▲▲ Patients receiving chemotherapy;
▲▲ Patients receiving generalised radiotherapy;
❙❙ If the patient has a fever or suffering from an acute
severe systemic illness;
❙❙ Pregnant women.
Cautions
❙❙ Bleeding may occur in patients with thrombocytopaenia
or a bleeding disorder following an Intra-muscular
injection. In these conditions Revaxis™ may be
administered as a deep subcutaneous injection;
❙❙ Appropriate medical treatment should be readily
available for immediate use in case of an anaphylactic
reaction following vaccination.
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patient group direction
Very Common:
❙❙ Local Injection site pain, erythema, induration, oedema
and occasionally injection site nodules. Onset is usually
within 48 hours following vaccination and persists for
1-2 days.
Common:
❙❙ Headache;
❙❙ Vertigo;
❙❙ Nausea/ vomiting;
❙❙ Pyrexia.
Uncommon:
❙❙ Lymphadenopathy;
❙❙ Myalgia;
❙❙ Malaise.
Side effects
Rare:
❙❙ Arthralgia.
Very Rare:
❙❙ Convulsions;
❙❙ Guillain-Barre Syndrome;
❙❙ Brachial Neuritis;
❙❙ Transient parasthesia;
❙❙ Hypothesia of the vaccinated limb;
❙❙ Vaso-vagal syncope;
❙❙ Abdominal pain/ diarrhoea;
❙❙ Urticaria, various types of rash and facial oedema;
❙❙ Pain in vaccinated limb;
❙❙ Anaphylactic reactions;
❙❙ Large injection site reactions (>50mm) including
extensive limb swelling from the injection site beyond
one or more joints.
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REVAXIS™ | v01 | 5/12
patient group direction
❙❙ If patient meets exclusion criteria refer to medical
practitioner;
Action if
excluded
❙❙ Seek specialist advice from GP, A&E, Public Health or
Health Protection Agency to evaluate the risk to the
individual of not being immunised;
❙❙ Record in patient clinical record the reason for exclusion
and any action taken.
Action if patient
declines
❙❙ If patient declines treatment or advice, ensure the
patient clinical record details:
▲▲ The advice given by the clinician;
▲▲ Details of any referral made;
▲▲ The intended actions of the patient (including parent
or guardian).
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REVAXIS™ | v01 | 6/12
patient group direction
Description of Treatment
Generic name
Revaxis™ (Diphtheria, tetanus and poliomyelitis
(inactivated) vaccine (adsorbed, reduced antigen(s)
content).
Presentation
Suspension for injection in a 0.5ml pre-filled syringe. The
suspension has a cloudy white appearance.
Route
Intra-muscular injection into the deltoid muscle in the
upper arm.
Administration Supply
Method
❙❙ Before administration check that the vaccine has been
properly stored. This includes checking the refrigerator
temperature records to ensure that the vaccine has
been stored within the manufacturer’s recommended
temperature ranges. Vaccine which has not been stored
correctly must not be used;
❙❙ Shake vaccine well immediately before use. Inspect
the vaccine for extraneous particulate matter and
discolouration prior to use. After agitation the vaccine is
a slightly opaque, white solution.
Dose
0.5ml.
❙❙ A single booster dose to previously immunised adults
and children aged 10 years and over;
Frequency
Duration of
treatment
Storage
instructions
❙❙ A single booster dose to adults and children 10 years
and over with an incomplete history or no history of a
primary course of tetanus. Advise patient to follow up
with the GP practice to complete any further doses if
required.
Single dose.
❙❙ Store between +2C to +8C in a refrigerator;
❙❙ If vaccine has been frozen it should be discarded;
❙❙ Store in original package in order to protect from light.
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REVAXIS™ | v01 | 7/12
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Follow Up
❙❙ Ensure that there is a communication to the patient’s
registered GP to inform him/her about the consultation,
the outcomes of that consultation and any treatment
given using local mechanisms. This information must
also be available to other healthcare professionals
who may be required to administer care to the patient
following the consultation;
Referral
arrangements
and safety
netting
❙❙ The use of Revaxis™ was recommended by the
Department of Health in recognition of a national
shortage of tetanus immunoglobulin (TIG). Acute
hospitals have limited supplies of TIG. However:
▲▲ Individuals with tetanus prone wounds and an
unknown immunisation status, incomplete history of
primary course of tetanus or if the boosters are not
up to date, will require a tetanus immunoglobulin
in addition to the tetanus booster and should
be referred to the A&E Department for the
Immunoglobulin;
▲▲ Individuals who are fully immunised and those whose
primary immunisation is complete will require the
immunoglobulin if the risk of infection is especially
high such as contamination with soil or manure.
❙❙ Allergic reactions are always a rare possibility after
receiving a vaccine and may include:
▲▲ difficulty in breathing;
▲▲ blue discolouration of the tongue or lips;
▲▲ swelling of the face or throat;
▲▲ low blood pressure (causing dizziness);
▲▲ fainting (collapse).
Advice to
patients
❙❙ When these signs or symptoms occur they usually
develop very quickly after the injection is given and
while the person affected is still in the clinic. If any of
these symptoms occur after administering the injection,
the patient must be advised to consult a doctor
IMMEDIATELY.
❙❙ Dizziness (vertigo) has been reported after vaccination.
If you feel dizzy after having the vaccine, you should not
drive or operate machinery.
Records
❙❙ Complete patient clinical record.
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REVAXIS™ | v01 | 8/12
patient group direction
❙❙ British National Formulary (BNF) 64, September 2012;
References
❙❙ Revaxis Summary of product characteristics (Accessed at
http://www.emc.medicines.org.uk).
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REVAXIS™ | v01 | 9/12
patient group direction
Authorisation
Chief Executive
Officer
Medical
Director
Name
Signature
Name
Signature
Date
01/02/2013
Date
01/02/2013
Date
01/02/2013
Dr Andy Smith
Signature
Name
Pharmaceutical
Advisor
Ken Wenman
Sue Oakley
❙❙ This patient group direction must be signed by the Chief Executive Officer,
Medical Director and Pharmaceutical Advisor to be legally valid.
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REVAXIS™ | v01 | 10/12
patient group direction
Individual Authorisation (Staff Copy)
Name
Individual
Signature
Date
/ / Date
/ / Name
Authorising officer
Signature
❙❙ I have read and understood the Patient Group Direction and agree to
administer this medicine only in accordance with this document.
❙❙ PGDs do not remove inherent professional obligations or accountability. It is
the responsibility of each professional to practice only within the bounds of
their own competence and in accordance with their own Code of Professional
Conduct.
❙❙ This signed page must be retained by the member of staff, together with the
full PGD, which must be available in clinical practice.
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patient group direction
Individual Authorisation (Trust Copy)
Name
Individual
Signature
Date
/ / Date
/ / Name
Authorising officer
Signature
❙❙ I have read and understood the Patient Group Direction and agree to
administer this medicine only in accordance with this document.
❙❙ PGDs do not remove inherent professional obligations or accountability. It is
the responsibility of each professional to practice only within the bounds of
their own competence and in accordance with their own Code of Professional
Conduct.
❙❙ This signed page must be retained by the member of staff, together with the
full PGD, which must be available in clinical practice.
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