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11 Skin cleansers, antiseptics, and desloughing agents

11 Skin cleansers, antiseptics, and desloughing agents

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596



13.11.1 Alcohols and saline



emulsifying ointment (section 13.2.1) can be used in

place of soap or detergent for cleansing dry or irritated

skin.

An antiseptic is used for skin that is infected or that is

susceptible to recurrent infection. Detergent preparations containing chlorhexidine or povidone–iodine,

which should be thoroughly rinsed off, are used. Emollients may also contain antiseptics (section 13.2.1).



Sodium Chloride (Non-proprietary)

Solution (sterile), sodium chloride 0.9%, net price 25

6 20-mL unit = £5.50, 200–mL can = £2.65, 1 litre

= 97p

Flowfusor® (Fresenius Kabi)

Solution (sterile), sodium chloride 0.9%, net price

120-mL Bellows Pack = £1.53



Antiseptics such as chlorhexidine or povidone–iodine

are used on intact skin before surgical procedures; their

antiseptic effect is enhanced by an alcoholic solvent.

Antiseptic solutions containing cetrimide can be used if

a detergent effect is also required.



Irriclens® (ConvaTec)

Solution in aerosol can (sterile), sodium chloride

0.9%, net price 240-mL can = £3.30



Preparations containing alcohol, and regular use of

povidone-iodine, should be avoided on neonatal skin

(see section 13.1).



Irripod® (C D Medical)

Solution (sterile), sodium chloride 0.9%, net price 25

6 20-mL sachet = £5.50



Hydrogen peroxide, an oxidising agent, is available as a

cream and can be used for superficial bacterial skin

infections.

For irrigating ulcers or wounds, lukewarm sterile sodium chloride 0.9% solution is used but tap water is

often appropriate.

Potassium permanganate solution 1 in 10 000, a mild

antiseptic with astringent properties, can be used as a

soak for exudative eczematous areas (section 13.5.1);

treatment should be stopped when the skin becomes

dry. Potassium permanganate can stain skin and nails

especially with prolonged use.



13.11.1 Alcohols and saline

ALCOHOL

Cautions flammable; avoid broken skin; patients have

suffered severe burns when diathermy has been preceded by application of alcoholic skin disinfectants

Contra-indications neonates, see section 13.1

Indications and dose

Skin preparation before injection

Apply to skin as necessary



13 Skin



BNFC 2013–2014



Industrial Methylated Spirit, BP

Solution, 19 volumes of ethanol and 1 volume

approved wood naphtha, net price ‘66 OP’ (containing 95% by volume alcohol) 100 mL = 39p; ‘74 OP’

(containing 99% by volume alcohol) 100 mL = 39p.

Label: 15

Surgical Spirit, BP

Spirit, methyl salicylate 0.5 mL, diethyl phthalate

2%, castor oil 2.5%, in industrial methylated spirit,

net price 100 mL = 20p. Label: 15



SODIUM CHLORIDE

Indications and dose

See notes above

Nebuliser diluent section 3.1.5

Sodium depletion section 9.2.1.2

Electrolyte imbalance section 9.2.2.1



Miniversol® (Aguettant)

Solution (sterile), sodium chloride 0.9%, net price 30

6 45-mL unit = Ê13.20; 30 6 100-mL unit =

Ê19.50

Normasolđ (Moălnlycke)

Solution (sterile), sodium chloride 0.9%, net price 25

6 25-mL sachet = £6.14; 10 6 100-mL sachet =

£7.47

Stericlens® (C D Medical)

Solution in aerosol can (sterile), sodium chloride

0.9%, net price 100-mL can = £1.94, 240-mL can =

£2.95

Steripod® Sodium Chloride (Medlock)

Solution (sterile), sodium chloride 0.9%, net price 25

6 20-mL sachet = £7.57



13.11.2 Chlorhexidine salts

CHLORHEXIDINE

Cautions avoid contact with eyes, brain, meninges

and middle ear; not for use in body cavities; alcoholic

solutions not suitable before diathermy or for use on

neonatal skin

Side-effects occasional sensitivity

Indications and dose

See under preparations

Bladder irrigation and catheter patency solutions

section 7.4.4

Chlorhexidine 0.05% (Baxter)

2000 Solution (sterile), pink, chlorhexidine acetate

0.05%, net price 1000 mL = £0.77

For cleansing and disinfecting wounds and burns



Cepton® (LPC)

Skin wash (= solution), red, chlorhexidine gluconate

1%, net price 150 mL = £2.89

For use as skin wash in acne



Eye section 11.8.1



Lotion, blue, chlorhexidine gluconate 0.1%, net price

150 mL = £2.48



Oral hygiene section 12.3.4



For skin disinfection in acne



BNFC 2013–2014



13.11.3 Cationic surfactants and soaps



ChloraPrep® (CareFusion)

Cutaneous solution, sterile, chlorhexidine gluconate

2% in isopropyl alcohol 70%, net price (all with single applicator) 0.67 mL (with SEPP ® applicator) =

30p, 1.5 mL (with FREPP ® applicator) = 55p, 1.5 mL

= 78p, 3 mL = 85p, 10.5 mL = £2.92, 26 mL =

£6.50; (all with single applicator, with tint) 3 mL =

90p, 10.5 mL = £3.07, 26 mL = £6.83

For skin disinfection before invasive procedures; Child

under 2 months not recommended

Note Flammable



CX Antiseptic Dusting Powder® (Ecolab)

Dusting powder, sterile, chlorhexidine acetate 1%,

net price 15 g = Ê3.93



597



Concentrates

Hibitaneđ Plus 5% Concentrate (Moălnlycke)

Solution, red, chlorhexidine gluconate 5%, in a perfumed aqueous solution, net price 5 litres = £14.50

Dose



Pre-operative skin preparation

Dilute 1 in 10 (0.5%) with alcohol 70%



General skin disinfection

Dilute 1 in 100 (0.05%) with water

Note Alcoholic solutions not suitable for use before

diathermy (see Alcohol, p. 596) or on neonatal skin



For skin disinfection



Hibiscrubđ (Moălnlycke)

Cleansing solution, red, chlorhexidine gluconate 4%,

perfumed, in a surfactant solution, net price 250 mL

= £4.25, 500 mL = £5.25, 5 litres = £24.00

Excipients include fragrance

Use instead of soap for pre-operative hand and skin

preparation and for general hand and skin disinfection



Hibiđ Liquid Hand Rub+ (Moălnlycke)

Solution, chlorhexidine gluconate 0.5%, in isopropyl

alcohol 70% with emollients, net price 500 mL =

£5.25

To be used undiluted for hand and skin disinfection



Hibitane Obstetric® (Derma UK)

Cream, chlorhexidine gluconate solution 5% (: 1%

chlorhexidine gluconate), in a pourable water-miscible basis, net price 250 mL = £9.00



13.11.3 Cationic surfactants and

soaps

CETRIMIDE

Cautions avoid contact with eyes; avoid use in body

cavities

Side-effects skin irritation and occasionally sensitisation

Indications and dose

Skin disinfection

Preparations

Ingredient of Tisept ® and Travasept ® 100, see above



For use in obstetrics and gynaecology as an antiseptic and

lubricant (for application to skin around vulva and

perineum and to hands of midwife or doctor)



Hydrex® (Ecolab)

Solution, chlorhexidine gluconate solution 2.5% (:

chlorhexidine gluconate 0.5%), in denatured ethanol

70%, net price 600 mL (clear) = £3.49; 600 mL

(pink) = £3.49, 200-mL spray = £1.77, 500-mL spray

= £3.01

Note Flammable

For pre-operative skin disinfection



Surgical scrub, chlorhexidine gluconate 4% in a surfactant solution, net price 250 mL = £3.39, 500 mL

= £3.59



Unisept® (Medlock)

Solution (sterile), pink, chlorhexidine gluconate

0.05%, net price 25 6 25-mL sachet = £5.40; 10 6

100-mL sachet = £6.67

For cleansing and disinfecting wounds and burns and

swabbing in obstetrics



With cetrimide

Tisept® (Medlock)

Solution (sterile), yellow, chlorhexidine gluconate

0.015%, cetrimide 0.15%, net price 25 6 25-mL

sachet = £5.20; 10 6 100-mL sachet = £6.68

To be used undiluted for general skin disinfection and

wound cleansing



Travasept 100® (Baxter)

Solution (sterile), yellow, chlorhexidine acetate

0.015%, cetrimide 0.15%, net price 500 mL = 72p,

1 litre = 77p

To be used undiluted in skin disinfection such as wound

cleansing and obstetrics



POVIDONE–IODINE

Cautions broken skin (see below)

Large open wounds The application of povidone–iodine to

large wounds or severe burns may produce systemic adverse

effects such as metabolic acidosis, hypernatraemia, and

impairment of renal function



Contra-indications postmenstrual age under 32

weeks; infants body-weight under 1.5 kg; regular use

in neonates; thyroid disorders; concomitant lithium

treatment

Renal impairment avoid regular application to

inflamed or broken skin or mucosa

Pregnancy sufficient iodine may be absorbed to affect

the fetal thyroid in the second and third trimester

Breast-feeding avoid regular or excessive use

Side-effects rarely sensitivity; may interfere with

thyroid function tests

Indications and dose

Skin disinfection see preparations

Betadine® (Ayrton Saunders)

Dry powder spray, povidone–iodine 2.5% in a pressurised aerosol unit, net price 150-g unit = £2.63

For skin disinfection, particularly minor wounds and

infections; Child under 2 years not recommended

Note Not for use in serous cavities



Savlon® Dry (Novartis Consumer Health)

Powder spray, povidone–iodine 1.14% in a pressurised aerosol unit, net price 50-mL unit = £2.39

For minor wounds



13 Skin



Excipients include fragrance

For pre-operative hand and skin preparation and for

general hand disinfection



13.11.4 Iodine



598



13.11.5 Phenolics



Videne® (Ecolab)

Alcoholic tincture, povidone–iodine 10%, net price

500 mL = £3.46

Dose

Apply undiluted in pre-operative skin disinfection

Note Flammable—caution in procedures involving hot wire

cautery and diathermy; avoid use in neonates



Antiseptic solution, povidone–iodine 10% in

aqueous solution, net price 500 mL = £3.46

Dose

Apply undiluted in pre-operative skin disinfection and

general antisepsis



Surgical scrub, povidone–iodine 7.5% in aqueous

solution, net price 500 mL = £3.46

Dose

Use as a pre-operative scrub for hand and skin disinfection



BNFC 2013–2014

Permitabs® (Alliance)

Solution tablets, for preparation of topical solution,

potassium permanganate 400 mg, net price 30-tab

pack = £12.97

Note 1 tablet dissolved in 4 litres of water provides a 0.01%

(1 in 10 000) solution



13.11.7 Desloughing agents

Alginate, hydrogel, and hydrocolloid dressings (see BNF

Appendix 5) are effective in wound debridement. Sterile

larvae (maggots) (available from BioMonde) are also

used for managing sloughing wounds and are prescribable on the NHS.

Desloughing solutions and creams are of little clinical

value. Substances applied to an open area are easily

absorbed and perilesional skin is easily sensitised.

For further information on wound management products and elastic hosiery, see BNF Appendix 5.



13.11.5 Phenolics

Triclosan has been used for disinfection of the hands

and wounds, and for disinfection of the skin before

surgery.



13.11.6 Oxidisers and dyes



13 Skin



HYDROGEN PEROXIDE

Cautions large or deep wounds; avoid on healthy skin

and eyes; bleaches fabric; incompatible with products

containing iodine or potassium permanganate

Licensed use licensed for use in children (age range

not specified by manufacturer)

Indications and dose

Superficial bacterial skin infection see under preparation below

Crystacide® (Derma UK)

Cream, hydrogen peroxide 1%, net price 25 g =

£8.07, 40 g = £11.62

Excipients include edetic acid (EDTA), propylene glycol

Dose



Superficial bacterial skin infection

Apply 2–3 times daily for up to 3 weeks



POTASSIUM PERMANGANATE

Cautions irritant to mucous membranes

Indications and dose

Cleansing and deodorising suppurating eczematous reactions (section 13.5.1) and wounds

For wet dressings or baths, use approx. 0.01% (1 in

10 000) solution

Note Stains skin and clothing



Potassium Permanganate Solution

Solution, potassium permanganate 0.1% (1 in 1000)

in water

Note to be diluted 1 in 10 to provide a 0.01% (1 in 10 000)

solution



13.12



Antiperspirants



Aluminium chloride is a potent antiperspirant used in

the treatment of axillary, palmar, and plantar hyperhidrosis. Aluminium salts are also incorporated in preparations used for minor fungal skin infections associated with hyperhidrosis.

In more severe cases specialists use tap water or glycopyrronium bromide (as a 0.05% solution) in the iontophoretic treatment of hyperhidrosis of palms and soles.

Botox ® contains botulinum toxin type A complex (section 4.9.3) and is available for use intradermally for

severe hyperhidrosis of the axillae unresponsive to

topical antiperspirant or other antihidrotic treatment;

intradermal treatment is unlikely to be tolerated by most

children and should be administered under hospital

specialist supervision.



ALUMINIUM SALTS

Cautions avoid contact with eyes or mucous membranes; avoid use on broken or irritated skin; do not

shave axillae or use depilatories within 12 hours of

application; avoid contact with clothing

Side-effects skin irritation

Licensed use licensed for use in children (age range

not specified by manufacturer)

Indications and dose

Hyperhidrosis affecting axillae, hands or feet

Apply liquid formulation at night to dry skin, wash

off the following morning, initially apply daily then

reduce frequency as condition improves—do not

bathe immediately before use

Hyperhidrosis, bromidrosis, intertrigo, and prevention of tinea pedis and related conditions

Apply powder to dry skin

Anhydrol® Forte (Dermal)

Solution (= application), aluminium chloride hexahydrate 20% in an alcoholic basis, net price 60-mL

bottle with roll-on applicator = £2.51. Label: 15

Excipients none as listed in section 13.1.3



BNFC 2013–2014



13.13 Topical circulatory preparations



599



Driclor® (Stiefel)

Application, aluminium chloride hexahydrate 20% in

an alcoholic basis, net price 75-mL bottle with rollon applicator = £3.01. Label: 15

Excipients none as listed in section 13.1.3

Note A 30-mL pack is on sale to the public



ZeaSORB® (Stiefel)

Dusting powder, aldioxa 0.22%, chloroxylenol 0.5%,

net price 50 g = £2.61

Excipients include fragrance



GLYCOPYRRONIUM BROMIDE

Cautions see notes (Antimuscarinics) in section 1.2

(but poorly absorbed and systemic effects unlikely)

Contra-indications see notes (Antimuscarinics) in

section 1.2 (but poorly absorbed and systemic effects

unlikely); also infections affecting the treatment site

Side-effects see notes (Antimuscarinics) in section

1.2 (but poorly absorbed and systemic effects unlikely); also tingling at administration site

Licensed use licensed for use in children (age range

not specified by manufacturer)

Indications and dose

Iontophoretic treatment of hyperhidrosis

Consult product literature; only 1 site to be treated

at a time, max. 2 sites treated in any 24 hours,

treatment not to be repeated within 7 days

Other indications section 15.1.3

Robinul® (Mercury) A

Powder, glycopyrronium bromide, net price 3 g =

£175.00



13.13



Topical circulatory

preparations



Hirudoid® (Genus) U

Cream, heparinoid 0.3% in a vanishing-cream basis,

net price 50 g = £3.99

Excipients include cetostearyl alcohol, hydroxybenzoates

(parabens)

Dose



Superficial thrombophlebitis, bruising, and haematoma

Child 5–18 years apply up to 4 times daily



Gel, heparinoid 0.3%, net price 50 g = £3.99

Excipients include propylene glycol, fragrance

Dose



Superficial thrombophlebitis, bruising, and haematoma

Child 5–18 years apply up to 4 times daily



13 Skin



These preparations are used to improve circulation in

conditions such as bruising and superficial thrombophlebitis but are of little value. First aid measures such

as rest, ice, compression, and elevation should be used.

Topical preparations containing heparinoids should not

be used on large areas of skin, broken or sensitive skin,

or mucous membranes. Chilblains are best managed by

avoidance of exposure to cold; neither systemic nor

topical vasodilator therapy is established as being effective.



600



BNFC 2013–2014



14 Immunological products

and vaccines

14.1

14.2

14.3

14.4

14.5



Active immunity



600



Passive immunity



603



Storage and use



603



Vaccines and antisera



603



Immunoglobulins

623

623

14.5.1 Normal Immunoglobulin

14.5.2 Disease-specific immunoglobulins



14.5.3 Anti-D (Rh0) immunoglobulin



14.6



International travel



14 Immunological products and vaccines



14.1



625

627



627



Active immunity



Active immunity can be acquired by natural disease or

by vaccination. Vaccines stimulate production of antibodies and other components of the immune mechanism; they consist of either:

1.



a live attenuated form of a virus (e.g. measles,

mumps, and rubella vaccine) or bacteria (e.g.

BCG vaccine), or



2.



inactivated preparations of a virus (e.g. influenza

vaccine) or bacteria, or



3.



detoxified exotoxins produced by a micro-organism

(e.g. tetanus vaccine), or



4.



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 durable

immunity but not always as long-lasting as that resulting

from natural infection.

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 antibody response.

Advice in this chapter reflects that in the handbook

Immunisation against Infectious Disease (2006), which

in turn reflects the guidance of the Joint Committee

on Vaccination and Immunisation (JCVI).

Chapters from the handbook are available at www.

immunisation.dh.gov.uk

The advice in this chapter also incorporates changes

announced by the Chief Medical Officer and Health

Department Updates.



Cautions Most children can safely receive the

majority of vaccines. Vaccination may be postponed if

the child is suffering from an acute illness; however, it is

not necessary to postpone immunisation in children

with minor illnesses without fever or systemic upset.

See also Predisposition to Neurological Problems,

below. For individuals with bleeding disorders, see

Route of Administration, below. If alcohol or disinfectant is used for cleansing the skin it should be allowed to

evaporate before vaccination to prevent possible inactivation of live vaccines.

When 2 or more vaccines are required (and are not

available as a combined preparation), they should be

given simultaneously at different sites, preferably in a

different limb; if more than one injection is to be given in

the same limb, they should be administered at least

2.5 cm apart (but see also BCG Vaccines, p. 604). When

2 live vaccines cannot be given at the same time, they

should be separated by an interval of at least 4 weeks.

For interactions see Appendix I (vaccines).

See also Cautions under individual vaccines.



Contra-indications



Vaccines are contra-indicated

in children who have a confirmed anaphylactic reaction

to a preceding dose of a vaccine containing the same

antigens or vaccine component (such as antibacterials

in viral vaccines). The presence of the following excipients in vaccines and immunological products has

been noted under the relevant entries:

Gelatin

Gentamicin

Kanamycin

Neomycin

Penicillins



Polymyxin B

Streptomycin

Thiomersal



Hypersensitivity to egg Children with evidence of previous

anaphylactic reaction to egg should not be given tickborne encephalitis vaccine, and yellow fever vaccine

should only be considered under the guidance of a

specialist. Children with a history of egg allergy can

be immunised with either an egg-free influenza vaccine,

if available, or an influenza vaccine with an ovalbumin

content less than 120 nanograms/mL (facilities should

be available to treat anaphylaxis). If an influenza vaccine

containing ovalbumin is being considered in those with

a history of anaphylaxis to egg or egg allergy with

uncontrolled asthma, these children should be referred

to a specialist in hospital. See also Cautions under MMR

vaccine.

See also Vaccines and HIV infection, below.

Live vaccines may be contra-indicated temporarily in

children who are:

.



immunosuppressed

Response, below);



.



pregnant (see Pregnancy and Breast-feeding,

below).



(see



Impaired



Immune



See also Contra-indications under individual vaccines.



BNFC 2013–2014

Impaired immune response Immune response to

vaccines may be reduced in immunosuppressed

children and there is also a risk of generalised

infection

with

live

vaccines.

Severely

immunosuppressed children should not be given live

vaccines (including those with severe primary

immunodeficiency). Specialist advice should be sought

for children being treated with high doses of

corticosteroids (dose equivalents of prednisolone:

children, 2 mg/kg (or more than 40 mg) daily for at

least 1 week or 1 mg/kg daily for 1 month), or other

immunosuppressive drugs1, and for children with

malignant conditions undergoing chemotherapy or

generalised radiotherapy1,2. For special reference to

HIV infection, see below.

The Royal College of Paediatrics and Child Health has

produced a statement, Immunisation of the Immunocompromised Child (2002) (available at www.rcpch.ac.uk).



Pregnancy Live vaccines should not be administered routinely during pregnancy because of the theoretical risk of fetal infection but where there is a significant risk of exposure to disease (e.g. to yellow fever),

the need for vaccination usually outweighs any possible

risk to the fetus. Termination of pregnancy following

inadvertent immunisation is not recommended. There is

no evidence of risk from vaccinating pregnant women

with inactivated viral or bacterial vaccines or toxoids.

For use of specific vaccines during pregnancy, see

under individual vaccines.



Breast-feeding



Although there is a theoretical risk

of live vaccine being present in breast milk, vaccination

is not contra-indicated for women who are breast-feeding when there is significant risk of exposure to disease.

There is no evidence of risk from vaccinating women

who are breast-feeding, with inactivated viral or bacterial vaccines or toxoids. For use of specific vaccines

during breast-feeding, see under individual vaccines.



Side-effects



Oral vaccines, such as cholera, live poliomyelitis, rotavirus, and live typhoid, can also cause gastro-intestinal

disturbances such as nausea, vomiting, abdominal pain

and cramps, and diarrhoea.

See also Predisposition to Neurological Problems,

below.

1. Live vaccines should be postponed until at least 3

months after stopping high-dose systemic corticosteroids

and at least 6 months after stopping other immunosuppressive drugs or generalised radiotherapy (at least 12

months after discontinuing immunosuppressants following bone-marrow transplantation).

2. Use of normal immunoglobulin should be considered

after exposure to measles (see p. 624) and varicella–

zoster immunoglobulin considered after exposure to

chickenpox or herpes zoster (see p. 626).



601



Some vaccines (e.g. poliomyelitis) produce very few

reactions, while others (e.g. measles, mumps and rubella) may cause a very mild form of the disease.

Occasionally more serious adverse reactions can

occur—these should always be reported to the CHM

(see Adverse Reactions to Drugs, p. 11).

See also Preterm Birth, p. 602.



Predisposition to neurological problems

When there is a personal or family history of febrile

convulsions, there is an increased risk of these

occurring during fever from any cause including

immunisation, but this is not a contra-indication to

immunisation. In children who have had a seizure

associated with fever without neurological deterioration, immunisation is recommended; advice on the

management of fever (see Post-immunisation Pyrexia

in Infants, below) should be given before immunisation. When a child has had a convulsion not

associated with fever, and the neurological condition

is not deteriorating, immunisation is recommended.

Children with stable neurological disorders (e.g.

spina bifida, congenital brain abnormality, and

peri-natal hypoxic-ischaemic encephalopathy)

should be immunised according to the recommended schedule.

When there is a still evolving neurological problem,

including poorly controlled epilepsy, immunisation

should be deferred and the child referred to a specialist. Immunisation is recommended if a cause for

the neurological disorder is identified. If a cause is

not identified, immunisation should be deferred until

the condition is stable.



Post-immunisation pyrexia in infants

The parent should be advised that if pyrexia develops after childhood immunisation and the infant

seems distressed, a dose of paracetamol can be

given and, if necessary, a second dose can be

given 4–6 hours later. Ibuprofen can be used if

paracetamol is unsuitable, but if a second dose of

ibuprofen is required, it is given 6 hours after the first

dose. The parent should be warned to seek medical

advice if the pyrexia persists.

For post-immunisation pyrexia in an infant aged 2–3

months, the dose of paracetamol is 60 mg; the dose

of ibuprofen is 50 mg (on a doctor’s advice). An oral

syringe can be obtained from any pharmacy to give

the small volume required.

Further information on adverse effects associated with

specific vaccines can be found under individual vaccines.



Vaccines and HIV infection



HIV-positive children

with or without symptoms can receive the following live

vaccines:

MMR (but avoid if immunity significantly impaired),

varicella-zoster (but avoid if immunity significantly

impaired—consult product literature);2



and the following inactivated vaccines:

anthrax, cholera (oral), diphtheria, haemophilus

influenzae type b, hepatitis A, hepatitis B, human

papillomavirus, influenza (injection), meningo-



14 Immunological products and vaccines



Injection of a vaccine may be followed

by local reactions such as pain, inflammation, redness,

and lymphangitis. An induration or sterile abscess may

develop at the injection site. Gastro-intestinal disturbances, fever, headache, irritability, loss of appetite,

fatigue, myalgia, and malaise are among the most

commonly reported side-effects. Other side-effects

include influenza-like symptoms, dizziness, paraesthesia, asthenia, drowsiness, arthralgia, rash, and lymphadenopathy. Hypersensitivity reactions, such as bronchospasm, angioedema, urticaria, and anaphylaxis, are

very rare but can be fatal (see section 3.4.3 for management of allergic emergencies).



14.1 Active immunity



602



14.1 Active immunity



BNFC 2013–2014



Immunisation schedule

Vaccines for the childhood immunisation schedule should be obtained from local health organisations or from ImmForm

(www.immform.dh.gov.uk)—not to be prescribed on FP10 (HS21 in Northern Ireland; GP10 in Scotland; WP10 in Wales).



Preterm birth



14 Immunological products and vaccines



Babies born preterm should receive all routine immunisations based on their actual date of birth. The risk of

apnoea following vaccination is increased in preterm babies, particularly in those born at or before 28 weeks

postmenstrual age. If babies at risk of apnoea are in hospital at the time of their first immunisation, they should

be monitored for 48 hours after immunisation. If a baby develops apnoea, bradycardia, or desaturation after the

first immunisation, the second immunisation should also be given in hospital with similar monitoring.

Seroconversion may be unreliable in babies born earlier than 28 weeks’ gestation or in babies treated with

corticosteroids for chronic lung disease; consideration should be given to testing for antibodies against

Haemophilus influenzae type b, meningococcal C, and hepatitis B after primary immunisation.

When to immunise (for

preterm infants—see note

above)



Vaccine given and dose schedule (for details of dose, see under individual vaccines)



Neonates at risk only



. BCG Vaccine

See section 14.4, BCG Vaccines

. Hepatitis B Vaccine

See section 14.4, Hepatitis B Vaccine



2 months



. Diphtheria, Tetanus, Pertussis (Acellular, Component), Poliomyelitis (Inactivated), and

Haemophilus Type b Conjugate Vaccine (Adsorbed)

First dose

. Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed)

First dose



3 months



. Diphtheria, Tetanus, Pertussis (Acellular, Component), Poliomyelitis (Inactivated), and

Haemophilus Type b Conjugate Vaccine (Adsorbed)

Second dose

. Meningococcal Group C Conjugate Vaccine

First dose



4 months



. Diphtheria, Tetanus, Pertussis (Acellular, Component), Poliomyelitis (Inactivated), and

Haemophilus Type b Conjugate Vaccine (Adsorbed)

Third dose

. Meningococcal Group C Conjugate Vaccine

Second dose

. Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed)

Second dose



12 –13 months



. Measles, Mumps and Rubella Vaccine, Live (MMR)

First dose

. Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed)

Single booster dose

. Haemophilus Type b Conjugate Vaccine and Meningococcal Group C Conjugate Vaccine

Single booster dose



Between 3 years and

4 months, and 5 years



. Adsorbed Diphtheria [low dose], Tetanus, Pertussis (Acellular, Component) and

Poliomyelitis (Inactivated) Vaccine

or

Adsorbed Diphtheria, Tetanus, Pertussis (Acellular, Component) and Poliomyelitis

(Inactivated) Vaccine

Single booster dose

Note: Preferably allow interval of at least 3 years after completing primary course

. Measles, Mumps and Rubella Vaccine, Live (MMR)

Second dose



12–13 years (females only)



. Human Papillomavirus Vaccine

3 doses; second dose 1 month, and third dose 4–6 months after first dose1



13–18 years



. Adsorbed Diphtheria [low dose], Tetanus, and Poliomyelitis (Inactivated) Vaccine

Single booster dose



During adult life, women of

child-bearing age

susceptible to rubella



. Measles, Mumps and Rubella Vaccine, Live (MMR)

Women of child-bearing age who have not received 2 doses of a rubella-containing vaccine

or who do not have a positive antibody test for rubella should be offered rubella

immunisation (using the MMR vaccine)—exclude pregnancy before immunisation, but see

also section 14.4, Measles, Mumps and Rubella Vaccine



1. The two human papillomavirus vaccines are not interchangeable and one vaccine product should be used for the entire

course.



BNFC 2013–2014

coccal, pertussis, pneumococcal, poliomyelitis1, rabies,

tetanus, tick-borne encephalitis, typhoid (injection).

HIV-positive children should not receive:

BCG, influenza (nasal spray), typhoid (oral), yellow

fever2

Note The above advice differs from that for other

immunocompromised children; Immunisation of HIV-infected

Children issued by Children’s HIV Association (CHIVA) are

available at www.chiva.org.uk



Vaccines and asplenia



The following vaccines are

recommended for asplenic children or those with splenic dysfunction:

haemophilus influenzae type b; influenza; meningococcal A, C, W135, and Y conjugate; pneumococcal.



14.2 Passive immunity



603



with adequate levels of antibody to the disease for which

protection is sought (see under Immunoglobulins, section 14.5). 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 whenever

possible by the use of immunoglobulins. Reactions are

theoretically possible after injection of human immunoglobulins, but reports of such reactions are very rare.



For antibiotic prophylaxis in asplenia see p. 257.



Route of administration Vaccines should not be

given intravenously. Most vaccines are given by the

intramuscular route; some vaccines are given by other

routes—the intradermal route for BCG vaccine, deep

subcutaneous route for Japanese encephalitis and varicella vaccines, and the oral route for cholera, live poliomyelitis, rotavirus, and live typhoid vaccines. The intramuscular route should not be used in children with

bleeding disorders such as haemophilia or thrombocytopenia; vaccines usually given by the intramuscular

route should be given by deep subcutaneous injection

instead.

Note The Department of Health has advised against the use

of jet guns for vaccination owing to the risk of transmitting

blood-borne infections, such as HIV.



High-risk groups

For information on high-risk groups, see section 14.4

under individual vaccines

BCG Vaccines, p. 604



14.3



Storage and use



Care must be taken to store all vaccines and other

immunological products under the conditions recommended in the product literature, otherwise the preparation may become ineffective. Refrigerated storage is

usually necessary; many vaccines and immunoglobulins

need to be stored at 2–8˚C and not allowed to freeze.

Vaccines and immunoglobulins should be protected

from light. Reconstituted vaccines and opened multidose vials must be used within the period recommended

in the product literature. Unused vaccines should be

disposed of by incineration at a registered disposal

contractor.

Particular attention must be paid to instructions on the

use of diluents. Vaccines which are liquid suspensions

or are reconstituted before use should be adequately

mixed to ensure uniformity of the material to be

injected.



Hepatitis A Vaccine, p. 608

Hepatitis B Vaccine, p. 610

Influenza Vaccine, p. 612



14.4



Vaccines and antisera



Pneumococcal Vaccines, p. 617

Tetanus Vaccines, p. 620



Children with unknown or incomplete

immunisation history



For advice on the immunisation of children coming to

the UK, consult the handbook Immunisation against

Infectious Disease (2006) (available at www.dh.gov.uk)



14.2



Passive immunity



Immunity with immediate protection against certain

infective organisms can be obtained by injecting preparations made from the plasma of immune individuals

1. Inactivated poliomyelitis vaccine is now used instead of

oral poliomyelitis vaccine for routine immunisation of

children.

2. If yellow fever risk is unavoidable, specialist advice

should be sought.



Anthrax and yellow fever vaccines,

botulism antitoxin, diphtheria antitoxin, and snake and

spider venom antitoxins are available from local designated holding centres.

For antivenom, see Emergency Treatment of Poisoning,

p. 33.

Enquiries for vaccines not available commercially can

also be made to:

Immunisation and Countermeasures Response, Finance

and Accounting

Department of Health

Wellington House

133–155 Waterloo Road

London, SE1 8UG

vaccinesupply@PHE.gov.uk

In Scotland information about availability of vaccines

can be obtained from a Specialist in Pharmaceutical

Public Health.

In Wales enquiries for vaccines not commercially available should be directed to:

Welsh Medicines Information Centre

University Hospital of Wales

Cardiff, CF14 4XW

Tel: (029) 2074 2979



14 Immunological products and vaccines



For children born in the UK who present with an

inadequate or unknown immunisation history, investigation into immunisations received should be carried

out. Outstanding doses should be administered where

the routine childhood immunisation schedule has not

been completed.



Availability



604



14.4 Vaccines and antisera



In Northern Ireland:

Pharmacy and Medicines Management Centre

Beech House

Antrim Hospital Site

Northern Health and Social Care Trust

Bush Road

Antrim, BT41 2RL

rphps.admin@northerntrust.hscni.net

For further details of availability, see under individual

vaccines.



Anthrax vaccine

Anthrax vaccine is rarely required for children. For

further information see BNF section 14.4.



BCG vaccines

BCG (Bacillus Calmette-Gue´rin) is a live attenuated

strain derived from Mycobacterium bovis which stimulates the development of hypersensitivity to M. tuberculosis. BCG vaccine should be given intradermally by

operators skilled in the technique (see below).



14 Immunological products and vaccines



The expected reaction to successful BCG vaccination is

induration at the site of injection followed by a local

lesion which starts as a papule 2 or more weeks after

vaccination; the lesion may ulcerate then subside over

several weeks or months, leaving a small flat scar. A dry

dressing may be used if the ulcer discharges, but air

should not be excluded.

All children of 6 years and over being considered for

BCG immunisation must first be given a skin test for

hypersensitivity to tuberculoprotein (see under Diagnostic agents, below). A skin test is not necessary for

a child under 6 years, provided that the child has not

stayed for longer than 3 months in a country with an

incidence1 of tuberculosis greater than 40 per 100 000,

the child has not had contact with a person with tuberculosis, and there is no family history of tuberculosis

within the last 5 years.

BCG is recommended for the following groups of children if BCG immunisation has not previously been

carried out and they are negative for tuberculoprotein

hypersensitivity:

.



neonates with a family history of tuberculosis in the

last 5 years;



.



all neonates and infants (0–12 months) born in

areas where the incidence1 of tuberculosis is greater than 40 per 100 000;



.



neonates, infants, and children under 16 years with

a parent or grandparent born in a country with an

incidence1 of tuberculosis greater than 40 per

100 000;



.



new immigrants aged under 16 years who were

born in, or lived for more than 3 months in a

country with an incidence1 of tuberculosis greater

than 40 per 100 000;



.



new immigrants aged 16–18 years from Sub-Saharan Africa or a country1 with an incidence of tuberculosis greater than 500 per 100 000;



.



contacts of those with active respiratory tuberculosis;



1. List of countries or primary care trusts where the incidence of tuberculosis is greater than 40 cases per 100 000

is available at www.hpa.org.uk



BNFC 2013–2014

.



children under 16 years intending to live with local

people for more than 3 months in a country with an

incidence1 of tuberculosis greater than 40 per

100 000 (section 14.6).



BCG vaccine can be given simultaneously with another

live vaccine (see also section 14.1), but if they are not

given at the same time, an interval of 4 weeks should

normally be allowed between them. When BCG is given

to infants, there is no need to delay routine primary

immunisations. No further vaccination should be given

in the arm used for BCG vaccination for at least 3

months because of the risk of regional lymphadenitis.

For advice on chemoprophylaxis against tuberculosis,

see section 5.1.9; for treatment of infection following

vaccination, seek expert advice.



BACILLUS CALMETTE-GUE´RIN

VACCINE

BCG vaccine

Cautions see section 14.1; interactions: Appendix 1

(vaccines)

Contra-indications see section 14.1; also neonate in

household contact with known or suspected case of

active tuberculosis; generalised septic skin conditions

(for children with eczema, lesion-free site should be

used)

Pregnancy see p. 601

Breast-feeding see p. 601

Side-effects see section 14.1 and notes above; also at

the injection-site, subcutaneous abscess, prolonged

ulceration; rarely disseminated complications such as

osteitis or osteomyelitis

Indications and dose

Immunisation against tuberculosis

. By intradermal injection

Neonate 0.05 mL

Child 1 month–1 year 0.05 mL

Child 1–18 years 0.1 mL

Intradermal injection technique Skin is stretched between

thumb and forefinger and needle (size 25G or 26G) inserted

(bevel upwards) for about 3 mm into superficial layers of

dermis (almost parallel with surface). Needle should be short

with short bevel (can usually be seen through epidermis

during insertion). Tense raised blanched bleb showing tips of

hair follicles is sign of correct injection; 7 mm bleb : 0.1 mL

injection, 3 mm bleb : 0.05 mL injection; if considerable

resistance not felt, needle is too deep and should be removed

and reinserted before giving more vaccine.

To be injected at insertion of deltoid muscle onto humerus

(keloid formation more likely with sites higher on arm); tip of

shoulder should be avoided.



Intradermal

Bacillus Calmette-Gue´rin Vaccine A

BCG Vaccine, Dried/Tub/BCG

Injection, (powder for suspension), freeze-dried preparation of live bacteria of a strain derived from the

bacillus of Calmette and Gue´rin

Available from health organisations or from ImmForm (SSI

brand, multidose vial with diluent)



Diagnostic agents

The Mantoux test is recommended for tuberculin skin

testing, but no licensed preparation is currently available. Guidance for healthcare professionals is available

at www.dh.gov.uk/immunisation.



BNFC 2013–2014

In the Mantoux test, the diagnostic dose is administered

by intradermal injection of Tuberculin Purified Protein

Derivative (PPD).

The Heaf test (involving the use of multiple-puncture

apparatus) is no longer available.

Note Response to tuberculin may be suppressed by live viral

vaccines, viral infection, sarcoidosis, corticosteroid therapy,

or immunosuppression due to disease or treatment.

Tuberculin testing should not be carried out within 4 weeks

of receiving a live viral vaccine



Two interferon gamma release assay (IGRA) tests are

also available as an aid in the diagnosis of tuberculosis

infection: QuantiFERON®-TB Gold and T-SPOT ®.TB.

Both tests measure T-cell mediated immune response

to synthetic antigens. For further information on the use

of interferon gamma release assay tests for tuberculosis,

see www.hpa.org.uk.



Tuberculin Purified Protein Derivative A

(Tuberculin PPD)

Injection, heat-treated products of growth and lysis

of appropriate Mycobacterium spp. 20 units/mL

(2 units/0.1-mL dose) (for routine use), 1.5-mL vial;

100 units/mL (10 units/0.1-mL dose), 1.5-mL vial

Dose



Mantoux test

. By intradermal injection

2 units (0.1 mL of 20 units/mL strength) for routine

Mantoux test; if first test is negative and a further test is

considered appropriate 10 units (0.1 mL of 100 units/mL

strength)

Available from ImmForm (SSI brand)

Important The strength of tuberculin PPD in this product

may be different to the strengths of products used previously

for the Mantoux test; care is required to select the correct

strength



Botulism antitoxin

A polyvalent botulism antitoxin is available for the postexposure prophylaxis of botulism and for the treatment

of children thought to be suffering from botulism. It

specifically neutralises the toxins produced by Clostridium botulinum types A, B, and E. It is not effective

against infantile botulism as the toxin (type A) is seldom,

if ever, found in the blood in this type of infection.



Botulism Antitoxin A

A preparation containing the specific antitoxic globulins that have the power of neutralising the toxins

formed by types A, B, and E of Clostridium botulinum.

Note The BP title Botulinum Antitoxin is not used because

the preparation currently in use may have a different

specification

Dose



Prophylaxis

Consult product literature

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 from the local blood bank



605



Cholera vaccine

Cholera vaccine (oral) contains inactivated Inaba

(including El-Tor biotype) and Ogawa strains of Vibrio

cholerae, serotype O1 together with recombinant Bsubunit of the cholera toxin produced in Inaba strains

of V.cholerae, serotype O1.

Oral cholera vaccine is licensed for travellers to endemic or epidemic areas on the basis of current recommendations (see also section 14.6). Immunisation

should be completed at least 1 week before potential

exposure. However, there is no requirement for cholera

vaccination for international travel.

Immunisation with cholera vaccine does not provide

complete protection and all travellers to a country

where cholera exists should be warned that scrupulous

attention to food, water, and personal hygiene is essential.

Injectable cholera vaccine provides unreliable protection

and is no longer available in the UK.



CHOLERA VACCINE

Cautions see section 14.1 and notes above

Contra-indications see section 14.1; also acute gastro-intestinal illness

Pregnancy see p. 601

Breast-feeding see p. 601

Side-effects see section 14.1; also rarely respiratory

symptoms such as rhinitis and cough; very rarely sore

throat, insomnia

Indications and dose

See notes above

. By mouth

Child 2–6 years 3 doses each separated by an

interval of 1–6 weeks

Child 6–18 years 2 doses separated by an interval

of 1–6 weeks

Note If more than 6 weeks have elapsed between doses,

the primary course should be restarted



A single booster dose can be given 2 years after

primary course for children 6–18 years, and 6

months after primary course for children 2–6 years.

If more than 2 years have elapsed since the last

vaccination, the primary course should be repeated



Administration Dissolve effervescent sodium bicarbonate granules in a glassful of water (approximately

150 mL). For child over 6 years, add vaccine suspension to make one dose. For child 2–6 years,

discard half (approximately 75 mL) of the solution,

then add vaccine suspension to make one dose. Drink

within 2 hours. Food, drink and other oral medicines

should be avoided for 1 hour before and after

vaccination

Dukoral® (Crucell) A

Oral suspension, for dilution with solution of effervescent sodium bicarbonate granules, heat- and

formaldehyde-inactivated Inaba (including El-Tor

biotype) and Ogawa strains of Vibrio cholerae bacteria and recombinant cholera toxin B-subunit produced in V. cholerae, net price 2-dose pack =

£23.42. Counselling, administration



Diphtheria Vaccines

Diphtheria vaccines are prepared from the toxin of

Corynebacterium diphtheriae and adsorption on aluminium hydroxide or aluminium phosphate improves anti-



14 Immunological products and vaccines



Hypersensitivity reactions are a problem. 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. asthma, hay fever, etc. All children should be

tested for sensitivity (diluting the antitoxin if history of

allergy).



14.4 Vaccines and antisera



14 Immunological products and vaccines



606



14.4 Vaccines and antisera



genicity. The vaccine stimulates the production of the

protective antitoxin. The quantity of diphtheria toxoid in

a preparation determines whether the vaccine is defined

as ‘high dose’ or ‘low dose’. Vaccines containing the

higher dose of diphtheria toxoid are used for primary

immunisation of children under 10 years of age. Vaccines containing the lower dose of diphtheria toxoid are

used for primary immunisation in children over 10

years. Single-antigen diphtheria vaccine is not available

and adsorbed diphtheria vaccine is given as a combination product containing other vaccines.

For primary immunisation of children aged between 2

months and 10 years vaccination is recommended usually in the form of 3 doses (separated by 1-month intervals) of diphtheria, tetanus, pertussis (acellular, component),

poliomyelitis

(inactivated)

and

haemophilus type b conjugate vaccine (adsorbed)

(see Immunisation schedule, section 14.1). In unimmunised children aged over 10 years the primary course

comprises of 3 doses of adsorbed diphtheria [low

dose], tetanus and poliomyelitis (inactivated)

vaccine.

A booster dose should be given 3 years after the primary

course (this interval can be reduced to a minimum of 1

year if the primary course was delayed). Children under

10 years should receive either adsorbed diphtheria,

tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine or adsorbed diphtheria

[low dose], tetanus, pertussis (acellular, component)

and poliomyelitis (inactivated) vaccine. Children

aged over 10 years should receive adsorbed diphtheria

[low dose], tetanus, and poliomyelitis (inactivated)

vaccine.

A second booster dose, of adsorbed diphtheria [low

dose], tetanus and poliomyelitis (inactivated) vaccine,

should be given 10 years after the previous booster dose

(this interval can be reduced to a minimum of 5 years if

previous doses were delayed). For children who have

been vaccinated following a tetanus-prone wound, see

Tetanus vaccines, p. 620.



Travel



Children travelling to areas with a risk of

diphtheria infection should be fully immunised according to the UK schedule (see also section 14.6). If more

than 10 years have lapsed since completion of the UK

schedule, a dose of adsorbed diphtheria [low dose],

tetanus and poliomyelitis (inactivated) vaccine

should be administered.



Contacts



Advice on the management of cases of

diphtheria, carriers, contacts and outbreaks must be

sought from health protection units. The immunisation

history of infected children and their contacts should be

determined; those who have been incompletely immunised should complete their immunisation and fully

immunised individuals should receive a reinforcing

dose. For advice on antibacterial treatment to prevent

a secondary case of diphtheria in a non-immune child,

see Table 2, section 5.1.



DIPHTHERIA-CONTAINING

VACCINES

Cautions see section 14.1; see also individual components of vaccines

Contra-indications see section 14.1; see also individual components of vaccines

Pregnancy see p. 601

Breast-feeding see p. 601



BNFC 2013–2014

Side-effects see section 14.1; also restlessness, sleep

disturbances, and unusual crying in infants;

Licensed use Infanrix-IPV + Hib ® not licensed for use

in children over 36 months; Pediacel ® not licensed in

children over 4 years but Department of Health

recommends that these be used for children up to 10

years

Indications and dose

See notes above and under preparations

Diphtheria-containing vaccines for children

under 10 years

Important For children aged 10 years or over see

Diphtheria-containing Vaccines for Children Over 10 Years,

p. 607, and see Diphtheria-containing Vaccines for

Immunisation of Pregnant Women Against Pertussis, p. 607



Diphtheria, Tetanus, Pertussis (Acellular,

Component), Poliomyelitis (Inactivated) and

Haemophilus Type b Conjugate Vaccine

(Adsorbed) A

Injection, suspension of diphtheria toxoid, tetanus

toxoid, acellular pertussis, inactivated poliomyelitis

and Haemophilus influenzae type b (conjugated to

tetanus protein), net price 0.5-mL prefilled syringe =

£32.00

Excipients may include neomycin, polymyxin B and

streptomycin

Dose



Primary immunisation

. By intramuscular injection

Child 2 months–10 years 3 doses each of 0.5 mL separated by intervals of 1 month; see also notes on booster

doses, above

Available as part of childhood immunisation schedule,

from health organisations or ImmForm

Brands include Pediacel ®



Adsorbed Diphtheria, Tetanus, Pertussis

(Acellular, Component) and Poliomyelitis

(Inactivated) Vaccine A

Injection, suspension of diphtheria toxoid, tetanus

toxoid, acellular pertussis and inactivated poliomyelitis vaccine components adsorbed on a mineral carrier, net price 0.5-mL prefilled syringe = £17.56

Excipients may include neomycin and polymyxin B

Dose

First booster dose

. By intramuscular injection

Child 3–10 years 0.5 mL 3 years after primary immunisation; see also notes on booster doses, above

Available as part of childhood immunisation schedule,

from health organisations or ImmForm

Brands include Infanrix-IPV ®



Adsorbed Diphtheria [low dose], Tetanus,

Pertussis (Acellular, Component) and

Poliomyelitis (Inactivated) Vaccine A

Injection, suspension of diphtheria toxoid [low

dose], tetanus toxoid, acellular pertussis and inactivated poliomyelitis vaccine components adsorbed

on a mineral carrier, net price 0.5-mL prefilled

syringe = £11.98

Excipients may include neomycin, polymyxin B and

streptomycin

Dose

First booster dose



. By intramuscular injection

Child 3–10 years 0.5 mL 3 years after primary immunisation; see also notes on booster doses, above

Available as part of childhood immunisation schedule from

health organisations or ImmForm

Brands include Repevax ®



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