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FENYLAT 75 MICROGRAMS/HOUR TRANSDERMAL PATCH

Active substance(s): FENTANYL

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Transcript
Product:

Fenylat 12 / 25 /
50 / 75 / 100 µg/h
Transdermal patch

Printing Colours:

Non-Printing Colours:

Black

Profile

MA Holder:

Activase

PL No.:

28444/0125-0129

Pack Size:

All

Dimensions:

480 x 280 mm

Livery:

Activase

Created By:

DTawde

Manufacturer:

-

Artwork Code:

A0125-0129/O/PIL/A3

Bar Code:

-

Font Type:
Font Size:

Fruitiger Roman
9 pt

Market:

UK

Component:

Leaflet

Final Preparation Date For Submission: 07/11/2014

Packing Site Technical Approval:

10/11/2014
Authority Approval Date:
Latest Implementation Deadline:
Print Proof Approval:

00/00/0000
00/00/0000
00/00/0000

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Fenylat
12 / 25 / 50 / 75 / 100
micrograms/hour
Transdermal Patch
Fentanyl
Important things you need to know about
Fenylat Transdermal Patches
• These patches contain a strong pain killer
• Ensure that old patches are removed before
applying a new one
• Patches must not be cut
• Do not expose the patches to a heat source
(such as a hot water bottle)
• If you develop a fever tell your doctor
immediately
• Follow the dosage instructions carefully and
only change your patch every 72 hours
• If your breathing becomes shallow and weak
take the patch off and seek medical help
Read all of this leaflet carefully before you
start using 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
only. Do not pass it on to others. It may
harm them, even if their symptoms are the
same as yours.
• If you get any side effects talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.

WHAT FENYLAT IS AND
WHAT IT IS USED FOR

What is in this leaflet:
1. What Fenylat is and what it is used for
2. What you need to know before you use Fenylat
3. How to use Fenylat
4. Possible side effects
5. How to store Fenylat
6. Contents of the pack and other information

1

Fenylat is a strong painkiller; its painkilling
activity is mediated through the central nervous
system.
Adults:
Fenylat is used for long-term management of
severe and long-lasting pain that can only be
managed adequately with strong pain relievers
(opioid analgesics).
Children:
Fenylat is used for long-term management of
severe chronic pain that can only be managed

WHAT YOU NEED TO KNOW
BEFORE YOU USE FENYLAT

adequately with strong pain relievers (opioid
analgesics) in children aged 2 years or older who
have previously been treated with opioid
analgesics.

2
Do not use Fenylat:
• if you are hypersensitive (allergic) to fentanyl,
peanut, soya or any of the other ingredients of
this medicine (listed in section 6).
• if you suffer from pain which lasts only for a
short period, e. g. after a surgical procedure.
• if your central nervous system is severely
impaired, for instance by brain injury.
• if your breathing function is severely impaired.
Warnings and precautions
Talk to your doctor before using Fenylat
Warning
Fenylat is a medicinal product that could be
life-threatening to children.
This is also the case with used transdermal
patches.
Bear in mind that the design of this medicinal
product could be tempting to a child which in
some cases may lead to a fatal outcome.
Fenylat can have life-threatening side-effects in
persons that are not using prescribed opioid
medicines on a regular basis.
This medicine should only be used under the
supervision of a doctor who is experienced in the
treatment of pain.
Your doctor will use treatment with Fenylat as a
part of an integrated management of pain and
will assess you for your individual response to
Fenylat at regular intervals.
As strong pain relievers may cause breathing
problems, Fenylat should be used with caution,
under special supervision and at low doses in
patients with
• existing breathing problems (respiratory
depression), asthma. Breathing difficulties may
continue or re-occur following removal of the
transdermal patch, therefore, you must be
monitored for these signs. The probability of
these side-effects increases with increasing
doses and may be increased by medicines
affecting brain function (see section “Using
other medicines”)
• diseases of the lungs, e.g. chronic pulmonary
disease (CPD), as breathing may be reduced
• impaired liver and/or kidney function as
excretion of fentanyl may be delayed
• Take special care if you develop a fever while
wearing Fenylat, tell your doctor as this may
affect the way the medicine passes through
your skin.
• Do not expose the patch to a direct heat
source such as heating pads, hot water bottles,
electric blankets, heat lamps, saunas and hot
whirlpool spa baths. These may affect the way
the medicine works.
Check with your doctor or pharmacist before
using this medicine:
• If you have severe side-effects. Following
removal of Fenylat you should be monitored

for at least 24 hours or longer, depending on
your symptoms.
• If you have had a head injury, a brain tumour,
signs of increased intracranial pressure,
changes in your state of consciousness or loss
of consciousness or coma. Strong pain relievers
(opioids) may mask the course of head injury.
• If you have a too slow, irregular heartbeat
(bradyarrhythmia)
• If you have low blood pressure or lack of fluid
(hypovolaemia). This should be treated prior to
initiation of treatment with Fenylat.
• If you are at an advanced age.
• If you suffer from long-lasting constipation.
• If you have existing or suspected loss of muscle
function of the bowel: treatment with Fenylat
must be stopped.
• If you suffer from myasthenia gravis (a disease
causing tiredness and weakness of the
muscles).
• If you are addicted to medicines or alcohol or
have a history of drug abuse.
Repeated use of strong pain relievers (opioids)
may lead to physical or psychological
dependence. However, this is rarely seen when
opioids are prescribed by a doctor (see section
“Possible side effects”).
Do not cut Fenylat patches. The patches should be
checked before use. A divided, cut or in any way
damaged patch should not be used.
Patch sticking to another person
The patch should only be used on the skin of the
person for whom it was ordered by the doctor.
Cases have been reported where a patch was
accidentally stuck to a family member while in
close physical contact or sharing the same bed as
the patch wearer. A patch sticking to another
person (particularly a child) may result in an
overdose. In case the patch sticks to the skin of
another person, take the patch off immediately
and seek medical attention.
Children and adolescents
Fenylat should not be administered to children,
who have not been treated with opioids before.
Patients may experience with a significant or
life-threating respiratory depression.
Fentanyl Transdermal Patch has not been studied
in children under 2 years of age. Fenylat should
be administered only to opioid-tolerant children
age 2 years or older (please see “How to use
Fenylat”). Fenylat should not be used in children
under 2 years of age.
To minimise the potential of young children
removing and consuming the patch, the site of
administration should be chosen carefully. The
adhesion of the patch should be monitored
carefully and if necessary the patch should be
reapplied. The patch should be applied, removed
and disposed of by a clinical person, a doctor or
by an adult attending the child and not by the
child. Fenylat should be stored out of the sight
and reach of children before and after
administration.
Misuse for doping (cheating at competitive
events)
The use of Fenylat can lead to positive results in
doping tests. Using Fenylat for doping reasons
can result in a risk to your health.

Other medicines and Fenylat
Tell your doctor or pharmacist if you are using,
have recently used or might use any other
medicines. This includes medicines that you buy
without a prescription.

If you take any of the following medicines, an
interactive increase of the central depression is to
be expected and side effects like difficulty in
breathing,
low
blood
pressure,
severe
sleepiness/coma and death are possible:
• strong painkillers
• depressants and hypnotics
• medicines used to put you to sleep or for
relaxation of your muscles (in the case of a
planned medical or dental procedures with
anaesthesia/narcosis, please inform your
doctor or dentist that you are using Fenylat
• phenothiazines (medicines to treat neuroleptic
disease)
• medicines used for treating anxiety
• medicines used for treating allergies
(antihistamines that make you feel tired)
• alcohol

The concomitant use with specific medicines
(CYP3A4 inhibitors) may reduce the breakdown
of fentanyl in the liver which could increase or
prolong the therapeutic effects and side effects,
e.g.:
• ritonavir, nefinavir (medicines to treat viruses)
• ketoconazole, itraconazole, fluconazole,
voriconazole (medicines to treat fungal
diseases)
• troleandomycin, clarithromycin (antibiotics)
• nefazodone (medicine to treat depression)
• verapamil, diltiazem (medicines to treat heart
disease and high blood pressure)
• amiodarone (medicine to treat a heart
problem called arrhythmia)

Concomitant use of specific medicines (CYP3A4
inducers) may increase breakdown of fentanyl in
the liver, which could decrease the therapeutic
effects, e.g.
• rifampicin (antibiotic)
• carbamazepine, phenobarbital, phenytoin (for
treatment of epilepsy)

Once you stop these medicines (CYP3A4 inducers)
it may increase or prolong the therapeutic effects
and side-effects of fentanyl which can affect your
breathing. In this situation you will require
special monitoring and your dose will be
adjusted.

You should not use Fenylat if you are taking
Monoamine Oxidase Inhibitors (MAOI) (for
treatment of depression or Parkinson’s disease) or
have taken them within the last 14 days.

Please tell your doctor if you are taking special
medicines against depression, known as Selective
Serotonin Re-uptake Inhibitor (SSRI), or Serotonin
Noradrenaline Re-uptake Inhibitor (SNRI) or a
Monoamine Oxidase Inhibitor (MAOI).

Your doctor should know of any treatment with
these medicines as the concomitant use with
Fenylat may increase the risk for the potentially
life-threatening serotonin syndrome.

If you are using Fenylat you should not take other
painkillers like buprenorphine, nalbuphine or
pentazocine, because they could counteract the
effects of fentanyl (e.g. analgesic effect) and may
cause withdrawal symptoms in people who are
dependent on opioids.

Fenylat with food, drink and alcohol
Patients treated with Fenylat should not drink
alcohol.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Pregnancy
There is no adequate data from the use of
fentanyl, the active ingredient of Fenylat in
pregnant women. Therefore you should not use
Fenylat during pregnancy unless your doctor
decides it is necessary. There is a risk of neonatal
withdrawal syndrome in new-born infants where
the mother has used transdermal fentanyl a lot
during pregnancy.
Use of Fenylat during childbirth is not
recommended because fentanyl passes through
the placenta and may cause breathing problems
in the new-born child.
Breast-feeding
Fentanyl passes into the breast-milk. Therefore
breast-feeding should be stopped during
treatment with Fenylat and for at least 72 hours
after removal of the patch.

Driving and using machines
Fenylat can affect your ability to drive and use
machines as it may make you feel sleepy or dizzy.
In patients on a stable fentanyl dose, a significant
impairment of the ability to drive and use
machines is not expected. However at the
beginning of treatment, upon increase of dose or
upon combination with other medicinal products,
some people’s reactions may be affected, leading
to impairment of the ability to drive or use
machines. Such situations should be handled with
caution.

During treatment with Fenylat do not drive or use
machines, nor do so for at least 24 hours after the
end of treatment.
• It is an offence to drive if this medicine affects
your ability to drive.
• However, you would not be committing an
offence if:
• Fenylat has been prescribed to treat a
medical or dental problem and;
• you have taken it according to the
instructions given by the prescriber or in the
information provided with the medicine
and;
• it was not affecting your ability to drive
safely.
Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while
taking this medicine.

Fenylat contains soya oil
If you are allergic to peanut or soya, do not use
this medicinal product.

3

HOW TO USE FENYLAT

Always use this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.

Change your patch
at the same time on
Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday

Using and changing the patches
• There is enough medicine in each patch to last
3 days (72 hours).
• You should change your patch every third day,
unless your doctor has told you otherwise.
• Always remove the old patch before applying
the new one.
• Always change your patch at the same time of
day every 3 days (72 hours).
• Make a note of the day, date and time you
apply a patch, to remind you when you need
to change your patch
• The following table shows you which day of
the week to change your patch:

Apply your
patch on
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday

Where to apply the patch

Adults
• Apply the patch on a flat part of your upper
body or arm

Children
• Always apply the patch to the upper back to
make it difficult for your child to reach it or
take it off
• Every so often check that the patch remains
stuck to the skin.
• It is important that your child does not remove
the patch and put it in their mouth as this
could be life-threatening or even fatal.
• It may take some time before the patch
becomes fully effective. Therefore, your child
might need additional painkillers until the
patch becomes effective. Your doctor will
advise you on this if it is needed.

• Children need to be monitored very closely for
48 hours after:
• the first patch has been put on
• a higher dose patch has been put on
For you or your child, do not apply the patch on:
• the same place twice in a row
• sensitive areas that you move a lot, skin with
cuts, spots or other skin blemishes
• skin that is very hairy. If there is hair, do not
shave it (shaving irritates the skin). Instead, clip
the hair as close to the skin as possible.
You should allow several days to pass before you
put a new patch on the same area of skin.
Putting a patch on
Step 1: Preparing the skin
• Make sure your skin is completely clean, dry
and cool before you put the patch on.
• If you need to clean the skin, just use cold
water.
• Do not use soap or any other cleansers,
creams, moisturisers, oils or talc before
applying the patch.
• Do not stick a patch on straight after a hot
bath or shower.
Step 2: Open the pouch
• Each patch is sealed in its own pouch.
• Tear or cut off the edge of the pouch
completely (if you use scissors, cut close to the
sealed edge of the pouch to avoid damaging
the patch).
• Grasp both sides of the opened pouch and pull
apart.
• Take the patch out and use it straight away.
• Keep the empty pouch to dispose of the used
patch later.
• Use each patch once only.
• Do not take the patch out of its pouch until
you are ready to use it.
• Inspect the patch for any damage.
• Do not use the patch if it has been divided, cut
or looks damages.
• Never divide or cut the patch.
Step 3: Peel and press
• Make sure that the patch will be covered by
loose clothing and not stuck under a tight or
elasticated band.
• Carefully peel one half of the shiny plastic
backing away from the centre of the patch. Try
not to touch the sticky side of the patch.
• Press this sticky part of the patch onto the skin.
• Remove the other part of the backing and
press the whole patch onto the skin with the
palm of your hand.
• Hold for at least 30 seconds. Make sure it sticks
well, especially the edges.
Step 4: Disposing of the patch
• As soon as you take the patch off, fold it firmly
in half so that the sticky side sticks to itself.
• Put it back in its original pouch and put the
pouch in the bin with your household
rubbish.
• Even used patches contain some medicine
which may harm children, so keep your used
patches out of the sight and reach of
children.

Step 5: Wash
• Wash your hands afterwards with clean water.
How quickly will the patches work?
• It may take up to a day before your first patch
is working completely.
• Your doctor may give you extra painkillers for
the first day or so.
• After this, the patch should help to relieve
pain continuously so that you can stop taking
other painkillers. However, your doctor may
still prescribe extra painkillers from time to
time.
If you forget to change your patch
• If you forget, change your patch as soon as
you remember and make a note of the day
and time. Change the patch again after 3 days
(72 hours) as usual.
• If you are very late changing your patch, you
should talk to your doctor because you might
need some extra painkillers, but do not apply
an extra patch.
If you use too many patches or the wrong
strength patch
If you have stuck on too many patches or the
wrong strength patch, take the patches off and
contact a doctor or the nearest hospital straight
away.
Signs of overdose include trouble breathing or
shallow breathing, tiredness, extreme sleepiness,
being unable to think clearly, walk or talk
normally and feeling faint, dizzy or confused.
If a patch falls off
• If a patch falls off before it needs changing,
stick a new one on straight away and make a
note of the day and time. Use a new area of
skin on:
• your upper body or arm
• your child’s upper back
• Leave another 3 days (72 hours) before
changing the new patch as usual.
• If your patch keeps falling off, talk to your
doctor, nurse or pharmacist.
If a patch sticks to another person
• Only use the patch on the skin of the person
who it is prescribed for.
• Make sure the patch does not get rubbed off
and stick to your partner or child, especially
while sharing a bed in close contact.
• If a patch accidentally sticks to another person,
take it off straight away and seek immediate
medical attention.
If your pain gets worse
• If your pain gets worse while you are using
these patches, your doctor may try a higher
strength patch, or give you extra painkillers (or
both).
• If increasing the strength of the patch does
not help, your doctor may stop the patches.
If you want to stop using the patches
• Talk to your doctor before you stop using
these patches.
• If you have been using them for some time
your body may have got used to them.
Stopping suddenly may make you feel unwell.

• If you stop using the patches, don’t start again
without asking your doctor first. You might
need a different patch strength when you
restart.

POSSIBLE SIDE EFFECTS

If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Take the patch off and tell your doctor, or go to
the nearest hospital, straight away if you notice
or suspect any of the following. You may need
urgent medical treatment.
• Feeling unusually drowsy, breathing more
slowly or weakly than expected.
• Very rarely these breathing difficulties can be
life threatening or even fatal especially in
people who have not used strong opioid
painkillers before.
If you notice any of the above, follow the
guidance above and keep moving as much as
possible.
If any of the following side effects occur you
should discontinue treatment and immediately
contact your doctor or visit a hospital.
Very common: may affect more than 1 in 10
people
• sleepiness, dizziness, headache
• nausea, vomiting, constipation
Common: may affect up to 1 in 10 people
• hypersensitivity of the immune system
• loss of appetite
• not able to sleep, depression, anxiety, feeling
confused, hallucinations
• tremor, pins and needles
• conjunctivitis (an eye infection)
• vertigo (feeling sick and dizzy)
• palpitations and an increase in heart rate
• increase in blood pressure
• shortness of breath
• diarrhoea, dry mouth, stomach pain,
indigestion
• increased sweating, itching, rash, skin
reddening
• muscle spasms
• difficulty passing urine
• tiredness, swelling, particularly in feet ankles
and hands (peripheral oedema), rapid
tiredness (asthenia), a feeling of discomfort
and uneasiness (malaise), feeling cold
Uncommon: may affect up to 1 in 100 people
• agitation, disorientation, Unnatural feeling of
happiness,
• reduced sensation to touch (hypaesthesia),
convulsions (including clinic and Grand Mal
seizures), memory gaps, speech disturbances
• decreased heart rate, blue colouration of the
skin (cyanosis)
low blood pressure
difficulties in breathing and breathlessness
blockage of the intestine
eczema, allergic rashes, skin disorders, contact
dermatitis





• muscle twitching
• erectile dysfunction, sexual dysfunction
• application site reaction flu-like illness, feeling
of body temperature change, application site
hypersensitivity, withdrawal symptoms
• fever

Rare: may affect up to 1 in 1,000 people
• “pin-point” like pupils (miosis)
• irregular heartbeat (arrhythmia)
• flushing from dilation of blood vessels
(vasodilatation)
• stopping breathing, shallow or too slow
breathing (hypoventilation)
• partial blockage of the intestine
• skin inflammation and itching at the site
where the patch was applied

Very rare: may affect up to 1 in 10,000 people
• painful gas
• less urine being passed and pain in the bladder

Not known: frequency cannot be estimated from
the available data
• life threatening allergic reactions (anaphylactic
shock), allergic reactions of different causes
(anaphylactic or anaphylactoid reactions)
• slowed breathing (bradypnoea)

Other possible side effect
Tolerance of the medicine, leading to a physical
dependence and psychological dependence can
develop with repeated use of Fenylat (see section
“Take special care with Fenylat”).
Opioid withdrawal symptoms (such as nausea,
vomiting, diarrhoea, anxiety, and shivering) are
possible in some patients after conversion from
their previous opioid analgesic to Fenylat or if
therapy is stopped suddenly (see section “Take
special care with Fenylat”).
There have been very rare reports of new-born
infants experiencing neonatal withdrawal
syndrome when mothers used Fenylat a lot
during pregnancy (see section “Take special care
with Fenylat”).
In very rare cases soya oil may cause allergic
reactions.

Additional side effects in children and
adolescents
The side-effects in children and adolescents
treated with Fenylat Transdermal Patches is
similar to the side effects observed in adults.
Apart from side-effects that can usually be
expected during treatment of pain in severely ill
children, no additional risks are known when
Fenylat is given to children aged 2 years or older
at 100 µg/hour as directed.
Very common side-effects reported in the clinical
trials performed in severely ill children were
fever, headaches, vomiting, nausea, constipation,
diarrhoea and itching.

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report any
side effects directly via the Yellow Card Scheme
[www.mhra.gov.uk/yellowcard]. By reporting
side effects you can help provide more
information on the safety of this medicine.

5

HOW TO STORE FENYLAT

Keep this medicine out of the sight and reach of
children both before and after use.

Do not use this medicine after the expiry date
which is stated on the label and outer packaging.
The expiry date refers to the last day of that
month.

This medicinal product does not require any
special storage conditions.

Disposal information

CONTENTS OF THE PACK AND
OTHER INFORMATION

Do not throw away any medicines via wastewater
or household waste. Please fold the used
transdermal patch with the adhesive surfaces
inwards and discard it according to your national
requirement and out of reach of children safely.
Ask your pharmacist how to throw away
medicines you no longer use. These measures will
help to protect the environment.

6

What Fenylat contains
The active substance is fentanyl.

Fenylat 12 µg/h: 1 transdermal patch contains
2.55 mg fentanyl in a patch size of 4.25 cm2 and
releases 12.5 micrograms fentanyl per hour.

Fenylat 25 µg/h: 1 transdermal patch contains 5.1
mg fentanyl in a patch size of 8.5 cm2 and releases
25 micrograms fentanyl per hour.

Fenylat 50 µg/h: 1 transdermal patch contains
10.2 mg fentanyl in a patch size of 17 cm2 and
releases 50 micrograms fentanyl per hour.

Fenylat 75 µg/h: 1 transdermal patch contains
15.3 mg fentanyl in a patch size of 25.5 cm2 and
releases 75 micrograms fentanyl per hour.

Fenylat 100 µg/h: 1 transdermal patch contains
20.4 mg fentanyl in a patch size of 34 cm2 and
releases 100 micrograms fentanyl per hour.

The other ingredients are:
Matrix components: aloe vera leaf extract oil (on
the basis of soya oil tocopherol acetate),
colophonium resin, poly (2-ethylhexylacrylate,
vinyl acetate) (50:50)
Release liner: polyethylene terephthalate,
polyester foil, siliconized
Backing foil with imprint: polyethylene
terephthalate foil, printing ink

What Fenylat looks like and contents of the pack
Transdermal patch

Opaque, colourless, rectangular shaped patch
with round corners and imprint on the backing
foil “Fentanyl 12 µg/h” in single sealed sachets.

Opaque, colourless, rectangular shaped patch
with round corners and imprint on the backing
foil: “Fentanyl 25 µg/h” in single sealed sachets.

Opaque, colourless, rectangular shaped patch
with round corners and imprint on the backing
foil: “Fentanyl 50 µg/h” in single sealed sachets.

Opaque, colourless, rectangular shaped patch
with round corners and imprint on the backing
foil: “Fentanyl 75 µg/h” in single sealed sachets.

Opaque, colourless, rectangular shaped patch
with round corners and imprint on the backing
foil: “Fentanyl 100 µg/h” in single sealed sachets.

Fenylat is available in packs containing 5, 10 and
20 transdermal patches.

Marketing Authorisation Holder:
Activase Pharmaceuticals Ltd.,
11 Boumpoulinas, 3rd Floor,
P.C. 1060 Nicosia, Cyprus

Manufacturer:
Acino AG,
Am Windfeld 35,
83714 Miesbach

This leaflet was last revised in 11/2014
A0125-0129/O/PIL/A3

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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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