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1
BOTOX® Injector Training
Now you can help!
November 2004
® Marks owned by Allergan, Inc.
© 2004 Allergan, Inc., Irvine, CA 92612
2
Overview of Injector Training
• Patient preparation
• Supplies needed
• Iodine starch test
• BOTOX® reconstitution
• BOTOX® injection
Please see important safety information on slide 12.
3
Patient Preparation
• Shave underarms
• Abstain from use of over-the-counter
deodorants or antiperspirants for 24 hours
prior to treatment
• Rest comfortably without exercise, hot
beverages, etc., for approximately
30 minutes prior to treatment
Please see Important Safety Information on slide 12.
4
Supplies Needed
Reconstitution
• 0.9% nonpreserved
sterile saline only
• BOTOX® 100 units
• 20-gauge, 1½-inch
extraction needle
Iodine Starch Test
• Iodine solution
• Starch Powder
• Surgical pen
• Alcohol (to clean
area)
Injection
• 30-gauge, ½-inch
injection needle
Please see Important Safety Information on slide 12.
5
Perform the Iodine Starch Test
• Dry affected axilla
• Paint area with iodine
swab
– Be sure to cover excess
area around axilla
• Let dry
• Brush area with starch
powder
• Wait 10 minutes
Please see Important Safety Information on slide 12.
6
Perform the Iodine Starch Test
• Blue-black mark will
identify affected area
• Circle affected area with
surgical marker, then
clean area inside circle
with alcohol
Please see Important Safety Information on slide 12.
7
Perform the Iodine Starch Test
• Use a surgical pen and
standard ruler to mark injection
points:
– 1½ to 2 cm apart
– Staggered to allow for ring
effect of intradermal
injections
• Count injection points and
allocate recommended dosage
of BOTOX® solution per
injection, based on:
– 50 Units per axilla
Please see Important Safety Information on slide 12.
8
BOTOX® Reconstitution
• Be certain you’ve received actual BOTOX®
product from Allergan
– Look for holographic film on vial; “Allergan”
should appear within rainbow lines
– If you do not see rainbow lines or “Allergan”
does not appear, do not use product and
please contact Allergan, Inc., directly at
(800) 890-4345 from 8:00 a.m. to 4:00 p.m.
Pacific time.
Please see Important Safety Information on slide 12.
9
BOTOX® Reconstitution
• Using a 21-gauge, 1½ - inch length needle, draw up 4 mL of 0.9%
nonpreserved sterile saline into syringe
• Insert needle at a 45 angle and slowly inject saline into BOTOX®
vial
– Ensure vacuum is present in vial, which means sterility of vial is intact
– Do not use vial if there is no vacuum present
• Release vacuum by disconnecting syringe from reconstitution
needle (with needle remaining attached to bottle) and allowing air to
flow into vial and neutralize pressure
• Gently mix BOTOX® with saline by rotating vial; do not
invert vial
• Attach a new sterile syringe to remaining needle and draw fluid from
bottom corner of vial for full extraction; do not invert vial
• Remove reconstitution needle from syringe and attach a 30-gauge
injection needle, which is recommended needle for axillary injections
BOTOX® Must Be Properly Reconstituted With Only 0.9%
Nonpreserved Saline Solution Prior to Injecting
Please see Important Safety Information on slide 12.
10
BOTOX® Injection
• Inject at a 45° angle to skin
surface
• Bevel side up to minimize
leakage and ensure injections
remain intradermal
• A depth of approximately
2 mm
• Be sure not to inject directly
on ink mark to avoid
a permanent tattoo effect
Please see Important Safety Information on slide 12.
11
BOTOX® Injection
• Clean treated area with
alcohol
• Treatment complete
Please see Important Safety Information on slide 12.
12
Important Safety Information
BOTOX® treatment is contraindicated in the presence of infection at the proposed
injection site(s) and in individuals with known hypersensitivity to any ingredient in the
formulation. Serious and/or immediate hypersensitivity reactions have been rarely
reported. These reactions include anaphylaxis, urticaria, soft tissue edema, and
dyspnea. If such a reaction occurs, further BOTOX® injection should be discontinued
and appropriate medical therapy immediately instituted. BOTOX® should only be
diluted with 0.9% nonpreserved sodium chloride. Other diluents, including lidocaine,
should not be used for reconstitution. Individuals with peripheral motor neuropathic
diseases (eg, amyotrophic lateral sclerosis or motor neuropathy) or neuromuscular
junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should only
receive BOTOX® treatment with caution. Individuals with neuromuscular disorders
may be at increased risk of clinically significant systemic effects including severe
dysphagia and respiratory compromise from typical doses of BOTOX®. The most
frequently reported adverse events (3%-10% of patients) were injection-site pain and
hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache,
fever, neck or back pain, pruritus, and anxiety.
Please see accompanying full prescribing information or visit www.botox.com.
13
Back Up
14
Hyperhidrosis Disease Severity
Scale (HDSS)
• HDSS is a 4-point scale designed to assess
severity of hyperhidrosis in everyday clinical
practice or in clinical research and effectiveness
of hyperhidrosis treatment
• HDSS can be administered by an interviewer or
self-completed by patient
• HDSS assesses disease severity based on extent
of excessive-sweating-related impairment of daily
activities
Please see Important Safety Information on slide 12.
15
Hyperhidrosis
Disease
Severity Scale
Please see Important Safety Information on slide 12.

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botox en enfermedad de hiperhidrosis axilar.ppt

  • 1. 1 BOTOX® Injector Training Now you can help! November 2004 ® Marks owned by Allergan, Inc. © 2004 Allergan, Inc., Irvine, CA 92612
  • 2. 2 Overview of Injector Training • Patient preparation • Supplies needed • Iodine starch test • BOTOX® reconstitution • BOTOX® injection Please see important safety information on slide 12.
  • 3. 3 Patient Preparation • Shave underarms • Abstain from use of over-the-counter deodorants or antiperspirants for 24 hours prior to treatment • Rest comfortably without exercise, hot beverages, etc., for approximately 30 minutes prior to treatment Please see Important Safety Information on slide 12.
  • 4. 4 Supplies Needed Reconstitution • 0.9% nonpreserved sterile saline only • BOTOX® 100 units • 20-gauge, 1½-inch extraction needle Iodine Starch Test • Iodine solution • Starch Powder • Surgical pen • Alcohol (to clean area) Injection • 30-gauge, ½-inch injection needle Please see Important Safety Information on slide 12.
  • 5. 5 Perform the Iodine Starch Test • Dry affected axilla • Paint area with iodine swab – Be sure to cover excess area around axilla • Let dry • Brush area with starch powder • Wait 10 minutes Please see Important Safety Information on slide 12.
  • 6. 6 Perform the Iodine Starch Test • Blue-black mark will identify affected area • Circle affected area with surgical marker, then clean area inside circle with alcohol Please see Important Safety Information on slide 12.
  • 7. 7 Perform the Iodine Starch Test • Use a surgical pen and standard ruler to mark injection points: – 1½ to 2 cm apart – Staggered to allow for ring effect of intradermal injections • Count injection points and allocate recommended dosage of BOTOX® solution per injection, based on: – 50 Units per axilla Please see Important Safety Information on slide 12.
  • 8. 8 BOTOX® Reconstitution • Be certain you’ve received actual BOTOX® product from Allergan – Look for holographic film on vial; “Allergan” should appear within rainbow lines – If you do not see rainbow lines or “Allergan” does not appear, do not use product and please contact Allergan, Inc., directly at (800) 890-4345 from 8:00 a.m. to 4:00 p.m. Pacific time. Please see Important Safety Information on slide 12.
  • 9. 9 BOTOX® Reconstitution • Using a 21-gauge, 1½ - inch length needle, draw up 4 mL of 0.9% nonpreserved sterile saline into syringe • Insert needle at a 45 angle and slowly inject saline into BOTOX® vial – Ensure vacuum is present in vial, which means sterility of vial is intact – Do not use vial if there is no vacuum present • Release vacuum by disconnecting syringe from reconstitution needle (with needle remaining attached to bottle) and allowing air to flow into vial and neutralize pressure • Gently mix BOTOX® with saline by rotating vial; do not invert vial • Attach a new sterile syringe to remaining needle and draw fluid from bottom corner of vial for full extraction; do not invert vial • Remove reconstitution needle from syringe and attach a 30-gauge injection needle, which is recommended needle for axillary injections BOTOX® Must Be Properly Reconstituted With Only 0.9% Nonpreserved Saline Solution Prior to Injecting Please see Important Safety Information on slide 12.
  • 10. 10 BOTOX® Injection • Inject at a 45° angle to skin surface • Bevel side up to minimize leakage and ensure injections remain intradermal • A depth of approximately 2 mm • Be sure not to inject directly on ink mark to avoid a permanent tattoo effect Please see Important Safety Information on slide 12.
  • 11. 11 BOTOX® Injection • Clean treated area with alcohol • Treatment complete Please see Important Safety Information on slide 12.
  • 12. 12 Important Safety Information BOTOX® treatment is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any ingredient in the formulation. Serious and/or immediate hypersensitivity reactions have been rarely reported. These reactions include anaphylaxis, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs, further BOTOX® injection should be discontinued and appropriate medical therapy immediately instituted. BOTOX® should only be diluted with 0.9% nonpreserved sodium chloride. Other diluents, including lidocaine, should not be used for reconstitution. Individuals with peripheral motor neuropathic diseases (eg, amyotrophic lateral sclerosis or motor neuropathy) or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should only receive BOTOX® treatment with caution. Individuals with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical doses of BOTOX®. The most frequently reported adverse events (3%-10% of patients) were injection-site pain and hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety. Please see accompanying full prescribing information or visit www.botox.com.
  • 14. 14 Hyperhidrosis Disease Severity Scale (HDSS) • HDSS is a 4-point scale designed to assess severity of hyperhidrosis in everyday clinical practice or in clinical research and effectiveness of hyperhidrosis treatment • HDSS can be administered by an interviewer or self-completed by patient • HDSS assesses disease severity based on extent of excessive-sweating-related impairment of daily activities Please see Important Safety Information on slide 12.
  • 15. 15 Hyperhidrosis Disease Severity Scale Please see Important Safety Information on slide 12.