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PKU orange cooler 10 liquid (Vitaflo International Ltd)

87 ml (ACBS) . NHS indicative price = £5.01

PKU purple cooler 10 liquid (Vitaflo International Ltd)

87 ml (ACBS) . NHS indicative price = £5.01

PKU red cooler 10 liquid (Vitaflo International Ltd)

87 ml (ACBS) . NHS indicative price = £5.01

PKU white cooler 10 liquid (Vitaflo International Ltd)

87 ml (ACBS) . NHS indicative price = £5.01

PKU yellow cooler 10 liquid (Vitaflo International Ltd)

87 ml (ACBS) . NHS indicative price = £5.01

PKU cooler15 ®

▶ Nutritional supplement for the dietary management of

phenylketonuria in children over 3 years.

LIQUID, protein equivalent (essential and non-essential amino

acids except phenylalanine) 15 g, carbohydrate 7 g, energy

386 kJ (92 kcal)/130-mL pouch, with vitamins, minerals, and

trace elements.

PKU orange cooler 15 liquid (Vitaflo International Ltd)

130 ml (ACBS) . NHS indicative price = £7.46

PKU purple cooler 15 liquid (Vitaflo International Ltd)

130 ml (ACBS) . NHS indicative price = £7.46

PKU red cooler 15 liquid (Vitaflo International Ltd)

130 ml (ACBS) . NHS indicative price = £7.46

PKU white cooler 15 liquid (Vitaflo International Ltd)

130 ml (ACBS) . NHS indicative price = £7.46

PKU yellow cooler 15 liquid (Vitaflo International Ltd)

130 ml (ACBS) . NHS indicative price = £7.46

PKU cooler20 ®

▶ Nutritional supplement for the dietary management of

phenylketonuria in children over 3 years.

LIQUID, protein equivalent (essential and non-essential amino

acids except phenylalanine) 20 g, carbohydrate 9.4 g, energy

517 kJ (124 kcal)/174-mL pouch, with vitamins, minerals, and

trace elements.

PKU orange cooler 20 liquid (Vitaflo International Ltd)

174 ml (ACBS) . NHS indicative price = £10.02

PKU purple cooler 20 liquid (Vitaflo International Ltd)

174 ml (ACBS) . NHS indicative price = £10.02

PKU red cooler 20 liquid (Vitaflo International Ltd)

174 ml (ACBS) . NHS indicative price = £10.02

PKU white cooler 20 liquid (Vitaflo International Ltd)

174 ml (ACBS) . NHS indicative price = £10.02

PKU yellow cooler 20 liquid (Vitaflo International Ltd)

174 ml (ACBS) . NHS indicative price = £10.02

PKU express15 ®

▶ Nutritional supplement for the dietary management of

phenylketonuria. Not recommended for children under 3 years.

POWDER, protein equivalent (essential and non-essential amino

acids except phenylalanine) 15 g, carbohydrate 3.4 g, energy

310 kJ (74 kcal)/25 g, with vitamins, minerals, and trace

elements. To flavour unflavoured products, see FlavourPac

p. 1575.

PKU express 15 powder 25g sachets lemon (Vitaflo International Ltd)

30 sachet (ACBS) . NHS indicative price = £219.69

PKU express 15 powder 25g sachets orange (Vitaflo International Ltd)

30 sachet (ACBS) . NHS indicative price = £219.69

PKU express 15 powder 25g sachets tropical (Vitaflo International

Ltd)

30 sachet (ACBS) . NHS indicative price = £219.69

PKU express 15 powder 25g sachets unflavoured (Vitaflo

International Ltd)

30 sachet (ACBS) . NHS indicative price = £219.69

PKU express20 ®

▶ Nutritional supplement for the dietary management of

phenylketonuria. Not recommended for children under 3 years.

POWDER, protein equivalent (essential and non-essential amino

acids except phenylalanine) 20 g, carbohydrate 4.7 g, energy

422 kJ (101 kcal)/34 g, with vitamins, minerals, and trace

elements. To flavour unflavoured products, see FlavourPac

p. 1575.

PKU express 20 powder 34g sachets lemon (Vitaflo International Ltd)

30 sachet (ACBS) . NHS indicative price = £283.83

PKU express 20 powder 34g sachets orange (Vitaflo International

Ltd)

30 sachet (ACBS) . NHS indicative price = £283.83

BNF 78 Nutritional supplements for metabolic diseases 1585

Borderline substances | Appendix 2

A2

PKU express 20 powder 34g sachets tropical (Vitaflo International

Ltd)

30 sachet (ACBS) . NHS indicative price = £283.83

PKU express 20 powder 34g sachets unflavoured (Vitaflo

International Ltd)

30 sachet (ACBS) . NHS indicative price = £283.83

PKU gel ®

▶ For use as part of the low-protein dietary management of

phenylketonuria in children 6 months–10 years (unflavoured),

1–10 years (flavoured).

POWDER, protein equivalent (essential and non-essential amino

acids except phenylalanine) 10 g, carbohydrate 10.3 g

(unflavoured)/8.9 g (flavoured), fat less than 100 mg, energy

346 kJ (81 kcal) (unflavoured)/322 kJ (76 kcal) (flavoured)/24 g,

with vitamins, minerals, and trace elements. PKU Orange

contains soya. To flavour unflavoured products, see FlavourPac

p. 1575.

PKU gel powder 24g sachets unflavoured (Vitaflo International Ltd)

30 sachet (ACBS) . NHS indicative price = £151.98

PKU gel powder 24g sachets orange (Vitaflo International Ltd)

30 sachet (ACBS) . NHS indicative price = £151.98

PKU gel powder 24g sachets raspberry (Vitaflo International Ltd)

30 sachet (ACBS) . NHS indicative price = £151.98

PKU Lophlex ® LQ 10

▶ Nutritional supplement for the dietary management of

phenylketonuria in children over 4 years and adults including

pregnant women.

LIQUID, protein equivalent (essential and non-essential amino

acids except phenylalanine) 10 g, carbohydrate 4.4 g, fibre

250 mg, energy 245 kJ (58 kcal)/62.5 mL, with vitamins,

minerals, and trace elements.

PKU Lophlex LQ 10 liquid berry (Nutricia Ltd)

62.5 ml (ACBS) . NHS indicative price = £5.61

PKU Lophlex LQ 10 liquid juicy berries (Nutricia Ltd)

62.5 ml (ACBS) . NHS indicative price = £5.61

PKU Lophlex LQ 10 liquid juicy citrus (Nutricia Ltd)

62.5 ml (ACBS) . NHS indicative price = £5.61

PKU Lophlex LQ 10 liquid juicy orange (Nutricia Ltd)

62.5 ml (ACBS) . NHS indicative price = £5.61

PKU Lophlex LQ 10 liquid juicy tropical (Nutricia Ltd)

62.5 ml (ACBS) . NHS indicative price = £5.61

PKU Lophlex ® LQ 20

▶ Nutritional supplement for the dietary management of

phenylketonuria in children over 4 years and adults including

pregnant women.

LIQUID, protein equivalent (essential and non-essential amino

acids except phenylalanine) 20 g, carbohydrate 8.8 g, fibre

500 mg, energy 490 kJ (115 kcal)/125 mL, with vitamins,

minerals, and trace elements.

PKU Lophlex LQ 20 liquid berry (Nutricia Ltd)

125 ml (ACBS) . NHS indicative price = £11.19

PKU Lophlex LQ 20 liquid juicy berries (Nutricia Ltd)

125 ml (ACBS) . NHS indicative price = £11.19

PKU Lophlex LQ 20 liquid juicy citrus (Nutricia Ltd)

125 ml (ACBS) . NHS indicative price = £11.19

PKU Lophlex LQ 20 liquid juicy orange (Nutricia Ltd)

125 ml (ACBS) . NHS indicative price = £11.19

PKU Lophlex LQ 20 liquid juicy tropical (Nutricia Ltd)

125 ml (ACBS) . NHS indicative price = £11.19

PKU Lophlex LQ 20 liquid orange (Nutricia Ltd)

125 ml (ACBS) . NHS indicative price = £11.19

PKU Lophlex ® Sensation 20

▶ Nutritional supplement for the dietary management of

phenylketonuria in children over 4 years and adults including

pregnant women.

SEMI-SOLID, protein equivalent (containing essential and nonessential amino acids except phenylalanine) 20 g, carbohydrate

20.2 g, fibre 1 g, energy 706 kJ (166 kcal)/109 g, with vitamins,

minerals, and trace elements.

PKU Lophlex Sensation 20 berries (Nutricia Ltd)

327 gram (ACBS) . NHS indicative price = £35.76

XP Maxamum ®

▶ Nutritional supplement for the dietary management of

phenylketonuria in children over 8 years and adults.

POWDER, protein equivalent (essential and non-essential amino

acids except phenylalanine) 39 g, carbohydrate 34 g, fat less

than 500 mg, energy 1260 kJ (297 kcal)/100 g, with vitamins,

minerals, and trace elements. To flavour unflavoured products,

see Modjul Flavour System p. 1576.

PKU Maxamum oral powder 50g sachets orange (Nutricia Ltd)

30 sachet (ACBS) . NHS indicative price = £292.20

PKU Maxamum oral powder 50g sachets unflavoured (Nutricia Ltd)

30 sachet (ACBS) . NHS indicative price = £292.20

PKU Maxamum powder orange (Nutricia Ltd)

500 gram (ACBS) . NHS indicative price = £97.44

PKU Maxamum powder unflavoured (Nutricia Ltd)

500 gram (ACBS) . NHS indicative price = £97.44

Tyrosinaemia

Methionine-free TYR Anamix ® Infant

▶ Nutritional supplement for the dietary management of proven

tyrosinaemia type 1 in children from birth to 3 years.

POWDER, protein equivalent (essential and non-essential amino

acids except methionine, phenylalanine, and tyrosine) 13.1 g,

carbohydrate 49.5 g, fat 23 g, fibre 5.3 g, energy 1915 kJ

(457 kcal)/100 g, with vitamins, minerals, and trace elements;

standard dilution (15%) provides protein equivalent 2 g,

carbohydrate 7.4 g, fat 3.5 g, fibre 800 mg, energy 287 kJ

(69 kcal)/100 mL.

TYR Anamix Infant methionine free powder (Nutricia Ltd)

400 gram (ACBS) . NHS indicative price = £42.17

TYR Anamix ® Infant

▶ Nutritional supplement for the dietary management of proven

tyrosinaemia where plasma-methionine concentrations are

normal in children from birth to 3 years.

POWDER, protein equivalent (essential and non-essential amino

acids except phenylalanine and tyrosine) 13.1 g, carbohydrate

49.5 g, fat 23 g, fibre 5.3 g, energy 1915 kJ (457 kcal)/100 g, with

vitamins, minerals, and trace elements; standard dilution (15%)

provides protein equivalent 2 g, carbohydrate 7.4 g, fat 3.5 g,

fibre 800 mg, energy 287 kJ (69 kcal)/100 mL.

TYR Anamix Infant methionine free powder (Nutricia Ltd)

400 gram (ACBS) . NHS indicative price = £42.17

TYR Anamix Infant powder (Nutricia Ltd)

400 gram (ACBS) . NHS indicative price = £42.17

TYR Anamix ® Junior

▶ Nutritional supplement for the dietary management of proven

tyrosinaemia in children 1–10 years.

POWDER, protein equivalent (essential and non-essential amino

acids except phenylalanine and tyrosine) 8.4 g, carbohydrate

11 g, fat 3.9 g, energy 475 kJ (113 kcal)/29-g sachet, with

vitamins, minerals, and trace elements.

TYR Anamix Junior oral powder 29g sachets (Nutricia Ltd)

30 sachet (ACBS) . NHS indicative price = £206.40

TYR Anamix ® Junior LQ

▶ Nutritional supplement for the dietary management of

tyrosinaemia type 1 (when nitisinone (NTBC) is used, see

nitisinone p. 1067), type II, and type III, in children over 1 year.

LIQUID, protein equivalent (essential and non-essential amino

acids except phenylalanine and tyrosine) 10 g,carbohydrate

8.8 g, fat 4.8 g, fibre 310 mg, energy 500 kJ (119 kcal)/125 mL,

with vitamins, minerals and trace elements.

TYR Anamix Junior LQ liquid (Nutricia Ltd)

125 ml (ACBS) . NHS indicative price = £9.78

TYR cooler ® 15

▶ Nutritional supplement for the dietary management of

tyrosinaemia in children over 3 years and adults.

LIQUID, protein equivalent (essential and non-essential amino

acids except tyrosine and phenylalanine) 15 g, carbohydrate 7 g,

1586 Nutritional supplements for metabolic diseases BNF 78

Borderline substances | Appendix 2

A2

fat 500 mg, energy 393 kJ (92 kcal)/130 mL, with vitamins,

minerals, and trace elements.

TYR orange cooler 15 liquid (Vitaflo International Ltd)

130 ml (ACBS) . NHS indicative price = £12.31

TYR red cooler 10 liquid (Vitaflo International Ltd)

87 ml (ACBS) . NHS indicative price = £7.60

TYR red cooler 15 liquid (Vitaflo International Ltd)

130 ml (ACBS) . NHS indicative price = £12.31

TYR red cooler 20 liquid (Vitaflo International Ltd)

174 ml (ACBS) . NHS indicative price = £15.89

TYR express15 ®

▶ Nutritional supplement for the dietary management of

tyrosinaemia in children over 8 years and adults.

POWDER, protein equivalent (essential and non-essential amino

acids except tyrosine and phenylalanine) 15 g, carbohydrate

3.4 g, fat less than 100 mg, energy 310 kJ (74 kcal)/25 g, with

vitamins, minerals, and trace elements. To flavour unflavoured

products, see FlavourPac p. 1575.

TYR express 15 oral powder 25g sachets (Vitaflo International Ltd)

30 sachet (ACBS) . NHS indicative price = £362.37

TYR express20 ®

▶ Nutritional supplement for the dietary management of

tyrosinaemia in children over 8 years.

POWDER, protein equivalent (essential and non-essential amino

acids except tyrosine and phenylalanine) 20 g, carbohydrate

4.7 g, fat less than 100 mg, energy 416 kJ (99 kcal)/34 g, with

vitamins, minerals, and trace elements. To flavour unflavoured

products, see FlavourPac p. 1575.

TYR express 20 oral powder 34g sachets (Vitaflo International Ltd)

30 sachet (ACBS) . NHS indicative price = £468.17

TYR Gel ®

▶ Nutritional supplement for the dietary management of

tyrosinaemia in children 1–10 years.

GEL, protein equivalent (essential and non-essential amino

acids except tyrosine and phenylalanine) 10 g, carbohydrate

10.3 g, fat less than 100 mg, energy 339 kJ (81 kcal)/24 g, with

vitamins, minerals and trace elements. To flavour unflavoured

products, see FlavourPac p. 1575.

TYR gel oral powder 24g sachets (Vitaflo International Ltd)

30 sachet (ACBS) . NHS indicative price = £233.29

TYR Lophlex ® LQ 20

▶ Nutritional supplement for the dietary management of

tyrosinaemia in children over 4 years and adults, including

pregnant women (in conjunction with standard folic acid

supplementation).

LIQUID, protein equivalent (essential and non-essential amino

acids except phenylalanine and tyrosine) 20 g, carbohydrate

8.8 g, fat less than 500 mg, fibre 500 mg, energy 509 kJ

(120 kcal)/125 mL, with vitamins, minerals, and trace elements.

TYR Lophlex LQ 20 liquid (Nutricia Ltd)

125 ml (ACBS) . NHS indicative price = £17.39

XPHEN TYR Tyrosidon ®

▶ Nutritional supplement for the management of tyrosinaemia in

children and adults where plasma-methionine concentrations

are normal.

POWDER, protein equivalent (essential and non-essential amino

acids except phenylalanine and tyrosine) 77 g, carbohydrate

4.5 g, fat nil, energy 1386 kJ (326 kcal)/100 g. To flavour

unflavoured products, see Modjul Flavour System p. 1576.

XPHEN TYR Tyrosidon Free AA Mix powder (Nutricia Ltd)

500 gram (ACBS) . NHS indicative price = £201.74

XPTM Tyrosidon ®

▶ Nutritional supplement for the dietary management of

tyrosinaemia type I in children and adults where plasmamethionine concentrations are above normal.

POWDER, protein equivalent (essential and non-essential amino

acids except methionine, phenylalanine, and tyrosine) 77 g,

carbohydrate 4.5 g, fat nil, energy 1386 kJ (326 kcal)/100 g. To

flavour unflavoured products, see Modjul Flavour System

p. 1576.

XPTM Tyrosidon powder (Nutricia Ltd)

500 gram . NHS indicative price = £91.31

BNF 78 Nutritional supplements for metabolic diseases 1587

Borderline substances | Appendix 2

A2

Appendix 3

Cautionary and advisory labels

for dispensed medicines

Guidance for cautionary and advisory labels

Medicinal forms within BNF publications include code numbers

of the cautionary labels that pharmacists are recommended to

add when dispensing. It is also expected that pharmacists will

counsel patients and carers when necessary.

Counselling needs to be related to the age, experience,

background, and understanding of the individual patient or

carer. The pharmacist should ensure understanding of how to

take or use the medicine and how to follow the correct dosage

schedule. Any effects of the medicine on co-ordination,

performance of skilled tasks (e.g. driving or work), any foods or

medicines to be avoided, and what to do if a dose is missed

should also be explained. Other matters, such as the possibility

of staining of the clothes or skin, or discolouration of urine or

stools by a medicine should also be mentioned.

For some medicines there is a special need for counselling,

such as an unusual method or time of administration or a

potential interaction with a common food or domestic remedy,

and this should be mentioned where necessary.

Original packs

Most preparations are dispensed in unbroken original packs

that include further advice for the patient in the form of patient

information leaflets. Label 10 may be of value where

appropriate. More general leaflets advising on the

administration of preparations such as eye drops, eye

ointments, inhalers, and suppositories are also available.

Scope of labels

In general no label recommendations have been made for

injections on the assumption that they will be administered by a

healthcare professional or a well-instructed patient. The

labelling is not exhaustive and pharmacists are recommended

to use their professional discretion in labelling new

preparations and those for which no labels are shown.

Individual labelling advice is not given on the administration

of the large variety of antacids. In the absence of instructions

from the prescriber, and if on enquiry the patient has had no

verbal instructions, the directions given under ‘Dose’ should be

used on the label.

It is recognised that there may be occasions when pharmacists

will use their knowledge and professional discretion and decide

to omit one or more of the recommended labels for a particular

patient. In this case counselling is of the utmost importance.

There may also be an occasion when a prescriber does not wish

additional cautionary labels to be used, in which case the

prescription should be endorsed ‘NCL’ (no cautionary labels).

The exact wording that is required instead should then be

specified on the prescription.

Pharmacists label medicines with various wordings in

addition to those directions specified on the prescription. Such

labels include ‘Shake the bottle’, ‘For external use only’, and

‘Store in a cool place’, as well as ‘Discard.... days after opening’

and ‘Do not use after....’, which apply particularly to antibiotic

mixtures, diluted liquid and topical preparations, and to eyedrops. Although not listed in the BNF these labels should

continue to be used when appropriate; indeed, ‘For external use

only’ is a legal requirement on external liquid preparations,

while ‘Keep out of the reach of children’ is a legal requirement

on all dispensed medicines. Care should be taken not to obscure

other relevant information with adhesive labelling.

It is the usual practice for patients to take standard tablets

with water or other liquid and for this reason no separate label

has been recommended.

The label wordings recommended by the BNF apply to

medicines dispensed against a prescription. Patients should be

aware that a dispensed medicine should never be taken by, or

shared with, anyone other than for whom the prescriber

intended it. Therefore, the BNF does not include warnings

against the use of a dispensed medicine by persons other than

for whom it was specifically prescribed.

The label or labels for each preparation are recommended

after careful consideration of the information available.

However, it is recognised that in some cases this information

may be either incomplete or open to a different interpretation.

The BNF will therefore be grateful to receive any constructive

comments on the labelling suggested for any preparation.

Recommended label wordings

For BNF 61 (March 2011), a revised set of cautionary and

advisory labels were introduced. All of the existing labels were

user-tested, and the revised wording selected reflects

terminology that is better understood by patients.

Wordings which can be given as separate warnings are labels

1–19, 29–30, and 32. Wordings which can be incorporated in an

appropriate position in the directions for dosage or

administration are labels 21–28. A label has been omitted for

number 20; labels 31 and 33 no longer apply to any medicines in

the BNF and have therefore been deleted.

If separate labels are used it is recommended that the

wordings be used without modification. If changes are made to

suit computer requirements, care should be taken to retain the

sense of the original.

Welsh labels

Comprehensive Welsh translations are available for each

cautionary and advisory label.

Labels

1 Warning: This medicine may make you sleepy

Rhybudd: Gall y feddyginiaeth hon eich gwneud yn gysglyd

To be used on preparations for children containing

antihistamines, or other preparations given to children

where the warnings of label 2 on driving or alcohol would

not be appropriate.

2 Warning: This medicine may make you sleepy. If this happens,

do not drive or use tools or machines. Do not drink alcohol

Rhybudd: Gall y feddyginiaeth hon eich gwneud yn gysglyd.

Peidiwch â gyrru, defnyddio offer llaw neu beiriannau os yw

hyn yn digwydd. Peidiwch ag yfed alcohol

To be used on preparations for adults that can cause

drowsiness, thereby affecting coordination and the ability to

drive and operate hazardous machinery; label 1 is more

appropriate for children. It is an offence to drive while under

the influence of drink or drugs.

Some of these preparations only cause drowsiness in the

first few days of treatment and some only cause drowsiness

in higher doses.

In such cases the patient should be told that the advice

applies until the effects have worn off. However many of

these preparations can produce a slowing of reaction time

and a loss of mental concentration that can have the same

effects as drowsiness.

Avoidance of alcoholic drink is recommended because the

effects of CNS depressants are enhanced by alcohol. Strict

prohibition however could lead to some patients not taking

the medicine. Pharmacists should therefore explain the risk

1588 Cautionary and advisory labels for dispensed medicines BNF 78

Cautionary and advisory labels | Appendix 3

A3

and encourage compliance, particularly in patients who may

think they already tolerate the effects of alcohol (see also

label 3). Queries from patients with epilepsy regarding

fitness to drive should be referred back to the patient’s

doctor.

Side-effects unrelated to drowsiness that may affect a

patient’s ability to drive or operate machinery safely include

blurred vision, dizziness, or nausea. In general, no label has

been recommended to cover these cases, but the patient

should be suitably counselled.

3 Warning: This medicine may make you sleepy. If this happens,

do not drive or use tools or machines

Rhybudd: Gall y feddyginiaeth hon eich gwneud yn gysglyd.

Peidiwch â gyrru, defnyddio offer llaw neu beiriannau os yw

hyn yn digwydd

To be used on preparations containing monoamine-oxidase

inhibitors; the warning to avoid alcohol and dealcoholised

(low alcohol) drink is covered by the patient information

leaflet.

Also to be used as for label 2 but where alcohol is not an

issue.

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