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RIBAVIRIN 200 MG CAPSULES HARD

Active substance(s): RIBAVIRIN

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Package leaflet: Information for the user

Ribavirin 200 mg capsules
Ribavirin
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 Ribavirin is and what it is used for
2. What you need to know before you take Ribavirin
3. How to take Ribavirin
4. Possible side effects
5. How to store Ribavirin
6. Contents of the pack and other information
1. What Ribavirin is and what it is used for
Ribavirin contain the active substance ribavirin. This medicine stops the
multiplication of hepatitis C virus. Ribavirin must not be used alone.
Depending on the genotype of the hepatitis C virus that you have, your doctor
may choose to treat you with a combination of this medicine with other
medicines. There may be some further treatment limitations if you have or have
not been previously treated for chronic hepatitis C infection. Your doctor will
recommend the best course of therapy.
The combination of Ribavirin and other medicines is used to treat adult patients
who have chronic hepatitis C (HCV), Ribavirin may be used in paediatric
patients (children 3 years of age and older and adolescents) who are not
previously treated and without severe liver disease.
For paediatric patients (children and adolescents) weighing less than 47 kg a
solution formulation is available.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.
2. What you need to know before you take Ribavirin
Do not take Ribavirin
Do not take Ribavirin if any of the following apply to you or the child you are
caring for.

blood abnormalities development (reduction in number of red blood cells
which carry oxygen, certain white blood cells that fight infection, and
blood clotting cells called platelets).
- With zidovudine or stavudine, it is not certain if this medicine will
change the way these medicines work. Therefore, your blood will be
checked regularly to be sure that the HIV infection is not getting worse. If
it gets worse, your doctor will decide whether or not your Ribavirin
treatment needs to be changed. Additionally, patients receiving
zidovudine with ribavirin in combination with alpha interferons could
be at increased risk of developing anaemia (low number of red blood
cells). Therefore the use of zidovudine and ribavirin in combination with
alpha interferons is not recommended.
- Due to the risk of lactic acidosis (a build-up of lactic acid in the body) and
pancreatitis, the use of ribavirin and didanosine is not recommended
and the use of ribavirin and stavudine should be avoided.
- Co-infected patients with advanced liver disease receiving (HAART) may
be at increased risk of worsening liver function. Adding treatment with
alfa interferons alone or in combination with ribavirin may increase the
risk in this patient subset.
Reminder: Please read the “Other medicines” section of the Package Leaflet for
the other medicines used in combination with Ribavirin before you begin
combination treatment with this medicine.
Pregnancy and breast-feeding and fertility
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.
If you are pregnant you must not take this medicine. This medicine can be very
damaging to your unborn baby (embryo).
Both female and male patients must take special precautions in their sexual
activity if there is any possibility for pregnancy to occur:
• Girl or woman of childbearing age:
You must have a negative pregnancy test before treatment, each month during
treatment, and for the 4 months after treatment is stopped. This should be
discussed with your doctor.
• Men:
Do not have sex with a pregnant woman unless you use a condom. This will
lessen the possibility for ribavirin to be left in the woman's body.
If your female partner is not pregnant now but is of childbearing age, she must
be tested for pregnancy each month during treatment and for 7 months after
treatment has stopped. You and your female partner must use an effective
contraceptive during the time you are taking Ribavirin and for 7 months after
stopping the treatment. This should be discussed with your doctor (see section
“Do not take Ribavirin”).

If you are not sure, talk to your doctor or pharmacist before taking Ribavirin.
- are allergic to ribavirin or any of the other ingredients of this medicine (listed
in section 6).
- are pregnant or planning to become pregnant. (see section
“pregnancy,breast-feeding and fertility).
- are breast-feeding.
- had aserious heart problemduring the past 6 months.
- have any blood disorder, such as anaemia (low blood count), thalassemia
or sickle-cell anaemia.

If you are a woman who is breast-feeding, you must not take this medicine.
Discontinue breastfeeding before starting to take this medicine.

Children and adolescents must not take combination therapy with Ribavirin and
alpha interferon when there is existence or history of serious nervous or mental
problems, such as severe depression, suicidal thoughts or attempted suicide.

Ribavirin contains
Each Ribavirin capsule contains a small amount of lactose. If you have been
told by your doctor that you have an intolerance to some sugars, discuss with
your doctor before taking this medicine.

You should tell your doctor if you have suffered from any other serious illness in
the past.
-

Reminder: Please read the “Do not take” section of the package leaflet for
the other medicines used in combination with this medicine.

Warnings and precautionsThere are several serious adverse reactions
associated with the combination therapy of ribavirin with (peg)interferon alfa.
These include:
• Psychiatric and central nervous system effects (such as depression, suicidal
thoughts, attempted suicide and aggressive behaviour, etc.). Be sure to
seek emergency care if you notice that you are becoming depressed or
have suicidal thoughts or change in your behaviour. You may want to
consider asking a family member or close friend to help you stay alert to
signs of depression or changes in your behaviour
• Severe eye disorders
• Dental and periodontal disorders: Dental and gum disorders have been
reported in patients receiving Ribavirin in combination with (peg)interferon
alfa-2b. You should brush your teeth thoroughly twice daily and have regular
dental examinations. In addition some patients may experience vomiting. If
you have this reaction, be sure to rinse your mouth thoroughly afterwards
• Inability to achieve full adult height may occur in some children and
adolescents
• Increased hormone related to your thyroid (TSH) in children and
adolescents
Paediatric population
If you are caring for a child and your doctor decides not to defer combination
treatment with peginterferon alfa-2b or interferon alfa-2b until adulthood, it is
important to understand that this combination therapy induces a growth
inhibition that may be irreversible in some patients.
In addition these events have occurred in patients taking Ribavirin:
Haemolysis: Ribavirin can cause a break down in red blood cells causing
anaemia which may impair your heart function or worsen symptoms of heart
disease.
Pancytopenia: Ribavirin can cause a decrease in your platelet and red and
white blood cell count when used in combination with peginterferon.
Standard blood tests will be taken to check your blood, kidney and liver
function.
- Blood tests will be done regularly to help your doctor to know if this
treatment is working.
- Depending upon the results of these tests, your doctor may change/adjust
the number of hard capsules you or the child you are caring for take,
prescribe a different pack size of this medicine, and/or change the length of
time to take this treatment.
If you have or develop severe kidney or liver problems, this treatment will be
stopped.
Seek medical help immediately if you develop symptoms of a severe allergic
reaction (such as difficulty in breathing, wheezing or hives) while taking this
treatment.
Talk to your doctor if you or the child you are caring for:
• are a woman of childbearing age (see section “Pregnancy,breast-feeding
and fertility”)
• are a male and your female partner is of childbearing age (see section
“Pregnancy, breastfeeding and fertility”)
• had a previous serious heart condition or have heart disease
• have another liver problem in addition to hepatitis C infection.
• have problems with your kidneys


have HIV (human immunodeficiency virus) or have ever had any other
problems with your immune system.

Please refer to the Package Leaflet of (peg)interferon alfa for more detailed
information on these safety issues.
-

Reminder: Please read the “ Warnings and precautions” section of the
Package Leaflet for the other medicines used in combination with Ribavirin
before you begin combination treatment.

Use in children and adolescents
If the child is weighing less than 47 kg or unable to swallow an oral solution of
ribavirin is available.
Other medicines and Ribavirin
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
-

-

azathioprine is a medicine that suppresses your immune system, using this
medicine in combination with ribavirin may increase your risk of developing
severe blood disorders.
anti- Human Immunodeficiency Virus (HIV) medicines– [nucleoside
reverse transcriptase inhibitor (NRTI), and/or combined anti-retroviral
therapy (cART)]:
- Taking this medicine in combination with an alpha interferon and an antiHIV medicine may increase the risk of lactic acidosis, liver failure, and

Driving and using machines
This medicine does not affect your ability to drive or use machines; however,
other medicines used in combination with Ribavirin Aurobindo may affect your
ability to drive or use machines.
Therefore, do not drive or use machines if you become tired, sleepy, or are
confused from this treatment.

3. How to take Ribavirin
General information about taking this medicine:
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist, if you are not sure.
Do not take more than the recommended dosage and take the medicine for as
long as prescribed.
Your doctor has determined the correct dose of this medicine based on how
much you or the child you are caring for weighs.
Adults
The recommended dose and duration of Ribavirin depends on how much the
patient weighs and the medicines that are used in combination.
Use in children and adolescents
Dosing for children above 3 years of age and adolescents depends on how
much the person weighs and the medicines that are used in combination. The
recommended dose of Ribavirin combined with interferon alfa-2b, is shown in
the below table.
Ribavirin based on body weight when used in combination with
interferon alfa-2b in children above 3 years of age and adolescents
If the child/
adolescent
weighs (kg)

Usual daily Ribavirin
dose

Number of 200 mg capsules

47 – 49

600 mg

1 capsule in the morning and
2 capsules in the evening

50 – 65

800 mg

> 65

2 capsules in the morning
and 2 capsules in the evening
see adult dose

Take your prescribed dose by mouth with water and during your meal. Do not
chew the hard capsules. For children or adolescents who cannot swallow a hard
capsule, an oral solution of this medicine is available.
Reminder: This medicine is used in combination with other medicines for
hepatitis C virus infection. For complete information be sure to read the “How to
use” section of the Package Leaflet for the other medicines used in combination
with Ribavirin.
If you take more Ribavirin than you should
Tell your doctor or pharmacist as soon as possible.
If you forget to take Ribavirin
Take/administer the missed dose as soon as possible during the same day. If an
entire day has gone by, check with your doctor. Do not take a double dose to
make up for a forgotten dose.
4. Possible side effects
Please read the “Possible side effects” section of the Package Leaflet for the
other medicines used in combination with Ribavirin.
Like all medicines, this medicine used in combination with other medicines can
cause side effects, although not everybody gets them. Although not all of these
unwanted effects may occur, they may need medical attention if they do occur.
• severe stomach pain
• black or tar-like stools
• blood in stool or urine
• severe bleeding from your nose
• fever or chills beginning after a few weeks of treatment
• lower back or side pain
• painful or difficult urination
• problems with your eyesight or hearing,
• severe skin rash or redness
Contact your doctor immediately if you notice any of the following side effects
occurring during combination treatment with other medicines:
− chest pain or persistent cough; changes in the way your heart beats,
fainting,
− confusion, feeling depressed; suicidal thoughts or aggressive behaviour,
attempt suicide, thoughts about threatening the life of others,
− feelings of numbness or tingling,
− trouble sleeping, thinking or concentrating,
− severe stomach pain, black or tar-like stools, blood in stool or urine, lower
back or side pain,
− painful or difficult urination,
− severe bleeding from your nose,
− fever or chills beginning after a few weeks of treatment,
− problems with your eyesight or hearing,
− severe skin rash or redness.
The following side effects have been reported with the combination of this
medicine hard capsules and an alpha interferon product in adults:

Very commonly reported side effects (may affect more than 1 in 10 people):
− decreases in the number of red blood cells (that may cause fatigue,
shortness of breath, dizziness), decrease in neutrophils (that make you
more susceptible to different infections).
− difficulty concentrating, feeling anxious or nervous, mood swings, feeling
depressed or irritable, tired feeling, trouble falling asleep or staying asleep,
− cough, dry mouth, pharyngitis (sore throat)
− diarrhoea, dizziness, fever, flu-like symptoms, headache, nausea, shaking
chills, virus infection, vomiting, weakness,
− loss of appetite, loss of weight, stomach pain,
− dry skin, irritation, hair loss, itching, muscle pain, muscle aches, pain in
joints and muscles, rash.
Commonly reported side effects (may affect up to 1 in 10 people):
− decrease in blood clotting cells called platelets that may result in easy
bruising and spontaneous bleeding, decrease in certain white blood cells
called lymphocytes that help fight infection, decrease in thyroid gland activity
(which may make you feel tired, depressed, increase your sensitivity to cold
and other symptoms) excess of sugar or uric acid (as in gout) in the blood,
low calcium level in the blood, severe anaemia
− fungal or bacterial infections, crying, agitation, amnesia, memory impaired,
nervousness, abnormal behaviour, aggressive behaviour, anger, feeling
confused, lack of interest, mental disorder, mood changes, unusual dreams,
wanting to harm yourself, feeling sleepy, trouble sleeping, lack of interest in
sex or inability to perform, vertigo (spinning feeling)
− blurred or abnormal vision, eye irritation or pain or infection, dry or teary
eyes, changes in your hearing or voice, ringing in ears, ear infection,
earache, cold sores (herpes simplex), change in taste, taste loss, bleeding
gums or sores in mouth, burning sensation on tongue, sore tongue, inflamed
gums, tooth problem, migraine, respiratory infections, sinusitis, nose bleed,
nonproductive cough, rapid or difficult breathing, stuffy or runny nose, thirst,
tooth disorder,
− cardiac murmur (abnormal heart beat sounds), chest pain or discomfort,
feeling faint, feeling unwell, flushing, increased sweating, heat intolerance
and excessive sweating, low or high blood pressure, palpitations (pounding
heart beat), rapid heart rate.
− bloating, constipation, indigestion intestinal gas (flatus), increased appetite,
irritated colon, irritation of prostate gland, jaundice (yellow skin), loose
stools, pain on the right side around your ribs, enlarged liver, stomach upset,
frequent need to urinate, passing more urine than usual, urinary tract
infection, abnormal urine,
− difficult, irregular, or no menstrual period, abnormally heavy and prolonged
menstrual periods, painful menstruation, disorder of ovary or vagina, breast
pain, erectile problem,
− abnormal hair texture, acne, arthritis, bruising, eczema (inflamed, red, itchy
and dryness of the skin with possible oozing lesions),hives, increased or
decreased sensitivity to touch, nail disorder, muscle spasms, numbness or
tingling feeling, limb pain, pain at the site of injection, pain in joints, shaky
hands, psoriasis, puffy or swollen hands and ankles, sensitivity to sunlight,
rash with raised spotted lesions, redness of skin or skin disorder, swollen
face, swollen glands (swollen lymph nodes), tense muscles, tumour
(unspecified), unsteady when walking, water impairment.
Uncommonly reported side effects (may affect up to 1 in 100 people):
− hearing or seeing images that are not present,
− heart attack, panic attack,
− hypersensitivity reaction to the medication,
− inflammation of pancreas, pain in bone, diabetes mellitus,
− muscle weakness.
Rarely reported side effects(may affect up to 1 in 1,000 people):
− seizure (convulsions)
− pneumonia,
− rheumatoid arthritis, kidney problems,
− dark or bloody stools, intense abdominal pain
− sarcoidosis (a disease characterised by persistent fever, weight loss, joint
pain and swelling, skin lesions and swollen glands),
− vasculitis.
Very rarely reported side effects (may affect up to 1 in 10,000 people):
− suicide.
− stroke (cerebrovascular events)
Not known side effects (frequency cannot be estimated from the available data):
− thoughts about threatening the life of others,
− mania (excessive or unreasonable enthusiasm),
− pericarditis (inflammation of the lining of the heart), pericardial effusion [a
fluid collection that develops between the pericardium (the lining of the
heart) and the heart itself.
- change in colour of the tongue
Side effects in children and adolescents
The following side effects have been reported with the combination of this
medicine and an interferon alfa-2b product in children and adolescents:
Very commonly reported side effects (may affect more than 1 in 10 people):
− decreases in the number of red blood cells (that may cause fatigue,
shortness of breath, dizziness) decrease in neutrophils (that make you more
susceptible to different infections),
− decrease in thyroid gland activity (which may make you feel tired,
depressed, increase your sensitivity to cold and other symptoms),
− feeling depressed or irritable, feeling sick to stomach, feeling unwell, mood
swings, tired feeling, trouble falling asleep or staying asleep, virus infection,
weakness,
− diarrhoea, dizziness, fever, flu-like symptoms, headache, loss of or increase
in appetite, loss of weight, decrease in the rate of growth (height and
weight), pain on right side of ribs, pharyngitis (sore throat), shaking chills,
stomach pain, vomiting,
− dry skin, hair loss, irritation, itching, muscle pain, muscle aches, pain in
joints and muscles, rash.
Commonly reported side effects (may affect up to 1 in 10 people):
− decrease in blood clotting cells called platelets (that may result in easy
bruising and spontaneous bleeding),
− excess of triglycerides in the blood, excess of uric acid (as in gout) in the
blood, increase in thyroid gland activity (which may cause nervousness,
heat intolerance and excessive sweating, weight loss, palpitation, tremors),
− agitation, anger, aggressive behaviour, behaviour disorder, difficulty
concentrating, emotional instability, fainting, feeling anxious or nervous,
feeling cold, feeling confused, feeling of restlessness, feeling sleepy, lack of
interest or attention, mood changes, pain, poor quality sleep, sleepwalking,
suicide attempt, trouble sleeping, unusual dreams, wanting to harm yourself,
− bacterial infections, common cold, fungal infections, abnormal vision, dry or
teary eyes, ear infection, eye irritation or pain or infection, change in taste,
changes in your voice, cold sores, coughing, inflamed gums, nose bleed,
nose irritation, oral pain, pharyngitis (sore throat), rapid breathing,
respiratory infections, scaling lips and clefts in the corners of the mouth,
shortness of breath, sinusitis, sneezing, sores in mouth, sore tongue, stuffy
or runny nose, throat pain, toothache, tooth abscess, tooth disorder, vertigo
(spinning feeling), weakness
− chest pain, flushing, palpitations (pounding heart beat), rapid heart rate,
− abnormal liver function,
− acid reflux, back pain, bedwetting, constipation, gastroesophageal or rectal
disorder, incontinence, increased appetite, inflammation of the membrane of
the stomach and intestine, stomach upset, loose stools,
− urination disorders, urinary tract infection,
− difficult, irregular or no menstrual period, abnormally heavy and prolonged
menstrual periods, disorder of vagina, inflammation of the vagina, testis
pain, development of male body traits,
− acne, bruising, eczema (inflamed, red, itchy and dryness of the skin with
possible oozing lesions), increased or decreased sensitivity to touch,
increased sweating, increase in muscle movement, tense muscle, irritation
or itching at the site of injection, limb pain, nail disorder, numbness or
tingling feeling, pale skin, rash with raised spotted lesions, shaky hands,
redness of skin or skin disorder, skin discolouration, skin sensitive to
sunlight, skin wound, swelling due to a build-up of excess water, ,swollen
glands (swollen lymph nodes), tremor, tumour (unspecified).






low blood pressure,
enlarged liver,
painful menstruation,
itchy anal area (pinworms or ascarids), blistering rash (shingles), decreased
sensitivity to touch, muscle twitching, pain in skin, paleness, peeling of skin,
redness, swelling.

The attempt to harm yourself has also been reported in adults, children, and
adolescents.
This medicine in combination with an alpha interferon product may also cause:
− aplastic anaemia, pure red cell aplasia (a condition where the body stopped
or reduced the production of red blood cells); this causes severe anaemia,
symptoms of which would include unusual tiredness and a lack of energy,
− delusions
− upper and lower respiratory tract infection,
− inflammation of the pancreas,
− severe rashes which may be associated with blisters in the mouth, nose,
eyes and other mucosal membranes (erythema multiforme, Stevens
Johnson syndrome), toxic epidermal necrolysis (blistering and peeling of the
top layer of skin),
The following other side effects have also been reported with the combination of
this medicine and an alpha interferon product:
− abnormal thoughts, hearing or seeing images that are not present, altered
mental status, disorientation,
− angioedema (swelling of the hands, feet, ankles, face, lips, mouth, or throat
which may cause difficulty in swallowing or breathing),
− Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder
affecting the eyes, skin and the membranes of the ears, brain and spinal
cord)
− bronchoconstriction and anaphylaxis (a severe, whole-body allergic
reaction), constant cough,
− eye problems including damage to the retina, obstruction of the retinal
artery, inflammation of the optic nerve, swelling of the eye and cotton wool
spots (white deposits on the retina),
− enlarged abdominal area, heartburn, trouble having bowel movement or
painful bowel movement,
− acute hypersensitivity reactions including urticaria (hives), bruises, intense
pain in a limb, leg or thigh pain, loss of range of motion, stiffness,
sarcoidosis, (a disease characterised by persistent fever, weight loss, joint
pain and swelling, skin lesions and swollen glands)
This medicine in combination with peginterferon alfa-2b or interferon alfa-2b
may also cause:
− dark, cloudy or abnormally coloured urine.
− difficulty breathing, changes in the way your heart beats, chest pain, pain
down left arm, jaw pain,
− loss of consciousness,
− loss of use, drooping or loss of power of facial muscles, loss of feeling
sensation,
− loss of vision,
You or your caregiver should call your doctor immediately if you have any
of these symptoms.
If you are a HCV/HIV co-infected adult patients receiving anti-HIV treatment, the
addition of this medicine in and peginterferon alfamay increase your risk of
worsening liver function (combined anti-retroviral therapy (cART)) and increase
your risk of lactic acidosis, liver failure and blood abnormalities development
(reduction in number of red blood cells which carry oxygen, certain white blood
cells that fight infection, and blood clotting cells called platelets) (NRTI).
In HCV/HIV co-infected patients receiving cART, the following other side effects
have occurred with the combination of ribavirin hard capsules and peginterferon
alfa-2b (not listed above in adults side effects):
- appetite decreased ,
- back pain,
- CD4 lympocytes decreased,
- Defective metabolism of fat,
- Hepatitis,
- Limb pain,
- Oral candidiasis (oral thrush),
- Various laboratory blood values abnormalities.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly via the national reporting system listed in Yellow Card
Scheme Website: 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 Ribavirin
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/blister after EXP. The expiry date refers to the last date 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 Ribavirin contains
- The active substance is ribavirin.
Each Ribavirin capsule contains 200 mg of ribavirin.
-

The other ingredients are cellulose, microcrystalline, lactose monohydrate,
povidone, magnesium stearate.
The capsule shell contains gelatine, titanium dioxide (E171) and sodium
lauryl sulphate.
The capsule shell imprint contains shellac, propylene glycol, potassium
hydroxide, black iron oxide (E 172).

What Ribavirin looks like and contents of the pack
Capsule, hard
White / White, size '1' hard gelatin capsules filled with white to off-white granular
powder and imprinted with 'E' on white cap and '81' on white body with black
ink.
Ribavirin is available in PVC/PE/PVDC/Aluminium blisters and HDPE
containers in the pack sizes of
PVC/PE/PVDC/aluminium blister: 84, 112, 140 and 168 capsules
HDPE bottle: 42 and 500 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This leaflet was last revised in 02/2016.

P15XXXXX

Uncommonly reported side effects (may affect up to 1 in 100 people):
− abnormal behaviour, emotional disorder, fear, nightmare,
− bleeding of the mucous membrane that lines the inner surface of the eyelids,
blurred vision,
drowsiness, intolerance to light, itchy eyes, facial pain, inflamed gums,
− chest discomfort, difficult breathing, lung infection, nasal discomfort,
pneumonia, wheezing,

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