Botox

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Botulinum toxin type A 50 U
Available from:
Allergan New Zealand Ltd
INN (International Name):
Botulinum toxin type A 50 U
Dosage:
50 U
Pharmaceutical form:
Powder for injection
Composition:
Active: Botulinum toxin type A 50 U Excipient: Albumin Sodium chloride
Units in package:
Vial, glass, 50 U
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Allergan Inc
Therapeutic indications:
· For the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month with headache lasting 4 hours a day or longer, of which at least 8 days are with migraine)
Product summary:
Package - Contents - Shelf Life: Vial, glass, - 50 U - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze). Single use only
Authorization number:
TT50-4995b
Authorization date:
2012-01-31

BOTOX

®

Botulinum Toxin Type A injection NZ CMI v11.0, DS v13.0 Page 1 of 9

CONSUMER MEDICINE INFORMATION

BOTOX

®

(botulinum toxin, type A) purified neurotoxin complex

The information in this leaflet is ONLY a summary and is not a complete statement about BOTOX

®

injection. Your

doctor has more detailed information relating to you, your medical history and the product and should be consulted

so that you will be informed about all aspects of BOTOX

®

injection as it relates to you.

Please read this leaflet carefully before receiving BOTOX

®

injection and keep this leaflet handy as

you may want to refer to it in the future. If you have any concerns about receiving this medicine,

ask your doctor.

All medicines have benefits and risks. Your doctor has weighed the risks of using BOTOX

injection

against the benefits expected from using it for you.

1. PRODUCT DESCRIPTION

What is BOTOX

®

injection?

The injection contains a muscle relaxant obtained from the bacterium

Clostridium botulinum.

What is in BOTOX

®

injection?

Each vial contains either 50 units (U),100 units (U) or 200 units (U) of

Clostridium botulinum

toxin type

A-haemagglutinin complex as the active ingredient. It also contains human albumin and sodium chloride.

What it looks like

The injection is supplied as a sterile white vacuum-dried powder in a clear glass vial. It is diluted before

use with 0.9% sterile non-preserved sodium chloride injection.

2. WHAT BOTOX

®

INJECTION IS USED FOR

How BOTOX

®

injection works

BOTOX

works by temporarily relaxing overactive or spastic (contracting) muscles.

BOTOX

injection can also block signals to the sweat glands thus reducing excessive sweating

(hyperhidrosis), and can also block the release of chemicals in the brain associated with the cause of pain

(chronic migraine). When injected into the bladder wall, BOTOX

works on the bladder muscle to

prevent leakage of urine (urinary incontinence).

It is used to treat medical conditions associated with overactive muscles:

causing excessive eyelid blinking (blepharospasm) in patients twelve years and over

of the face (hemifacial spasm and VIIth nerve disorders)

causing “lazy eye” or squint (strabismus)

causing the head to be in an unusual posture or pain in the neck associated with twisting of the

head (cervical dystonia) in adults

CONTENTS

This leaflet answers some common questions about

1. Product description

2. What BOTOX

injection is used for

3. What to be careful of

4. How to use BOTOX

injection

5. Side effects

6. Storage and disposal

7. Further information

BOTOX

®

Botulinum Toxin Type A injection NZ CMI v11.0, DS v13.0 Page 2 of 9

in children aged two years and older, causing altered and unnatural position or movements in the

hand and arm as well as legs, including those muscles that cause abnormal ankle position and

walking gait (juvenile cerebral palsy)

in adults, causing focal spasticity in the hands, arms or legs (adult focal spasticity).

BOTOX

is also used:

to treat overactive bladder with leakage of urine (urinary incontinence), the sudden urge to empty

your bladder and needing to go to the toilet more than usual when another drug (called an

anticholinergic) did not help. BOTOX

has been shown to markedly reduce leakage of urine and

improve the quality of life of patients suffering from leakage of urine due to overactive bladder.

to treat leakage of urine (urinary incontinence) in adults with bladder problems due to neurologic

disease . BOTOX

has been shown to markedly reduce leakage of urine and improve the quality

of life of patients suffering from leakage of urine due to neurogenic bladder.

to treat headaches occurring in adults with chronic migraine

to treat excessive sweating from the armpit area.

to improve the look of vertical frown lines that appear between the eyebrows, lines around the

eyes and on the forehead.

Availability

The Ministry of Health has approved BOTOX

injection for the uses listed above. However, your doctor

may use this medicine for another purpose. If you want more information, ask your doctor.

3. WHAT TO BE CAREFUL OF

BOTOX

injection must not be used if:

you are allergic to any of the ingredients listed in section 1 (Product Description)

you have an infection in the muscles where it would normally be injected.

you have any muscle disorders in other parts of your body, such as myasthenia gravis or Eaton

Lambert Syndrome .

you have a sudden onset of urinary tract infection (UTI) for patients being treated for urinary

incontinence

you have a sudden inability to empty your bladder (and are not regularly using a catheter) for patients

being treated for urinary incontinence

the container is damaged or shows signs of tampering, or if the product does not look quite right.

Tell your doctor if:

you have any muscle disorders in other parts of your body, including amyotrophic lateral sclerosis

you are taking or are likely to take antibiotics, especially aminoglycoside antibiotics you are taking

anti-platelets (aspirin-like products) and/or anti-coagulants (blood thinners)

you are being treated for leakage of urine and are not willing and/or able

to begin using a

catheter if required

you are scheduled to have surgery using a general anaesthetic

you have inflammation or severe weakness in the muscles where BOTOX

would be injected

you have a breathing problem, such as asthma or emphysema

you have swallowing problems

you have bleeding problems

you are pregnant or have the intention of becoming pregnant

you are breast feeding or planning to start breast feeding

you have ever had facial surgery

you have drooping eyelids

you have any other change in the way your face normally looks

you have angle closure glaucoma

you have problems with your heart or circulation

you are taking medicines that may interfere with muscle function

you have had seizures.

BOTOX

®

Botulinum Toxin Type A injection NZ CMI v11.0, DS v13.0 Page 3 of 9

In these circumstances it may not be possible to use BOTOX

Tell your doctor if you have problems swallowing, speaking, or breathing. These problems can happen

hours to weeks after an injection of BOTOX

usually because the muscles that you use to breathe and

swallow can become weak after the injection

Swallowing problems may last for several months. People who already have swallowing or breathing

problems before receiving BOTOX

have the highest risk of getting these problems.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you get without a prescription

from your pharmacy, supermarket or health food shop. Some medicines and BOTOX

may interfere with

each other.

Especially tell your doctor if you:

have received any other botulinum toxin product in the last four months

have recently received an antibiotic by injection

take muscle relaxants

take an allergy or cold medicine

take a sleep medicine.

4. HOW TO USE BOTOX

®

INJECTION

BOTOX injection should only be administered by a doctor familiar with the required technique. It must

be dissolved in sterile non-preserved saline solution immediately before use, and should not be used in

higher doses or more frequently than recommended.

The usual dosage of BOTOX

is as follows:

For leakage of urine due to overactive bladder

Dosage

Your doctor will give multiple injections into the bladder wall via a specific instrument (cystoscope). The

total dose is 100 U of BOTOX

. You may be given a local anaesthetic before the injections (your bladder

would be filled with anaesthetic solution for a while and then drained). You may also be given a sedative.

Duration of treatment effect

You will usually see an improvement within 2 weeks after the injection.

Typically the effect lasts 5 – 6 months after the injection.

When the effects start to wear off, you can have the treatment again if needed, but not more often than

every 3 months.

For leakage of urine due to bladder problems associated with spinal cord injury or multiple

sclerosis

Dosage

Your doctor will give multiple injections into the bladder wall via a specific instrument (cystoscope). The

total dose is 200 U of BOTOX

. You may be given a local or general anaesthetic before the injections.

You may also be given a sedative.

BOTOX

®

Botulinum Toxin Type A injection NZ CMI v11.0, DS v13.0 Page 4 of 9

Duration of treatment effect

You will usually see an improvement within 2 weeks after the injection.

Typically the effect lasts 8-10 months after the injection.

When the effects start to wear off, you can have the treatment again if needed, but not more often than

every 3 months.

Blepharospasm, Hemifacial Spasm and VIIth Nerve Disorders

The recommended dose is 1.25 U to 2.5 U (0.05 mL to 0.1 mL) for each muscle injected. The initial

effect occurs within 3 days, with the maximum muscle relaxation reached within 1-2 weeks, and lasting

approximately 3 months. After this, you should return for a repeat dose. The total maximum dose in a

two month period should not be more than 200 U.

Spasticity in children two years and older

The recommended total dose is up to 8 U/kg injected into the spastic muscles. The dose is dependent on

the size of the spastic muscle and the degree of spasticity. The dose can then be repeated, but not more

often than every 3 months.

Focal Spasticity in adults

Your doctor will determine the appropriate dose and the number of injection sites based on the number of

spastic muscles, the severity of the spasticity and the site and location of the muscles involved. Your

doctor may also tailor your dose depending on any muscle weakness that may be present and your

response to the injection. Improvement generally occurs within the first 2 weeks after injection, with

maximum effect occurring after 4-8 weeks and the effect lasting approximately 3-4 months.

In general, the total maximum dose in a 2 month period should not be more than 360 U for the treatment

of upper limb spasticity and 400 U for the treatment of lower limb spasticity in each treatment session.

Strabismus

The recommended initial dose is between 1.25 U – 2.5 U (0.05mL-0.1mL) or 2.5 U – 5.0 U (0.1mL-

0.2mL) depending on the type of strabismus you have. The initial effect occurs within 1-2 days, with the

maximum muscle relaxation reached within 1 week, and lasting approximately 2-6 weeks, then gradually

fading away over a further 2-6 weeks. You should be re-examined 1-2 weeks after the first dose. If you

need further doses once the first has worn off, you may receive up to twice the initial dose, depending

upon your response. The maximum recommended dose is 25 U per muscle per injection, with a total

maximum dose of 200 U in a two month period.

Cervical Dystonia

The recommended dose depends on the type of muscle spasm, the position of the head and neck, whether

muscle weakness is present, where pain is felt, your weight and response to the injection. Your doctor

will prescribe the proper dose for you. Improvement generally occurs within the first 2 weeks after the

injection, with the maximum effect after 6 weeks, and the effect lasting approximately 3-4 months. In

general, the total maximum dose in a 2 month period should not be more than 360 units.

Chronic Migraine

The recommended dose for treating chronic migraine is 155 U to 195 U administered intramuscularly as

0.1 ml (5 U) injections across 7 specific muscle areas in the head and neck. The dose can then be

repeated every 12 weeks.

Primary Hyperhidrosis

Recommended dosage is 50 U of BOTOX

(2.0 mL) per armpit, evenly distributed in multiple sites

approximately 1 – 2 cm apart within the armpit area. Injections should be repeated when the effects from

the previous injection wear off, but not more often than every 4 months.

BOTOX

®

Botulinum Toxin Type A injection NZ CMI v11.0, DS v13.0 Page 5 of 9

Upper Facial Lines

The recommended injection volume per injection site is 0.1 mL. However, the optimum dose levels and

number of injection sites per muscle may vary among patients. In general, the benefits obtained from

BOTOX

treatment will vary between individual people and may depend on the severity of the frown

lines.

Frown Lines

The recommended dose of BOTOX

for the treatment of glabellar lines is 20 U. This is usually injected

into the muscles around your eyebrows in 5 different places. Improvement in the severity of the lines

generally occurs within one week after the injections and has been shown to last for up to 4 months.

Crow’s Feet

The recommended dose of BOTOX

injection for the treatment of crow’s feet lines is 6-18 U per side.

This is usually injected into the muscles around your eyes, where most lines are seen when a smile is

forced, in 3 different places. Improvement in the severity of the lines generally occurs within one week

after the injections and has been shown to last for up to 4 months.

Forehead Lines

The recommended dose of BOTOX

for the treatment of forehead lines is 8-24 U. This is usually

injected into the forehead muscle in 4 different places. Improvement in the severity of the lines generally

occurs within two weeks after the injections and has been shown to last for up to 6 months.

Use in pregnancy

Use of BOTOX

when pregnant or breast-feeding is not recommended. Tell your doctor or pharmacist if

you become pregnant while being treated with BOTOX

Use in children

Use in patients below the age of 18 years has not been established for the treatment of urinary

incontinence.

Use in children below the age of 18 years has not been established for chronic migraine.

Use in children below the age of 12 has not been established for blepharospasm, strabismus, VIIth nerve

disorders, cervical dystonia, hyperhidrosis, or frown lines.

Use in children two years or older is only recommended for focal spasticity (e.g. juvenile cerebral palsy,

spasticity of the arm, hip).

Things to be careful of

Tell your doctor as soon as possible if you do not feel well while being treated with BOTOX

injection.

Be careful to resume activities gradually if you have had little exercise for a long time.

Be careful driving or operating machinery until you know how BOTOX

affects you

· If you are being treated for leakage of urine due to overactive bladder, you will be seen by your

doctor approximately 2 weeks after the injection. You will be asked to pass urine and will then have

the volume of urine left in your bladder measured using ultrasound. Your doctor will decide if you

need to return for the same test during the next 12 weeks. You must contact your doctor if at any time

you find it difficult to pass urine because it is possible that you may need to start using a catheter. In

clinical studies for patients being treated for leakage of urine due to overactive bladder,

approximately 6% of patients not using a catheter before treatment for leakage of urine needed to use

a catheter after treatment.

- If you are being treated for leakage of urine due to bladder problems associated with spinal cord

injury or multiple sclerosis, you will be seen by your doctor approximately 2 weeks after the

injection, if you were not using a catheter before the injection. You will be asked to pass urine and

will then have the volume of urine left in your bladder measured using ultrasound. Your doctor will

BOTOX

®

Botulinum Toxin Type A injection NZ CMI v11.0, DS v13.0 Page 6 of 9

decide if you need to return for the same test during the next 12 weeks. You must contact your doctor

if at any time you find it difficult to pass urine because it is possible that you may need to start using

a catheter. In clinical studies for patients being treated for leakage of urine due to neurogenic bladder,

approximately one third of patients not using a catheter before treatment for leakage of urine needed

to use a catheter after treatment.

Overdose

Telephone your doctor or National Poisons Centre on 0800 POISON (0800 764766) or go to casualty at

your nearest hospital immediately if you think that you or anyone else may have swallowed or

accidentally injected BOTOX

injection, even if there are no signs of discomfort or poisoning. You may

need to be watched for several days for signs of muscle weakness or loss of muscle movement.

Tell your doctor if you feel any general weakness, or local muscle weakness in the weeks following your

injection. There is an anti-toxin to the toxin in BOTOX

, but it is only likely to be effective if injected

within 30 minutes after the BOTOX

injection. If you have questions or concerns, or are not sure about

something, please consult your doctor or pharmacist.

5. SIDE EFFECTS

All medicines can have side effects. Sometimes they are serious, most of the time they are not. Some

patients may experience unwanted effects with BOTOX

treatment, and may need further medical

treatment. Ask your doctor to answer any questions you may have.

If while undergoing treatment with BOTOX

injection you experience any side-effects or

symptoms which may be due to this medication (whether or not it is mentioned below) please

inform your Doctor as early as possible.

This product contains albumin, an extract of human blood. Based on effective donor screening and

product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A

theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote.

No cases of transmission of viral diseases or CJD have ever been identified for albumin.

Things which may occur :

General

Pain, tenderness, inflammation, tingling or numbness, swelling, redness of the skin, infection, bleeding

and/or bruising at the site of injection, generally feeling unwell, dry eye, localised muscle

twitching/involuntary muscle contractions and weakness. The following symptoms have been reported

on rare occasions: changes in the way the heart beats, chest pain, skin rash and allergic reaction

(symptoms: shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or

other parts of the body; rash, itching or hives on the skin).

In some cases, the effect of botulinum toxin may be observed beyond the site of injection and the

following symptoms may occur:

loss of strength and muscle weakness

drooping of the upper eyelid

double or blurred vision

trouble speaking or saying words clearly

constipation

aspiration pneumonia (serious lung infection)

trouble swallowing or breathing, which can be life-threatening.

These symptoms can happen hours to weeks after injection and are more likely to occur in patients treated

with high doses or who have underlying conditions that would predispose them to these symptoms.

BOTOX

®

Botulinum Toxin Type A injection NZ CMI v11.0, DS v13.0 Page 7 of 9

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you experience

any of the above symptoms.

Injections in the bladder wall for leakage of urine due to overactive bladder

Very common side effects: urinary tract infection, painful urination after the injection*.

Common side effects: bacteria in the urine, inability to empty your bladder (urinary retention), incomplete

emptying of the bladder, frequent daytime urination, blood in the urine after the injection**.

* This side effect may also be related to the injection procedure.

**This side effect is only related to the injection procedure.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell

your doctor or pharmacist.

Injections in the bladder wall for leakage of urine due to bladder problems associated with spinal cord

injury or multiple sclerosis

Very common side effects: urinary tract infection, inability to empty your bladder (urinary retention).

Common side effects: difficulty in sleeping, constipation, muscle weakness, muscle spasm, bulge in the

bladder wall, tiredness, problems with walking, fall.

Common side effects related to the injection procedure: blood in the urine after the injection, painful

urination after the injection, possible uncontrolled reflex reaction of your body (e.g. profuse sweating,

throbbing headache or increase in pulse rate) around the time of the injection.

Blepharospasm, Hemifacial Spasm or VIIth Nerve Disorders

Drooping of the eyelids, irritation or tearing, dry eye, not being able to close the eye, sensitivity to light,

dizziness and tiredness. Less commonly, inward or outward turning of the eye, inflammation of the eye,

double vision, and swelling of the eyelid skin lasting several days.

Spasticity in children two years and older

Falling, clumsiness, leg pain, weakness of the leg, localised and generalised muscle weakness. Less

commonly, leg cramps, fever and knee or ankle pain, increased frequency of passing urine, joint

dislocation and muscle spasms.

Focal Spasticity in adults:

Most side effects that have been reported in patients being treated for focal spasticity were mild to

moderate and got better without needing medical attention. Side effects reported include: pain in the

affected limb, changes in ease of movement of the muscle, increased sensitivity to touch or pain,

headache, muscular weakness, pain at the injection site, fever, flu-like illness, joint pain, swelling of the

extremities such as the hands and feet and bruising under the skin. Less common side effects include:

fever, flu syndrome, weakness or a loss of energy, skin problems, nausea, ‘pins & needles’, itching and

lack of coordination.

Strabismus

Disorientation, double vision, or inability to focus the eyes properly, drooping of the eyelids. Less

commonly, perforations of the white of the eye during injection, bleeding inside the eye, change to the

pupil where it may become slow to react to light; but none of t

hese have resulted in loss of vision.

BOTOX

®

Botulinum Toxin Type A injection NZ CMI v11.0, DS v13.0 Page 8 of 9

Cervical Dystonia

Soreness or bruising where the injection was given, difficulty in swallowing, neck pain, weakness of the

neck, and less commonly, general weakness. Side effects, if they occur, tend to appear in the first week

after injection, and last about two weeks.

However, in rare instances, patients may have difficulty in swallowing that could persist for longer than

two weeks after injection and may develop into a more serious condition. Make sure you tell your doctor

if you experience any difficulty in swallowing.

Chronic Migraine

Loss of movement on the face, drooping of the eyelids, skin rash, itching, pain at the injection site, neck

pain, muscle pain, tenderness or weakness, muscle spasms or tightness. Less commonly, pain of skin,

pain of jaw and difficulty in swallowing.

Headache, including worsening migraine, has been also reported, usually occurring within the first month

after treatment; however, these reactions did not always reoccur with following treatments and the overall

incidence decreased with repeated treatments.

Primary Hyperhidrosis

Increase in sweating in other areas of the body, and pain at the injection site.

Frown Lines

Drooping of the eyelids, headache, face pain, redness, swelling at the injection site, bruising, skin

tightness, muscle weakness, numbness or a feeling of pins and needles or nausea were among the more

common effects reported in clinical trials. Inability to completely close the eyelid has been reported in

post-marketing experience.

Crow’s Feet

Bruising at the injection site, headache and flu-like symptoms and inability to completely close the eyelid.

Forehead Lines

Headache, bruising, drooping of the eyebrows, eyelid swelling, aching/itching forehead, nausea, feeling

of tension and flu-like symptoms.

6. STORAGE AND DISPOSAL

BOTOX

should not be used after the date marked on the label (expiry date).

KEEP ALL MEDICINES WHERE YOUNG CHILDREN CANNOT REACH THEM.

BOTOX

should be stored in the refrigerator. The injection should be given within 24 hours after

being reconstituted, and stored in a refrigerator during this time. The injection should be clear,

colourless and free from particles. Each vial is intended for use by a single individual patient.

7. FURTHER INFORMATION

If you have any further questions on your BOTOX

treatment, or are unsure of the information, please

see your doctor, who will be able to assist you.

Manufacturer/Supplier

ALLERGAN NEW ZEALAND LIMITED

Cnr Manu Tapu Drive & Joseph Hammond Place

Auckland International Airport

Mangere, Auckland 1

New Zealand

This leaflet was prepared in May 2019.

BOTOX

®

Botulinum Toxin Type A injection NZ CMI v11.0, DS v13.0 Page 9 of 9

Mark owned by Allergan, Inc

BOTOX

Botulinum Toxin Type A Data Sheet Version 13.0 CCDS Version 19.0

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35

NEW ZEALAND DATA SHEET

1.

PRODUCT NAME

BOTOX

®

(botulinum toxin type A) purified neurotoxin complex 50 units (U), 100 units (U) or 200 units

(U) powder for injection.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vial of BOTOX

injection contains either 50 units (U), 100 units (U) or 200 units (U) of botulinum

toxin type A as a haemagglutinin complex.

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

A sterile, vacuum-dried preparation. Powder for injection.

4.

CLINICAL PARTICULARS

4.1 Therapeutic indications

BOTOX

(botulinum toxin type A) purified neurotoxin complex is indicated:

for the treatment of overactive bladder with symptoms of urinary incontinence, urgency and

frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic

medication

for the treatment of urinary incontinence due to neurogenic detrusor overactivity (e.g. spinal

cord injury or multiple sclerosis) in adults who have an inadequate response to or are intolerant

of an anticholinergic medication

for the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days

per month with headache lasting 4 hours a day or longer, of which at least 8 days are with

migraine)

for the treatment of strabismus and blepharospasm associated with dystonia, including benign

essential blepharospasm or VIIth nerve disorders in patients 12 years of age and above

to reduce the subjective symptoms and objective signs of spasmodic torticollis (cervical

dystonia) in adults

treatment of focal spasticity in children two years and older

for the treatment of primary hyperhidrosis of the axillae

for the treatment of focal spasticity in adults

for the treatment of upper facial rhytides, including forehead, crow’s feet and glabellar lines.

4.2 Dose and method of administration

Route of Administration

Intramuscular injection.

Reconstituted BOTOX

is injected with the purpose of reaching the motor endplate region of the

muscle to be treated.

BOTOX

Botulinum Toxin Type A Data Sheet Version 13.0 CCDS Version 19.0

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35

May be subcutaneous for blepharospasm.

Intradermal for hyperhidrosis

of the axillae.

General

BOTOX

®

should only be given by physicians with the appropriate qualifications and experience

in the treatment of patients and the use of required equipment.

The use of one vial for more than one patient is not recommended because the product and

diluent do not contain a preservative. Once opened and reconstituted, store in the refrigerator

and use within twenty four hours. Discard any remaining solution. Do not freeze reconstituted

BOTOX

®

.

Optimum dose levels and the number of injection sites per muscle have not been established for all

indications. The exact dosage and number of injection sites should be tailored to the patient’s needs

based on the size, number and location of muscles involved, severity of the disease, presence of local

muscle weakness, response to previous treatment and the patient’s medical condition. In general,

dosing of BOTOX

should be individualised for each patient and always start with the minimal effective

dose. The dosing interval should typically not be more frequent than every three months.

Bladder Dysfunction

Patients should not have an urinary tract infection at the time of treatment. Prophylactic antibiotics

should be administered 1 - 3 days pre-treatment, on the treatment day and 1 - 3 days post-treatment.

It is recommended that patients discontinue anti-platelet therapy at least 3 days before the injection

procedure. Patients on anti-coagulant therapy need to be managed appropriately to decrease the risk of

bleeding.

Overactive Bladder

An intravesical instillation of diluted local anaesthetic with or without sedation may be used prior to

injection, as per local site practice. If a local anaesthetic instillation is performed, the bladder should be

drained and irrigated with sterile saline before injection.

The recommended dose is 100 U of BOTOX

The recommended dilution is 100 U/10 mL with 0.9% non-preserved sterile saline solution (see

DILUTION TABLE – Table 6). Dispose of any unused saline.

Reconstituted BOTOX

(100 U/10 mL) is injected into the detrusor muscle via a flexible or rigid

cystoscope, avoiding the trigone. The bladder should be instilled with enough saline to achieve

adequate visualisation for the injections but over-distension should be avoided.

The injection needle should be filled (primed) with approximately 1 mL of reconstituted BOTOX

prior to

the start of injections (depending on the needle length) to remove any air.

The needle should be inserted approximately 2 mm into the detrusor and 20 injections of 0.5 mL each

(total volume of 10 mL) should be spaced approximately 1 cm apart (see figure 1 below). For the final

injection, approximately 1 mL of sterile normal saline should be injected so the full dose is delivered.

After the injections are given, the saline used for bladder wall visualisation should not be drained so that

patients can demonstrate their ability to void prior to leaving the clinic. The patient should be observed

for at least 30 minutes post-injection and until a spontaneous void has occurred.

BOTOX

Botulinum Toxin Type A Data Sheet Version 13.0 CCDS Version 19.0

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Clinical improvement may occur within 2 weeks. Patients should be considered for re-injection when the

clinical effect of the previous injection has diminished (median duration in phase 3 clinical trials was 166

days [~24 weeks]) but no sooner than 3 months from the prior bladder injection.

Figure 1

Neurogenic Detrusor Overactivity

An intravesical instillation of diluted local anaesthetic with or without sedation, or general anaesthesia,

may be used prior to injection, as per local site practice. If a local anaesthetic instillation is performed,

the bladder should be drained and irrigated with sterile saline before injection.

The recommended dose is 200 U of BOTOX

Reconstitute two 100 U vials of BOTOX

, each with 6 mL of 0.9% non-preserved sterile saline solution

and mix the vials gently. Draw 4 mL from each vial into each of two 10 mL syringes. Draw the remaining

2 mL from each vial into a third 10 mL syringe. Complete the reconstitution by adding 6 mL of 0.9%

non-preserved sterile saline solution into each of the 10 mL syringes and mix gently. This will result in

three 10 mL syringes each containing 10 mL (~67 U in each), for a total of 200 U of reconstituted

BOTOX

. Use immediately after reconstitution in the syringe. Dispose of any unused saline.

Reconstituted BOTOX

(200 U/30 mL) is injected into the detrusor muscle via a flexible or rigid

cystoscope, avoiding the trigone. The bladder should be instilled with enough saline to achieve

adequate visualisation for the injections but over-distension should be avoided.

The injection needle should be filled (primed) with approximately 1 mL of reconstituted BOTOX

prior to

the start of injections (depending on the needle length) to remove any air.

The needle should be inserted approximately 2 mm into the detrusor and 30 injections of 1 mL (~6.7 U)

each (total volume of 30 mL) should be spaced approximately 1 cm apart (see figure 1 above). For the

final injection, approximately 1 mL of sterile normal saline should be injected so the full dose is

delivered. After the injections are given, the saline used for bladder wall visualisation should be drained.

The patient should be observed for at least 30 minutes post-injection.

Clinical improvement generally occurs within 2 weeks. Patients should be considered for re-injection

when the clinical effect of the previous injection has diminished (median duration in phase 3 clinical

trials was 256 - 295 days (36 - 42 weeks) for BOTOX

200 U) but no sooner than 3 months from the

prior bladder injection.

BOTOX

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Chronic Migraine

The recommended dose for treating chronic migraine is 155 U to 195 U administered intramuscularly

(i.m.) using a 30-gauge, 0.5 inch needle as 0.1 mL (5 U) injections per each site. Injections should be

divided across 7 specific head/neck muscle areas as specified in Table 1 below. A 1-inch needle may

be needed in the neck region for patients with extremely thick neck muscles. With the exception of the

procerus muscle, which should be injected at 1 site (midline), all muscles should be injected bilaterally

with the minimum dose per muscle as indicated below, with half the number of injection sites

administered to the left and half to the right side of the head and neck. If there is a predominant pain

location(s), additional injections to one or both sides may be administered in up to 3 specific muscle

groups (occipitalis, temporalis and trapezius), up to the maximum dose per muscle as indicated in Table

1 below.

The recommended re-treatment schedule is every 12 weeks.

Table 1: BOTOX

®

Dosing by Muscle for Chronic Migraine

Recommended Dose

Head/Neck Area

Total Number of Units (U) (number of IM injection sites

a

)

Frontalis

20 U (4 sites)

Corrugator

10 U (2 sites)

Procerus

5 U (1 site)

Occipitalis

30 U (6 sites) up to 40 U (up to 8 sites)

Temporalis

40 U (8 sites) up to 50 U (up to 10 sites)

Trapezius

30 U (6 sites) up to 50 U (up to 10 sites)

Cervical Paraspinal

Muscle Group

20 U (4 sites)

Total Dose Range:

155 U to 195 U

a

1 IM injection site = 0.1 mL = 5 U BOTOX

®

b

Dose distributed bilaterally for minimum dose

Cervical Dystonia (spasmodic torticollis)

Dosing must be tailored to the individual patient based on the patient's head and neck position,

localisation of pain, muscle hypertrophy, patient's bodyweight and patient response.

Multiple injection sites allow BOTOX

to have more uniform contact with the innervation areas of the

dystonic muscle and are especially useful in larger muscles. The optimal number of injection sites is

dependent upon the size of the muscle to be chemically denervated. The treatment of cervical dystonia

typically may include, but is not limited to, injection of BOTOX

into the sternocleidomastoid, levator

scapulae, scalene, splenius capitis and/or the trapezius muscle(s).

A 25, 27 or 30 gauge needle should be used for superficial muscles and a needle of appropriate length

may be used for deeper musculature. For cervical dystonia, localisation of the involved muscles with

electromyographic guidance may be useful.

Table 2 below is intended to provide dosing guidelines for injection of BOTOX

in the treatment of

cervical dystonia.

BOTOX

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Table 2: Dosage Guide

Classification of

Cervical Dystonia

Muscle Groupings

Total Dosage;

Number of Sites

Type I

Head rotated toward

side of shoulder

elevation

Sternocleidomastoid

Levator scapulae

Scalene

Splenius capitis

Trapezius

50 - 100 U; at least 2 sites

50 U; 1 - 2 sites

25 - 50 U; 1 - 2 sites

25 - 75 U; 1 - 3 sites

25 - 100 U; 1 - 8 sites

Type II

Head rotation only

Sternocleidomastoid

25 - 100 U; at least 2 sites if >25 U

given

Type III

Head tilted toward

side of shoulder

elevation

Sternocleidomastoid

Levator scapulae

Scalene

Trapezius

25 - 100 U; at posterior border; at

least 2 sites if >25 U given

25 - 100 U; at least 2 sites

25 - 75 U; at least 2 sites

25 - 100 U; 1 - 8 sites

Type IV

Bilateral posterior

cervical muscle

spasm with elevation

of the face

Splenius capitis and

cervicis

50 - 200 U; 2 - 8 sites, treat

bilaterally

This information is provided as guidance for initial injection. The extent of muscle hypertrophy and the

muscle groups involved in the dystonic posture may change with time, necessitating alterations in the

dose of toxin and muscles to be injected. The exact dose and sites injected must be individualised for

each patient.

Table 3 below shows the median dose of BOTOX

injected per muscle in a clinical trial in which dose

was determined by the practitioner based on the presentation of the individual cervical dystonia patient.

Table 3: BOTOX

®

Dosing by Muscle for Cervical Dystonia

Muscle(s)

Range of Medians*

(U)

Minimum - Maximum

Dose, U/muscle**

Sternocleidomastoid

15 - 190

Trapezius

50 - 60

5 - 200

Levator scapulae

10 - 180

Splenius capitis/cervicis

10 - 240

Scalene

5 - 90

* Two medians were given: for those patients who received one injection cycle (n = 121) and for those patients who received

two injection cycles (n = 90). When only one number is given, the medians were the same for both groups of patients.

** Limiting the dose injected into the sternocleidomastoid muscle to less than 100 U may decrease the occurrence of

dysphagia (see SPECIAL WARNINGS AND PRECAUTIONS FOR USE).

In initial controlled clinical trials to establish safety and efficacy for cervical dystonia, doses of BOTOX

ranged from 140 to 280 U. In more recent trials, the doses have ranged from 95 to 360 U (with an

approximate mean of 240 U). As with any medicinal treatment, initial dosing should begin at the lowest

effective dose.

In general, a total dose of 360 U every two months should not be exceeded for the treatment of cervical

dystonia. The time-to-retreatment will vary between patients, however data from controlled clinical trials

indicates that symptoms may start to re-emerge at approximately 8-10 weeks post-injection. Clinical

improvement generally occurs within the first two weeks after injection. The maximum clinical benefit

BOTOX

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generally occurs approximately six weeks post-injection. The duration of therapeutic effect reported in

clinical trials showed substantial variation (from 2 to 32 weeks), with a typical duration of approximately

12 to 16 weeks, depending on the patient's individual disease and response.

Repeat doses should be administered when the clinical effect of a previous injection diminishes, though

usually not more frequently than every two months. “Booster” injections are not recommended.

Strabismus

BOTOX

is intended for injection into extraocular muscles utilising the electrical activity recorded from

the tip of the injection needle as a guide to placement within the target muscle. Injection without

surgical exposure or electromyographic guidance should not be attempted. Physicians should be

familiar with electromyographic techniques.

An injection of BOTOX

is prepared by drawing into a sterile tuberculin syringe an amount of the

properly diluted toxin (see DILUTION TABLE – Table 6) slightly greater than the intended dose. Air

bubbles in the syringe barrel are expelled and the syringe is attached to the electromyographic

injection needle, preferably a one and a half inch, 27 gauge needle. Injection volume in excess of the

intended dose is expelled through the needle into an appropriate waste container to assure patency of

the needle and to confirm that there is no syringe-needle leakage. A new, sterile needle and syringe

should be used to enter the vial on each occasion for dilution or removal of BOTOX

To prepare the eye for BOTOX

injection, it is recommended that several drops of a local anaesthetic

and an ocular decongestant be given several minutes prior to injection.

NOTE: The volume of BOTOX

injected for treatment of strabismus should be between 0.05 mL to

0.15 mL per muscle.

Strabismus dosage: The initial doses of the diluted BOTOX

(see DILUTION TABLE – Table 6)

typically create paralysis of injected muscles beginning one to two days after injection and increases in

intensity during the first week. Paralysis lasts for 2 - 6 weeks and gradually resolves over a similar time

period.

Overcorrections lasting over 6 months have been rare. About one half of patients will require

subsequent doses because of inadequate paralytic response of the muscle to the initial dose because

of mechanical factors such as large deviations or restrictions or because of lack of binocular motor

fusion to stabilise the alignment.

1.

Initial doses in units (abbreviated as U)

Use the lower listed doses for treatment of small deviations. Use the larger doses only for large

deviations.

A. For vertical muscles and for horizontal strabismus of less than 20 prism diopters: 1.25 U to 2.5 U in

any one muscle.

B. For horizontal strabismus of 20 prism diopters to 50 prism diopters: 2.5 U to 5.0 U in any one muscle.

C. For persistent VIth nerve palsy of one month or longer duration: 1.25 U to 2.5 U in the medial rectus

muscle.

2.

Subsequent doses for residual or recurrent strabismus

A. It is recommended that patients be re-examined 7 - 14 days after each injection to assess the effect

of that dose.

BOTOX

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B. Patients experiencing adequate paralysis of the target muscle that require subsequent injections

should receive a dose comparable to the initial dose.

C. Subsequent doses for patients experiencing incomplete paralysis of the target muscle maybe

increased up to twice the amount of the previously administered dose.

D. Subsequent injections should not be administered until the effects of the previous dose have

dissipated as evidenced by substantial function in the injected and adjacent muscles.

E. The maximum recommended dose as a single injection for any one muscle is 25 U.

Blepharospasm

An injection of BOTOX

is prepared by drawing into a sterile 1.0 mL tuberculin syringe an amount of the

properly diluted toxin (see DILUTION TABLE – Table 6) slightly greater than the intended dose. A new,

sterile needle and syringe should be used to enter the vial on each occasion for dilution or removal of

BOTOX

For blepharospasm, diluted BOTOX

(see DILUTION TABLE – Table 6) is injected using a sterile, 27 -

30 gauge needle with or without electromyographic guidance. 1.25 U to 2.5 U (0.05 mL to 0.1 mL

volume at each site) injected into the medial and lateral pre-tarsal orbicularis oculi of the upper lid and

into the lateral pre-tarsal orbicularis oculi of the lower lid is the initial recommended dose. Pre-tarsal

injections are often appropriate and may vary based on the patient’s presentation. In the upper lid,

maximising the distance of the injection from the levator palpebrae superioris may reduce the

complication of ptosis. Avoiding medial lower lid injections, and thereby reducing diffusion into the

inferior oblique, may reduce the complication of diplopia. Ecchymosis may occur easily in the soft eyelid

tissue. This may be reduced by applying light pressure at the injection site immediately after the

injection.

In general, the initial effect of the injections is seen within three days and reaches a peak at one to two

weeks post-treatment. Each treatment lasts approximately three months, following which the

procedure can be repeated as needed.

At repeat treatment sessions, the dose may be increased up to two-fold if the response from the initial

treatment is considered insufficient - usually defined as an effect that does not last longer than two

months. However, there appears to be a minimal increase in benefit from injecting more than 5.0 U per

site.

Some tolerance may be found when BOTOX

is used in treating blepharospasm if treatments are

given any more frequently than every three months. The effect is rarely permanent.

The cumulative dose of BOTOX

in a two month period should not exceed 200 U.

VIIth Nerve Disorders

Patients with hemifacial spasm or VIIth nerve disorder should be treated as for unilateral

blepharospasm. Further injections may be necessary into the corrugator, zygomaticus major, orbicularis

oris and/or other facial muscles according to the extent of the spasm. Electromyographical control may

be useful to identify small circumoral muscles.

The cumulative dose of BOTOX

in a two month period should not exceed 200 U.

Focal Spasticity in Children two years and older

The exact dose and number of injection sites should be tailored to the child’s needs based on the size,

number and location of muscles involved, the severity of spasticity, presence of local muscle weakness

BOTOX

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and the patient’s response to previous treatment. In clinical trials the dose per muscle ranged from 0.5 -

2.0 U/kg body weight in the upper limb and 2.0 - 4.0 U/kg body weight in the lower limb per treatment

session. For the treatment of equinus foot deformity, the total dose is up to 4 U/kg or 200 U (whichever

is the lesser amount) divided into two sites in each medial and lateral head of the gastrocnemius

muscle. In other muscles the dose per muscle ranged from 3.0 - 8.0 U/kg body weight and did not

exceed 300 U divided among selected muscles at any treatment session. Following initial injection to

the gastrocnemius muscle, further involvement of the anterior or posterior tibialis may need to be

considered for additional improvement in the foot position at heel strike and during standing.

A 27 or 30 gauge needle should be used with an appropriate needle length to reach the targeted

muscles. For focal spasticity, localisation techniques include electromyography, muscle ultrasound or

electrical stimulation.

Clinical improvement generally occurs within the first two weeks after injection. Repeat doses should

be administered when the clinical effect of a previous injection diminishes but typically not more

frequently than every three months. The maximum degree of muscle spasticity at the time of re-

injection may necessitate alterations in the dose of BOTOX

and muscles to be injected.

Table 4 below is intended to give dosing guidelines for injection of BOTOX

in the treatment of focal

spasticity in children aged 2 years and older. The maximum cumulative dose should generally not

exceed 8.0 U/kg body weight and up to a maximum of 300 U divided among selected muscles at any

treatment session or in a 3 months interval.

Table 4: BOTOX

®

Dosing by Muscle for Focal Spasticity in Children

Muscles in upper limb

Dosage in U/kg/muscle

Biceps brachii

0.5 - 2.0 U

Brachialis

0.5 - 2.0 U

Brachioradialis

0.5 - 2.0 U

Flexor carpi ulnaris

0.5 - 2.0 U

Flexor carpi radialis

0.5 - 2.0 U

Pronator teres

0.5 - 2.0 U

Pronator quadratus

0.5 - 2.0 U

Flexor digitorum profundus

0.5 - 2.0 U

Flexor digitorum sublimis

0.5 - 2.0 U

Flexor pollicis longus

0.5 - 2.0 U

Flexor pollicis brevis

0.5 - 2.0 U

Opponens pollicis

0.5 - 2.0 U

Adductor pollicis

0.5 - 2.0 U

Muscles in lower limb

Dosage in U/kg/muscle

Hip adductor group (adductor longus,

adductor brevis, adductor magnus,

medial hamstrings)

4.0 U

Gastrocnemius

2.0 - 4.0 U

Focal Spasticity in Adults

The exact dosage and number of injection sites should be tailored to the individual based on the size,

number and location of muscles involved, the severity of spasticity, presence of local muscle weakness

and the patient response to previous treatment. Clinical trials support a maximum dose of 360 U divided

among selected muscles (typically in the flexor muscles of the elbow, wrist and fingers) for treating

upper limb spasticity and a maximum dose of 400 U divided among selected muscle groups for treating

adult lower limb spasticity at any treatment session. Clinical improvement in muscle tone generally

occurs within two weeks following treatment with the peak effect seen four to six weeks following

BOTOX

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treatment. In clinical trials, patients were re-injected at 12 to 16 week intervals. The degree of muscle

spasticity at the time of re-injection may necessitate alterations in the dose of BOTOX

and muscles to

be injected.

Table 5 below is intended to provide dosing guidelines for injection of BOTOX

in the treatment of focal

spasticity.

Table 5: BOTOX

®

Dosing by Muscle for Focal Spasticity in Adults

Muscle

Total Dosage;

Number of Sites

Upper Limb

Biceps brachii

100 - 200 U; up to 4 sites

Flexor digitorum profundus

15 - 50 U; 1 - 2 sites

Flexor digitorum sublimis

15 - 50 U; 1 - 2 sites

Flexor carpi radialis

15 - 60 U; 1 - 2 sites

Flexor carpi ulnaris

10 - 50 U; 1 - 2 sites

Adductor pollicis

20 U; 1 - 2 sites

Flexor pollicis longus

20 U; 1 - 2 sites

Lower Limb

Posterior tibialis

70 - 100 U; 1 - 2 sites

Soleus

80 - 125 U; 1 - 2 sites

Flexor hallucis longus

50 U; 2 sites

Flexor digitorum longus/brevis

50 - 100 U; 2 - 4 sites

Gastrocnemius medial/lateral

50 - 200 U; 2 - 4 sites

A 25, 27 or 30 gauge needle should be used with an appropriate needle length to reach the targeted

muscles. For focal spasticity, localisation techniques include electromyography, muscle ultrasound or

electrical stimulation.

Multiple injection sites may allow BOTOX

to have more uniform contact with the innervation areas of

the muscle and may be especially useful in larger muscles.

Primary Hyperhidrosis of the Axillae

The hyperhidrotic area to be injected may be defined using standard staining techniques, e.g. Minor’s

iodine-starch test. BOTOX

is reconstituted with 0.9% non-preserved sterile saline solution (100 U/4.0

mL). Using a 30 gauge needle, 50 U of BOTOX

(2.0 mL) is injected intradermally, to each axilla

evenly distributed in multiple sites approximately 1 - 2 cm apart. Each dose is injected to a depth of

approximately 2 mm and at a 45 degree angle to the skin surface with the bevel side up to minimise

leakage and ensure the injections remain intradermal.

At week 1, BOTOX

-treated patients demonstrated 95% treatment responder rate based on

gravimetric assessment. At 16 weeks, 82% of BOTOX

-treated patients were responding to treatment.

Approximately 40% of patients received only 1 treatment with BOTOX

and had a duration of effect for

over 1 year (median time 68 weeks). When patients received at least 2 consecutive treatments with

BOTOX

, the mean time to re-treatment following their first treatment was 33 weeks (range 15 to 51

weeks). Repeat injections for axillary hyperhidrosis should be administered when the effects from

previous injections subside but usually not more frequently than every two months.

Upper Facial Lines (Glabellar Lines, Crow’s Feet and Forehead Lines)

As optimum dose levels and number of injection sites per muscle may vary among patients, individual

dosing regimes should be drawn up. The recommended injection volume per injection site is 0.1 mL.

BOTOX

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Glabellar Lines

BOTOX

should be reconstituted with 0.9% non-preserved sterile saline solution (100 U/2.5 mL) and

injected using a sterile 30 gauge needle. A volume of 0.1 mL (4 U) is administered in each of 5 injection

sites, 2 injections in each corrugator muscle and 1 injection in the procerus muscle for a total dose of 20

In order to reduce the complication of ptosis, injection near the levator palpebrae superioris muscle

should be avoided, particularly in patients with larger brow-depressor complexes. Medial corrugator

injections should be placed at least 1 cm above the bony supraorbital ridge.

Improvement of the severity of glabellar lines generally occurs within one week after treatment. The

effect was demonstrated for up to 4 months.

Crow’s Feet

BOTOX

should be injected bilaterally at 3 sites in the lateral aspect of the orbicularis oculi (i.e. total of

6 injections), where most lines are seen when a smile is forced. In general, 2 - 6 U is recommended per

injection site at a 2 - 3 mm depth, for a total dose of 6 - 18 U per side.

Injections should be at least 1 cm outside the bony orbit, not medial to the vertical line through the

lateral canthus and not close to the inferior margin of the zygoma.

Forehead Lines

BOTOX

should be injected intramuscularly at each of 4 injection sites in the frontalis muscle. In

general, 2 - 6 U is recommended per injection site every 1 - 2 cm along either side of a deep forehead

crease, for a total dose of 8 - 24 U.

Injections should be at least 2 - 3 cm above the eyebrow to reduce the risk of brow ptosis.

Dilution Technique

It is good practice to perform vial reconstitution and syringe preparation over plastic-lined paper towels

to catch any spillage.

To reconstitute vacuum-dried BOTOX

injection, use sterile normal saline

without a preservative; 0.9% non-preserved, sterile sodium chloride injection is the recommended

diluent. Draw up the proper amount of diluent in the appropriate size syringe. Since BOTOX

denatured by bubbling or similar violent agitation, inject the diluent into the vial gently. Discard the vial

if a vacuum does not pull the diluent into the vial. Record the date and time of reconstitution on the

space on the label. BOTOX

should be administered within 24 hours after reconstitution in the vial.

During this time period, reconstituted BOTOX

should be stored in a refrigerator (2°C to 8°C).

Reconstituted BOTOX

should be clear, colourless to slightly yellow and free of particulate matter.

Parenteral medicines should be inspected visually for particulate matter and discolouration prior to

administration and whenever the solution and the container permit. The product and recommended

diluent do not contain a preservative and are for single use only.

For reconstitution technique for intradetrusor injections for neurogenic detrusor overactivity, please refer

to DOSE AND METHOD OF ADMINISTRATION under the sub-heading NEUROGENIC DETRUSOR

OVERACTIVITY.

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