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ORAMORPH ORAL SOLUTION 10MG/5ML

Active substance: MORPHINE SULFATE

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Package Leaflet: Information for the User

Oramorph® Oral Solution
10 mg/5 ml

abcd

(morphine sulphate)
Read all of this leaflet carefully before you start taking this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• If any of the side effects gets troublesome or serious, or if you
notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What ORAMORPH Oral Solution is and what it is used for
2. Before you take ORAMORPH Oral Solution
3. How to take ORAMORPH Oral Solution
4. Possible side effects
5. How to store ORAMORPH Oral Solution
6. Further information
1. WHAT ORAMORPH ORAL SOLUTION IS AND WHAT IT IS
USED FOR
The name of your medicine is ORAMORPH Oral Solution
10 mg/5 ml (called ORAMORPH in this leaflet).
• It contains a medicine called morphine sulphate. This belongs
to a group of medicines called ‘opioid analgesics’
• It is used to relieve severe pain
2. BEFORE YOU TAKE ORAMORPH ORAL SOLUTION
Do not take ORAMORPH if:
• You are allergic (hypersensitive) to morphine sulphate or any of
the other ingredients of ORAMORPH (listed in Section 6 below)
• You have problems with your lungs or breathing such as
‘hypoventilation’ or ‘Chronic Obstructive Pulmonary Disorder’
(COPD)
• You are having an asthma attack
• You have sudden or recent liver problems
• You have recently had a head injury
• You have something called ‘phaeochromocytoma’. This is a rare
tumour which is not malignant
• You have fits (convulsions) or raised pressure inside your skull
• The person taking the medicine is in a deep and prolonged
unconscious state (coma)
• You are addicted to alcohol or have recently consumed large
amounts of alcohol
• You are taking or have in the last two weeks taken medication
to treat depression such as monoamine-oxidase inhibitors
(MAOI)
• You have paralytic ileus (loss of intestinal movement)
Do not take this medicine if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist.
Take special care with ORAMORPH
Check with your doctor or pharmacist before taking your
medicine if:
• You are pregnant, trying to become pregnant or if you are
breast-feeding
• You have had an operation within the last 24 hours
• You have a particular lung problem that causes shortness of
breath called emphysema
• You have shock (circulatory failure)
• You have asthma
• You have gall bladder problems
• You have long term (chronic) liver or kidney problems
• You are a man who has prostate problems
• You have an under-active thyroid gland or swelling of your skin
(myxoedema)
• Your spine is unusually curved (kyphoscoliosis)
• You have bowel problems
• You have an under-active adrenal gland (adrenocortical
insufficiency)
• You are very overweight
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking ORAMORPH.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines that
you buy without a prescription and herbal medicines. This is
because ORAMORPH can affect the way some other medicines
work. Also some other medicines can affect the way
ORAMORPH works.
In particular tell your doctor or pharmacist if you are taking any of
the following medicines:
• Medicines to help you sleep, make you feel less anxious or calm
you down such as tranquilisers, hypnotics, sedatives,
antipsychotics or tricyclic antidepressants
• Anaesthetics - used during operations
• Domperidone and metoclopramide – for feeling sick (nausea)
and being sick (vomiting)
• Mexiletine and esmolol - for controlling heart rhythm
• Ritonavir - for HIV infections
• Cimetidine - for stomach ulcers, indigestion or heartburn
• Monoamine oxidase inhibitors (MAOIs) - for depression
• Voriconazole - for some fungal infections
• Gabapentin - for epilepsy and long lasting pain caused by
damage to the nerves
Taking ORAMORPH with food and drink
You should avoid alcohol whilst taking this medicine.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are
pregnant, trying to become pregnant or if you are breast-feeding.
If you take this medicine during pregnancy or while breast-
feeding, it may slow down the baby’s breathing. If you take this
medicine for a long time whilst pregnant, it may mean that the
baby will be born showing signs of withdrawal.
Operations and anaesthetics
Tell your doctor or pharmacist if you are due to have an operation
or an anaesthetic or if you have had an operation or an
anaesthetic within the last 24 hours.
Driving and using machines
You may feel drowsy while taking this medicine. If this happens,
do not drive or use any tools or machines.
Important information about some of the ingredients of
ORAMORPH
This medicine contains:
• Ethanol (Alcohol): This product contains 10 volume % ethanol
(alcohol). Each dose contains up to 0.81 g of alcohol which is
equivalent to 20 ml beer or 8.3 ml wine. This medicine is harmful if
you are addicted to alcohol. The amount of alcohol should also be
considered if you are pregnant or breast-feeding, have long term
(chronic) liver problems or epilepsy, or you are a child
• Sucrose: This product contains 30 g of sucrose in the 100 ml
bottle, 90 g of sucrose in the 300 ml bottle, and 150 g of sucrose
in the 500 ml bottle. When taken according to the dosage
recommendations each dose supplies up to 3 g of sucrose. You
should not take this product if you have a bowel condition that
makes you intolerant to some sugars such as fructose, glucose,
galactose or sucrose
• Methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) - These may cause allergic
reactions in some people that could occur some time after
taking this medicine. The signs may include swelling of the
mouth and face, sudden breathing difficulties and your blood
pressure being lower than normal
3. HOW TO TAKE ORAMORPH ORAL SOLUTION
Always take this medicine exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
Taking this medicine
• Take this medicine by mouth
• Use a 5 ml plastic spoon to measure your dose
• They are available from your pharmacist
437737/GB/12

Mandatory in

File information

TD

PITCH CODE

Printfile

Issue date of TD:

25.05.2010

Yes

PPM SKU:

P004041

No

012

No

Yes

Issue date of artwork:

08.09.2010

No

Yes

Print colors:

PAN Black

No

2 mm

Yes

PPM SKU version: 

= 0,35 mm

Yes

Yes

= 1 mm

= 10 mm

Mat. No. Pack. Site:

437737-12

Legend case version:

V1.0 01/DEC/2009 (please do not change or remove it)

No

5 mm

1 mm

Yes
= 0,65 mm

Technical information

= 9 mm

= 46,5 mm

a = Batch No.

b = Expiry date

c = Manufacturing date

d = Price/Sample/Clinic

Technical colors
BI-Diecut-Legendcase

Free area

Additional Requirements of Packaging Site
Dimensions: mm 200 x 305 folded to 200 x 36mm

Gluepoints

= 2 mm

How much to take
Your doctor will decide the amount of medicine to give you.
Adults
• The usual dose is 5 to 10 ml (one to two teaspoons) every four
hours
Paediatric population

Children 13 to 18 years
• The most that should be taken is 2.5 to 10 ml (half to two
teaspoons) every four hours
Children 6 to 12 years
• The most that should be taken is 2.5 to 5 ml (half to one
teaspoon) every four hours
Children 1 to 5 years
• The most that should be taken is 2.5 ml (half a teaspoon)
every four hours
Children under 1 year
• Do not give this medicine to children under 1 year
Being given more or less of this medicine
• For some people, it may be necessary for the doctor to give a
higher dose
• For other people (for example the elderly, people with kidney or
liver problems and people that should not be sedated) the
doctor may decide to use a lower dose
Your body may get used to the medicine (tolerance)
• Do not take more than your doctor has prescribed
• If you have been taking your medicine for some time you may
find that it does not seem to be working as well as it did. If this
happens, talk to your doctor

Other side effects
• Feeling sick (nausea) or being sick (vomiting)
• Constipation, which can be treated with appropriate laxatives
• Difficulty in passing water (urine)
• Feeling drowsy
• Dry mouth, sweating and flushing of your face
• Your heart rate getting faster (tachycardia) or slower
(bradycardia) or fast and uneven (palpitations)
• Lower body temperature (hypothermia)
• Lowered sex drive
• Seeing or hearing things that are not there (hallucinations) or
feeling confused
• Muscles feeling tense
• The black circle in the centre of your eyes (pupil) getting smaller
(miosis)
• Dependence on ORAMORPH. This can happen with any
morphine product
If any of the side effects gets troublesome or serious, or if you
notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE ORAMORPH ORAL SOLUTION
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on
the bottle label and the outer carton. The expiry date refers to the
last day of the month.
Do not store ORAMORPH above 25°C.
Store in the original container in order to protect from light.
Please return any remaining medicine to your pharmacist
3 months after first opening.

If you take more ORAMORPH than you should
If you take more of this medicine than you should, talk to a
doctor or go to a hospital straight away. Take the medicine pack
with you. This is so the doctor knows what you have taken.

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect
the environment.

If you take more than you should, the following effects may
happen:
• The black circle in the centre of your eyes (pupil) gets smaller
• You breath more slowly
• You have low blood pressure

6. FURTHER INFORMATION

In more severe cases, very high doses could cause your blood
circulation to slow down and cause unconsciousness for a long
time, or even death. In children a high dose may cause fits
(convulsions).
If you forget to take ORAMORPH
• If you forget a dose, take it as soon as you remember it and take
your next dose at the usual time
• If it is nearly time for the next dose, skip the missed dose. This is
because the time between doses should be at least 4 hours
• Do not take a double dose to make up for a forgotten dose
If you stop taking ORAMORPH
It is important to talk to your doctor if you want to stop taking
your medicine. Do not stop taking your medicine suddenly. This is
because your body may have got used to it. Also, you may need to
have your dose lowered slowly.
4. POSSIBLE SIDE EFFECTS
Like all medicines, ORAMORPH can cause side effects, although
not everybody gets them. The following side effects may happen
with this medicine:
Allergic reactions
If you have a severe allergic reaction, stop taking this medicine
and see a doctor straight away. Signs may include swelling of the
mouth and face, difficulty breathing, dizziness and skin reactions
such as rash and itching.
Tell your doctor straight away if you notice the following side
effects. You may need urgent medical treatment:
• Having a headache. This could be a sign of raised pressure
inside your skull
• Feeling dizzy or unsteady when you stand up. This could be a
sign of a temporary fall in blood pressure (orthostatic
hypotension)
• Shallow breathing, with a slow heartbeat (bradycardia) and cold
clammy skin
• Feeling restless, irritable or having changes in your mood
• Stomach pain caused by spasm (cramps) of the tubes that carry
urine to the bladder or bile to the intestines

What ORAMORPH contains
• Each 5 ml contains 10 mg of morphine sulphate as the active
ingredient
• The other ingredients are alcohol (ethanol), corn syrup, sucrose,
methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216) and purified water
What ORAMORPH looks like and content of the pack
ORAMORPH is a solution and is available in bottles of 100, 250,
300 and 500 ml. The bottles come in cartons.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for ORAMORPH is held by:
Boehringer Ingelheim Limited,
Ellesfield Avenue,
Bracknell, Berkshire,
RG12 8YS, United Kingdom
and the solution is manufactured by:
Istituto de Angeli S.r.l. at:
Località Prulli Si Sotto n. 103/C
50066 Reggello (FI)
Italy
This leaflet was revised in June 2010.
© Boehringer Ingelheim Limited 2010

437737/GB/12

Package Leaflet: Information for the User

Oramorph® Oral Solution
10 mg/5 ml

abcd

(morphine sulphate)
Read all of this leaflet carefully before you start taking this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• If any of the side effects gets troublesome or serious, or if you
notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What ORAMORPH Oral Solution is and what it is used for
2. Before you take ORAMORPH Oral Solution
3. How to take ORAMORPH Oral Solution
4. Possible side effects
5. How to store ORAMORPH Oral Solution
6. Further information
1. WHAT ORAMORPH ORAL SOLUTION IS AND WHAT IT IS
USED FOR
The name of your medicine is ORAMORPH Oral Solution
10 mg/5 ml (called ORAMORPH in this leaflet).
• It contains a medicine called morphine sulphate. This belongs
to a group of medicines called ‘opioid analgesics’
• It is used to relieve severe pain
2. BEFORE YOU TAKE ORAMORPH ORAL SOLUTION
Do not take ORAMORPH if:
• You are allergic (hypersensitive) to morphine sulphate or any of
the other ingredients of ORAMORPH (listed in Section 6 below)
• You have problems with your lungs or breathing such as
‘hypoventilation’ or ‘Chronic Obstructive Pulmonary Disorder’
(COPD)
• You are having an asthma attack
• You have sudden or recent liver problems
• You have recently had a head injury
• You have something called ‘phaeochromocytoma’. This is a rare
tumour which is not malignant
• You have fits (convulsions) or raised pressure inside your skull
• The person taking the medicine is in a deep and prolonged
unconscious state (coma)
• You are addicted to alcohol or have recently consumed large
amounts of alcohol
• You are taking or have in the last two weeks taken medication
to treat depression such as monoamine-oxidase inhibitors
(MAOI)
• You have paralytic ileus (loss of intestinal movement)
Do not take this medicine if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist.
Take special care with ORAMORPH
Check with your doctor or pharmacist before taking your
medicine if:
• You are pregnant, trying to become pregnant or if you are
breast-feeding
• You have had an operation within the last 24 hours
• You have a particular lung problem that causes shortness of
breath called emphysema
• You have shock (circulatory failure)
• You have asthma
• You have gall bladder problems
• You have long term (chronic) liver or kidney problems
• You are a man who has prostate problems
• You have an under-active thyroid gland or swelling of your skin
(myxoedema)
• Your spine is unusually curved (kyphoscoliosis)
• You have bowel problems
• You have an under-active adrenal gland (adrenocortical
insufficiency)
• You are very overweight
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking ORAMORPH.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines that
you buy without a prescription and herbal medicines. This is
because ORAMORPH can affect the way some other medicines
work. Also some other medicines can affect the way
ORAMORPH works.
In particular tell your doctor or pharmacist if you are taking any of
the following medicines:
• Medicines to help you sleep, make you feel less anxious or calm
you down such as tranquilisers, hypnotics, sedatives,
antipsychotics or tricyclic antidepressants
• Anaesthetics - used during operations
• Domperidone and metoclopramide – for feeling sick (nausea)
and being sick (vomiting)
• Mexiletine and esmolol – for controlling heart rhythm
• Ritonavir – for HIV infections
• Cimetidine – for stomach ulcers, indigestion or heartburn
• Monoamine oxidase inhibitors (MAOIs) - for depression
• Voriconazole - for some fungal infections
• Gabapentin - for epilepsy and long lasting pain caused by
damage to the nerves
Taking ORAMORPH with food and drink
You should avoid alcohol whilst taking this medicine.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are
pregnant, trying to become pregnant or if you are breast-feeding.
If you take this medicine during pregnancy or while breast-
feeding, it may slow down the baby’s breathing. If you take this
medicine for a long time whilst pregnant, it may mean that the
baby will be born showing signs of withdrawal.
Operations and anaesthetics
Tell your doctor or pharmacist if you are due to have an operation
or an anaesthetic or if you have had an operation or an
anaesthetic within the last 24 hours.
Driving and using machines
You may feel drowsy while taking this medicine. If this happens,
do not drive or use any tools or machines.
Important information about some of the ingredients of
ORAMORPH
This medicine contains:
• Ethanol (Alcohol): This product contains 10 volume % ethanol
(alcohol). Each dose contains up to 0.81 g of alcohol which is
equivalent to 20 ml beer or 8.3 ml wine. This medicine is harmful if
you are addicted to alcohol. The amount of alcohol should also be
considered if you are pregnant or breast-feeding, have long term
(chronic) liver problems or epilepsy, or you are a child
• Sucrose: This product contains 30 g of sucrose in the 100 ml
bottle, 90 g of sucrose in the 300 ml bottle, and 150 g of sucrose
in the 500 ml bottle. When taken according to the dosage
recommendations each dose supplies up to 3 g of sucrose. You
should not take this product if you have a bowel condition that
makes you intolerant to some sugars such as fructose, glucose,
galactose or sucrose
• Methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) - These may cause allergic
reactions in some people that could occur some time after
taking this medicine. The signs may include swelling of the
mouth and face, sudden breathing difficulties and your blood
pressure being lower than normal
3. HOW TO TAKE ORAMORPH ORAL SOLUTION
Always take this medicine exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.
Taking this medicine
• Take this medicine by mouth
• Use a 5 ml plastic spoon to measure your dose
• They are available from your pharmacist
437736/GB/12

Mandatory in

File information

TD

PITCH CODE

Printfile

Issue date of TD:

25.05.2010

Yes

PPM SKU:

P004062

No

012

No

Yes

Issue date of artwork:

08.09.2010

No

Yes

Print colors:

PAN Black

No

2 mm

Yes

PPM SKU version: 

= 0,35 mm

Yes

Yes

= 1 mm

= 10 mm

Mat. No. Pack. Site:

437736/GB/12

Legend case version:

V1.0 01/DEC/2009 (please do not change or remove it)

No

5 mm

1 mm

Yes
= 0,65 mm

Technical information

= 9 mm

= 46,5 mm

a = Batch No.

b = Expiry date

c = Manufacturing date

d = Price/Sample/Clinic

Technical colors
BI-Diecut-Legendcase

Free area

Additional Requirements of Packaging Site
Dimensions: mm 200 x 305 folded to 200 x 36mm

Gluepoints

= 2 mm

How much to take
Your doctor will decide the amount of medicine to give you.
Adults
• The usual dose is 5 to 10 ml (one to two teaspoons) every four
hours
Paediatric population

Children 13 to 18 years
• The most that should be taken is 2.5 to 10 ml (half to two
teaspoons) every four hours
Children 6 to 12 years
• The most that should be taken is 2.5 to 5 ml (half to one
teaspoon) every four hours
Children 1 to 5 years
• The most that should be taken is 2.5 ml (half a teaspoon)
every four hours
Children under 1 year
• Do not give this medicine to children under 1 year
Being given more or less of this medicine
• For some people, it may be necessary for the doctor to give a
higher dose
• For other people (for example the elderly, people with kidney or
liver problems and people that should not be sedated) the
doctor may decide to use a lower dose
Your body may get used to the medicine (tolerance)
• Do not take more than your doctor has prescribed
• If you have been taking your medicine for some time you may
find that it does not seem to be working as well as it did. If this
happens, talk to your doctor

Other side effects
• Feeling sick (nausea) or being sick (vomiting)
• Constipation, which can be treated with appropriate laxatives
• Difficulty in passing water (urine)
• Feeling drowsy
• Dry mouth, sweating and flushing of your face
• Your heart rate getting faster (tachycardia) or slower
(bradycardia) or fast and uneven (palpitations)
• Lower body temperature (hypothermia)
• Lowered sex drive
• Seeing or hearing things that are not there (hallucinations) or
feeling confused
• Muscles feeling tense
• The black circle in the centre of your eyes (pupil) getting smaller
(miosis)
• Dependence on ORAMORPH. This can happen with any
morphine product
If any of the side effects gets troublesome or serious, or if you
notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE ORAMORPH ORAL SOLUTION
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on
the bottle label and the outer carton. The expiry date refers to the
last day of the month.
Do not store ORAMORPH above 25°C.
Store in the original container in order to protect from light.
Please return any remaining medicine to your pharmacist
3 months after first opening.

If you take more ORAMORPH than you should
If you take more of this medicine than you should, talk to a
doctor or go to a hospital straight away. Take the medicine pack
with you. This is so the doctor knows what you have taken.

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect
the environment.

If you take more than you should, the following effects may
happen:
• The black circle in the centre of your eyes (pupil) gets smaller
• You breath more slowly
• You have low blood pressure

6. FURTHER INFORMATION

In more severe cases, very high doses could cause your blood
circulation to slow down and cause unconsciousness for a long
time, or even death. In children a high dose may cause fits
(convulsions).
If you forget to take ORAMORPH
• If you forget a dose, take it as soon as you remember it and take
your next dose at the usual time
• If it is nearly time for the next dose, skip the missed dose. This is
because the time between doses should be at least 4 hours
• Do not take a double dose to make up for a forgotten dose
If you stop taking ORAMORPH
It is important to talk to your doctor if you want to stop taking
your medicine. Do not stop taking your medicine suddenly. This is
because your body may have got used to it. Also, you may need to
have your dose lowered slowly.
4. POSSIBLE SIDE EFFECTS
Like all medicines, ORAMORPH can cause side effects, although
not everybody gets them. The following side effects may happen
with this medicine:
Allergic reactions
If you have a severe allergic reaction, stop taking this medicine
and see a doctor straight away. Signs may include swelling of the
mouth and face, difficulty breathing, dizziness and skin reactions
such as rash and itching.
Tell your doctor straight away if you notice the following side
effects. You may need urgent medical treatment:
• Having a headache. This could be a sign of raised pressure
inside your skull
• Feeling dizzy or unsteady when you stand up. This could be a
sign of a temporary fall in blood pressure (orthostatic
hypotension)
• Shallow breathing, with a slow heartbeat (bradycardia) and cold
clammy skin
• Feeling restless, irritable or having changes in your mood
• Stomach pain caused by spasm (cramps) of the tubes that carry
urine to the bladder or bile to the intestines

What ORAMORPH contains
• Each 5 ml contains 10 mg of morphine sulphate as the active
ingredient
• The other ingredients are alcohol (ethanol), corn syrup, sucrose,
methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216) and purified water
What ORAMORPH looks like and content of the pack
ORAMORPH is a solution and is available in bottles of 100, 250,
300 and 500 ml. The bottles come in cartons.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for ORAMORPH is held by:
Boehringer Ingelheim Limited,
Ellesfield Avenue,
Bracknell, Berkshire,
RG12 8YS, United Kingdom
and the solution is manufactured by:
Istituto de Angeli S.r.l. at:
Località Prulli Si Sotto n. 103/C
50066 Reggello (FI)
Italy
This leaflet was revised in June 2010.
© Boehringer Ingelheim Limited 2010

437736/GB/12

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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