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ARISTIGA 40 MG/20 MG PROLONGED-RELEASE TABLETS

Active substance(s): NALOXONE HYDROCHLORIDE DIHYDRATE / OXYCODONE HYDROCHLORIDE

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Oxycodone / Naloxone 5/2.5 mg, 10/5 mg, 20/10 mg and 40/20 mg, prolonged release tablets
1.3.1.2 - Package Leaflet

Package leaflet: Information for the user
Aristiga 5 mg/2.5 mg prolonged-release tablets
Aristiga 10 mg/5 mg prolonged-release tablets
Aristiga 20 mg/10 mg prolonged-release tablets
Aristiga 40 mg/20 mg prolonged-release tablets
oxycodone hydrochloride / naloxone hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
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 signs of illness 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. See section 4.
What is in this leaflet:
1.
What Aristiga is and what it is used for
2.
What you need to know before you take Aristiga
3.
How to take Aristiga
4.
Possible side effects
5.
How to store Aristiga
6.
Contents of the pack and other information

1.

What Aristiga is and what it is used for

Aristiga is a prolonged-release tablet, which means that its active substances are released over an
extended period. Their action lasts for 12 hours.
These tablets are only for use in adults.
Pain relief
You have been prescribed Aristiga for the treatment of severe pain, which can be adequately managed
only with opioid analgesics. Naloxone hydrochloride is added to counteract constipation.
How these tablets work in pain relief
These tablets contain oxycodone hydrochloride and naloxone hydrochloride as active substances.
Oxycodone hydrochloride is responsible for the pain-killing effect of Aristiga, and is a potent
analgesic (“painkiller”) of the opioid group. The second active substance of Aristiga, naloxone
hydrochloride, is intended to counteract constipation. Bowel dysfunction (e.g. constipation) is a typical
side effect of treatment with opioid painkillers.

2.

What you need to know before you take Aristiga

Do not take Aristiga:
 if you are allergic to oxycodone hydrochloride, naloxone hydrorochloride or any of the other
ingredients of this medicine (listed in section 6),
 if your breathing is not able to supply enough oxygen to the blood, and get rid of carbon dioxide
produced in the body (respiratory depression),
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if you suffer from a severe lung disease associated with narrowing of the airways (chronic obstructive
pulmonary disease or COPD),
if you suffer from a condition known as cor pulmonale. In this condition the right side of the heart
becomes enlarged, due to increased pressure inside blood vessels in the lung etc (e.g. as a result of
COPD – see above),
if you suffer from severe bronchial asthma,
if you have paralytic ileus (a type of bowel obstruction) not caused by opioids,
if you have moderate to severe liver dysfunction.

Warnings and precautions
Talk to your doctor or pharmacist before taking Aristiga:
 in the case of elderly patients or debilitated (weak) patients,
 if you have paralytic ileus (a type of bowel obstruction) caused by opioids,
 if you have kidney impairment,
 if you have mild liver impairment,
 if you have severe lung impairment (i.e. reduced breathing capacity),
 if you have myxoedema (a thyroid disorder, with dryness, coldness and swelling [‘puffiness’] of the
skin, affecting the face and limbs),
 if your thyroid gland is not producing enough hormones (underactive thyroid, or hypothyroidism),
 if your adrenal glands are not producing enough hormones (adrenal insufficiency, or Addison’s
disease),
 if you have a mental illness accompanied by a (partial) loss of reality (psychosis), due to alcohol or
intoxication with other substances (substance-induced psychosis),
 if you suffer from gallstone problems,
 if your prostate gland is abnormally enlarged (prostate hypertrophy),
 if you suffer from alcoholism or delirium tremens,
 if your pancreas is inflamed (pancreatitis),
 if you have low blood pressure (hypotension),
 if you have high blood pressure (hypertension),
 if you have pre-existing cardiovascular disease,
 if you have a head injury (due to the risk of increased brain pressure),
 if you suffer from epilepsy or are prone to seizures,
 if you are also taking MAO inhibitors (used to treat depression or Parkinson’s disease), e.g. medicines
containing tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid.
Tell your doctor if any of the above has ever applied to you in the past. Also, please tell your doctor if
you develop any of the above disorders while you are taking these tablets. The most serious result of
opioid overdose is respiratory depression (slow and shallow breathing). This may also cause blood
oxygen levels to fall, resulting in possible fainting, etc.
You must swallow the prolonged-release tablet whole, so as not to affect the slow release of
oxycodone hydrochloride from the prolonged-release tablet. Do not break, chew or crush the tablets.
Taking broken, chewed or crushed tablets may lead to the absorption of a potentially lethal dose of
oxycodone hydrochloride (see section 3 “If you take more Aristiga than you should”).
If you experience severe diarrhoea at the start of treatment, this may be due to the effect of naloxone.
It may be a sign that bowel function is returning to normal. Such diarrhoea can occur within the first 35 days of treatment. If diarrhoea should persist after 3-5 days, or give you cause for concern, please
contact your doctor.

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If you have been using another opioid, withdrawal symptoms may occur when you initially switch to
Aristiga treatment, e.g. restlessness, bouts of sweating and muscle pain. If you experience such
symptoms, you may need to be specially monitored by your doctor.

If taken over the long term, you may become tolerant to these tablets. This means you may need a
higher dose to achieve the desired effect. Also, long-term use may lead to physical dependence.
Withdrawal symptoms may occur if treatment is stopped too suddenly (restlessness, bouts of sweating,
muscle pain). If you no longer need treatment, you should reduce your daily dose gradually, in
consultation with your doctor.
The active substance oxycodone hydrochloride alone has an abuse profile similar to other strong
opioids (strong analgesics). There is potential for development of psychological dependence.
Oxycodone hydrochloride containing products should be avoided in patients with a present or past
abuse of alcohol, drugs or medicines.
Tell your doctor in case you have cancer associated to peritoneal metastases or beginning bowel
obstruction in advanced stages of digestive and pelvic cancers.
If you need to undergo surgery, please tell your doctors that you are taking Aristiga.
You may notice remnants of the prolonged-release tablet in your stools. Do not be alarmed, as the
active substances (oxycodone hydrochloride and naloxone hydrochloride) have already been released
in the stomach and gut, and absorbed into your body.
Incorrect use of Aristiga
These tablets are not suitable for withdrawal treatment.
Aristiga should never be abused, particularly if you have a drug addiction. If you are addicted to
substances such as heroin, morphine or methadone, severe withdrawal symptoms are likely if you
abuse these tablets because they contain the ingredient naloxone. Pre-existing withdrawal symptoms
may be made worse.
You should never misuse these tablets by dissolving and injecting them (e.g. into a blood vessel). In
particular, they contain talc, which can cause destruction of local tissue (necrosis) and changes in lung
tissue (lung granuloma). Such abuse can also have other serious consequences and may even be fatal.
The use of Aristiga may produce positive results in doping controls.
The use of Aristiga as a doping agent may become a health hazard.
Other medicines and Aristiga
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
If you take these tablets at the same time as you take other medicines, the effect of these tablets or the
other medicine may be changed. Tell your doctor if you are taking:
 other potent painkillers (opioids);
 sleep medication and tranquilisers (sedatives, hypnotics);
 medicines to treat depression;medicines used to treat allergies, travel sickness or nausea
(antihistamines or antiemetics);
 medicines to treat psychiatric or mental disorders (phenothiazines, neuroleptics, antipsychotics);
 medicines that decrease the blood’s clotting ability (coumarin derivatives), this clotting time may
be speeded up or slowed down;
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antibiotics of the macrolide type (such as clarithromycin, erythromycin or telithromycin);
antifungal medicines of the –azole type (e.g. ketoconazole, voriconazole, itraconizole or
posaconizole);
a specific type of medicine known as a protease inhibitor used to treat HIV (examples include
ritonavir indinavir, nelfinavir or saquinavir);
cimetidine (a medicine for stomach ulcers, indigestion or heartburn);
rifampicin (used to treat tuberculosis);
carbamazepine (used to treat seizures, fits or convulsions and certain pain conditions);
phenytoin (used to treat seizures, fits or convulsions);
a herbal remedy called St John’s Wort (also known as Hypericum perforatum);
quinidine (a medicine to treat an irregular heartbeat).

No interactions are expected between Aristiga and paracetamol, acetylsalicylic acid or naltrexone.
Aristiga with food, drink and alcohol
Drinking alcohol whilst taking Aristiga may make you feel more sleepy or increase the risk of serious
side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is
recommended not to drink alcohol while you’re taking Aristiga.
You should avoid drinking grapefruit juice while you are taking these tablets.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Use of these tablets should be avoided to the extent possible during pregnancy. If used over prolonged
periods during pregnancy, oxycodone hydrochloride may lead to withdrawal symptoms in newborn
infants. If oxycodone hydrochloride is given during childbirth, respiratory depression (slow and
shallow breathing) may occur in the newborn infant.
Breastfeeding
Breastfeeding should be discontinued during treatment with these tablets. Oxycodone hydrochloride
passes into breast milk. It is not known whether naloxone hydrochloride also passes into breast milk.
Therefore, a risk for the suckling infant cannot be excluded in particular following intake of multiple
doses of Aristiga.
Driving and using machines
Aristiga may affect your ability to drive or operate machines. In particular, this is likely at the start of
Aristiga, after a dose increase or after switching from a different medication. However, these side
effects disappear once you are on a stable Aristiga dose.
Ask your doctor whether you may drive or operate machines.

3.

How to take Aristiga

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

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Aristiga is a prolonged-release tablet, which means that its active substances are released over an
extended period. Their action lasts for 12 hours.
You must swallow the prolonged-release tablet whole, so as not to affect the slow release of
oxycodone hydrochloride from the prolonged-release tablet. Do not break, chew or crush the tablets.
Taking broken, chewed or crushed tablets may lead to the absorption of a potentially lethal dose of
oxycodone hydrochloride (see section 3 “If you take more Aristiga than you should”).
Unless otherwise prescribed by your doctor, the usual dose is:
To treat pain
Adults
The usual starting dose is 10 mg oxycodone hydrochloride / 5 mg naloxone hydrochloride as
prolonged release tablet(s) every 12 hours.
Your doctor will decide how much you should take every day and how to divide your total daily
dosage into morning and evening doses. Your doctor will also decide on any necessary dose
adjustments during treatment. Your dose will be adjusted according to your level of pain and
individual sensitivity. You should be given the lowest dose needed for pain relief. If you have already
been treated with opioids, Aristiga treatment can be started at a higher dose.
The maximum daily dose is 160 mg oxycodone hydrochloride and 80 mg naloxone hydrochloride. If
you need a higher dose, your doctor may give you additional oxycodone hydrochloride without
naloxone hydrochloride. However, the maximum daily dose of oxycodone hydrochloride should not
exceed 400 mg. The beneficial effect of naloxone hydrochloride on bowel activity may be affected if
additional oxycodone hydrochloride is given without additional naloxone hydrochloride.
If you are switched from these tablets to another opioid pain medication your bowel function will
probably worsen.
If you experience pain between two doses of Aristiga, you may need a rapid-acting painkiller. Aristiga
is not suitable for this. In this case, please talk to your doctor.
If you have the impression that the effect of these tablets is too strong or too weak, please talk to your
doctor or pharmacist.
Elderly
In general, no dose adjustment is necessary for elderly patients with normal kidney and/or liver
function.
Hepatic or renal impairment
If you have an impairment of your kidney function or a mild impairment of your liver function, your
attending doctor will prescribe these tablets with special caution. If you have a moderate or severe
impairment of liver function, these tablets should not be used (see also Section 2 “Do not take
Aristiga…” and “Warnings and precautions”).
Children and adolescents below 18 years of age
Aristiga has not yet been studied in children and adolescents under 18 years of age. Its safety and
effectiveness have not been proven in children and adolescents. For this reason, Aristiga use in
children and adolescents under 18 years of age is not recommended.
Method of administration
Oral use.
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Swallow these tablets whole (without chewing), with sufficient liquid (½ glass of water). You can take
the prolonged-release tablets with or without food. Take the tablets every 12 hours, according to a
fixed time schedule (e.g. at 8 o’clock in the morning and 8 o’clock in the evening). Do not break,
chew or crush the prolonged-release tablets (see section 2 “Warnings and precautions”).
Opening instructions:
This medicinal product is available in peelable, child resistant perforated unit dose blisters.

Pull off a single dose by tearing along the perforated line on the blister and peel back the foil on the
blister to expose the tablet.
Duration of use
In general, you should not take these tablets for any longer than you need to. If you are on long-term
treatment, your doctor should regularly check whether you still need these tablets.
If you take more Aristiga than you should
If you have taken more than the prescribed dose of these tablets you must inform your doctor
immediately.
An overdose may result in:
 narrowed pupils
 slow and shallow breathing (respiratory depression)
 drowsiness up to loss of consciousness)
 low muscle tone (hypotonia)
 reduced pulse rate, and
 a drop in blood pressure.
In severe cases, loss of consciousness (coma), fluid on the lungs and circulatory collapse may occur,
which may be fatal in some cases.
You should avoid situations which require a high level of alertness, e.g. driving.
If you forget to take Aristiga
Or if you take a dose lower than the one prescribed, you may not feel any effect.
If you should forget to take your dose, please follow the instructions below:
 If your next usual dose is due in 8 hours or more: Take the forgotten dose immediately and
continue with your normal dosing schedule.
 If your next usual dose is due within less than 8 hours: Take the forgotten dose. Then, wait another
8 hours before taking your next dose. Try to get back on track with your original dosing schedule
(e.g. 8 o’clock in the morning and 8 o’clock in the evening). Do not take more than one dose
within any 8-hour period.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Aristiga
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Do not stop your treatment without consulting your doctor.
If you do not require any further treatment, you must reduce the daily dose gradually after talking to
your doctor. In this way, you will avoid withdrawal symptoms, such as restlessness, bouts of sweating
and muscle pain.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects to look out for, and what to do if you are affected:
If you are affected by any of the following important side effects, consult your nearest doctor
immediately.
Slow and shallow breathing (respiratory depression) is the main danger of an opioid overdose. It
mostly occurs in elderly and debilitated (weak) patients. Opioids can also cause a severe drop in blood
pressure in susceptible patients.























Common (may affect up to 1 in 10 people)
 feel sick
 a feeling of unusual
weakness
 flatulence (wind)
 decreased appetite up to loss  tiredness or exhaustion
of appetite
 itchy skin
 a feeling of dizziness or
 skin reactions/rash
'spinning'
 sweating
 headache
 vertigo
 hot flushes
 difficulty in sleeping
 drowsiness
Uncommon (may affect up to 1 in 100 people)
 palpitations
abdominal bloating
 runny nose
 biliary colic
abnormal thoughts
 cough
 chest pain
anxiety
 hypersensitivity/ allergic
reactions
 generally feeling unwell
confusion
 injuries from accidents
 pain
depression
 swelling of hands, ankles or  increased urge to urinate
nervousness
feet
 muscle cramps
chest tightness especially if
 difficulties to concentrate
you already have coronary
 muscle twitches
heart disease
 impaired speaking
 muscle pain
drop in blood pressure
 shaking
 vision impairment
withdrawal symptoms such
 difficulties breathing
 epileptic seizures (especially
as agitation
in persons with epileptic
 restlessness
fainting
disorder or predisposition to
 chills
seizures)
lack of energy
 hepatic enzymes increased
thirst
 rise in blood pressure
altered taste
 reduced sexual drive
Rare (may affect up to 1 in 1,000 people)
increase in pulse rate
 dental changes
 weight gain
 yawning

abdominal pain
constipation
diarrhoea
dry mouth
indigestion
vomit (be sick)

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Not known (frequency cannot be estimated from the available data)
 hallucinations
 tingling skin (pins and
euphoric mood
needles)
 shallow breathing
severe drowsiness
 belching
 difficulties in passing urine
erectile dysfunction
nightmares

The active substance oxycodone hydrochloride, if not combined with naloxone hydrochloride, is
known to have the following differing side-effects:
Oxycodone can cause breathing problems (respiratory depression), reduction in size of the pupil in the
eye, cramping of the bronchial muscles and cramping of the smooth muscles, as well as depression of
the cough reflex.


















Common (may affect up to 1 in 10 people)
altered mood and
 decreased activity
 difficulties in passing urine
personality changes (e.g.
 increased activity
 hiccups
depression, feeling of
extreme happiness)
Uncommon (may affect up to 1 in 100 people)
 reduced sensitivity to pain
impaired concentration
 sore gums
or touch
migraines
 perception disturbances

abnormal
coordination
(e.g. hallucination,
increased muscle tension
derealisation)
 vocal changes (dysphonia)
involuntary muscle
 flushing of skin
 water retention
contractions
 dehydration
 difficulties in hearing
drug dependence
 agitation
 mouth ulcers
a condition where the
bowel stops working
 a decrease in sex hormone
 difficulties in swallowing
properly (ileus)
levels which may affect
sperm production in men or
dry skin
the menstrual cycle in
drug tolerance
females
Rare (may affect up to 1 in 1,000 people)
 increased appetite
itching rash (urticaria)
 bleeding gums
 black (tarry) stools
infections such as cold
sores or herpes (which may
cause blisters around the
mouth or genital area)
Not known (frequency cannot be estimated from the available data)
 absence of menstrual
 problems with bile flow
acute generalized allergic
periods
reactions (anaphylactic
 tooth decay
reactions)
 withdrawal symptoms in
the newborn
an increase in sensitivity to
pain
 aggression

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 side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine. By
reporting side effects you can help provide more information on the safety of this medicine.

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5.

How to store Aristiga

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What Aristiga contains
The active substances are oxycodone hydrochloride and naloxone hydrochloride.
Aristiga 5 mg/2.5 mg
Each prolonged-release tablet contains 5 mg oxycodone hydrochloride, equivalent to 4.5 mg
oxycodone, and 2.5 mg naloxone hydrochloride as 2.75 mg naloxone hydrochloride dihydrate,
equivalent to 2.25 mg naloxone.
Aristiga 10 mg/5 mg
Each prolonged-release tablet contains 10 mg oxycodone hydrochloride, equivalent to 9 mg
oxycodone, and 5 mg naloxone hydrochloride as 5.5 mg naloxone hydrochloride dihydrate, equivalent
to 4.5 mg naloxone.
Aristiga 20 mg/10 mg
Each prolonged-release tablet contains 20 mg oxycodone hydrochloride, equivalent to 18 mg
oxycodone, and 10 mg naloxone hydrochloride as 11.0 mg naloxone hydrochloride dihydrate,
equivalent to 9.01 mg naloxone.
Aristiga 40 mg/20 mg
Each prolonged-release tablet contains 40 mg oxycodone hydrochloride, equivalent to 36 mg
oxycodone, and 20 mg naloxone hydrochloride as 22 mg naloxone hydrochloride dihydrate, equivalent
to 18.02 mg naloxone.
The other ingredients are:
Tablet core:
hypromellose, polyvinyl acetate, povidone, sodium laurilsulfate, cellulose microcrystalline, silicon
dioxide, colloidal anhydrous silica, magnesium stearate.
Aristiga 5 mg/2.5 mg
Tablet coat:
polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, brillant blue FCF aluminum lake (E133)
Aristiga 10 mg/5 mg
Tablet coat:
polyvinyl alcohol, titanium dioxide, macrogol 3350, talc
Aristiga 20 mg/10 mg
Tablet coat:
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polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, red iron oxide (E172), yellow iron oxide
(E172)
Aristiga 40 mg/20 mg
Tablet coat:
polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, red iron oxide (E172) , yellow iron oxide
(E172), black iron oxide (E172)
What Aristiga looks like and contents of the pack
Prolonged-release tablet.
Aristiga 5 mg/2.5 mg
Blue, 9.6x4.8mm, elliptic, biconvex coated tablet, engraved with “5” on one side.
Aristiga 10 mg/5 mg
White to off-white, 9.6x4.8mm, elliptic, biconvex coated tablet, engraved with “10” on one side.
Aristiga 20 mg/10 mg
Pink, 9.6x4.8mm, elliptic, biconvex coated tablet, engraved with “20” on one side.
Aristiga 40 mg/20 mg
Yellow, 11x5.5mm, elliptic, biconvex coated tablet, engraved with “40” on one side.

Aristiga prolonged release tablets are available in peelable, child resistant perforated unit dose blisters
of: 10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1, 98x1, 100x1, 100x1 (Hospital pack) tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ethypharm
194 Bureaux de la Colline, Bâtiment D
92213 Saint Cloud cedex
France
Manufacturer
Ethypharm
Chemin de la Poudrière
76120 Le Grand Quevilly
France
This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany :
Ireland:
United Kingdom

Oxycodon-HCl/Naloxon-HCl Ethypharm 5 mg/2,5 mg, 10 mg/5 mg, 20
mg/10 mg and 40 mg/20 mg Retardtabletten
Aristiga 5 mg/2,5 mg, 10 mg/5 mg, 20 mg/10 mg, 40 mg/20 mg prolonged
release tablets
Aristiga 5 mg/2,5 mg, 10 mg/5 mg, 20 mg/10 mg, 40 mg/20 mg prolonged
release tablet

This leaflet was last revised in {12/2016}.

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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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