jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs [see Use in Specific Populations (8.2)].
Infertility
Advise emales of reproductive potential that PERSERIS may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible [see Use in Specific Populations (8.3)].
Manufactured for:
Indivior Inc., North Chesterfield, VA 23235.
Powder syringe manufactured by Patheon Manufacturing Services, Greenville, NC 27834.
Liquid syringe manufactured by AMRI Global, Burlington, MA 01803.
PERSERIS™ is a trademark of Indivior UK Limited. All rights reserved.
PRINCIPAL DISPLAY PANEL
Principal Display Panel - Perseris Kit 90 mg Carton Label
NDC 12496-0090-1
once-monthly
PERSERIS™
(risperidone)
for extended-release
injectable suspension
90 mg
Liquid
Syringe
+
Mix
Powde
Syringe
1 Injection
Rx only
Sterile
Single-dose only
For abdominal subcutaneous injection only. Please read complete instructions prior to use.
Principal Display Panel - Perseris Kit 90 mg Carton Label
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PRINCIPAL DISPLAY PANEL
Principal Display Panel - Perseris Kit 90 mg Injectable Suspension Label
NDC 12496-0090-2
once-monthly
PERSERIS™
(risperidone)
for extended-release
injectable suspension
90 mg
For abdominal subcutaneous
injection only.
Please read complete
instructions prior to use.
Please see accompanying
Full Prescribing Information.
Rx only
Sterile
Single-dose only
Principal Display Panel - Perseris Kit 90 mg Injectable Suspension Label
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PRINCIPAL DISPLAY PANEL
Principal Display Panel - Perseris Kit 90 mg Delivery System Label
NDC 12496-0589-2
Delivery System
for PERSERIS™ 90 mg
For abdominal subcutaneous
injection only.
Please read complete
instructions prior to use.
Please see accompanying
Full Prescribing Information.
Rx only
Sterile
Single-dose only
Principal Display Panel - Perseris Kit 90 mg Delivery System Label
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PRINCIPAL DISPLAY PANEL
Principal Display Panel - Perseris Kit 90 mg Syringe Label
NDC 12496-0090-5
Rx only
Sterile
PERSERIS™
(risperidone)
For abdominal
subcutaneous
injection only.
90 mg
Powder
Syringe
Principal Display Panel - Perseris Kit 90 mg Syringe Label
CLOSE
PRINCIPAL DISPLAY PANEL
Principal Display Panel - Perseris Kit 90 mg Delivery System Label
NDC 12496-0589-5
Rx only
Sterile
Delivery System
for PERSERIS™ 90 mg
For abdominal
subcutaneous
injection only.
Liquid
Syringe
Principal Display Panel - Perseris Kit 90 mg Delivery System Label
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PRINCIPAL DISPLAY PANEL
Principal Display Panel - Perseris Kit 120 mg Carton Label
NDC 12496-0120-1
once-monthly
PERSERIS™
(risperidone)
for extended-release
injectable suspension
120 mg
Liquid
Syringe
+
Mix
Powder
Syringe
1 Injection
Rx only
Sterile
Single-dose only
For abdominal subcutaneous injection only. Please read complete instructions prior to use.
Principal Display Panel - Perseris Kit 120 mg Carton Label
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PRINCIPAL DISPLAY PANEL
Principal Display Panel - Perseris Kit 1 |