Cleviprex (Page 4 of 4)

Storage
Leave vials in cartons until use. Clevidipine is photosensitive and storage in cartons protects against photodegradation. Protection from light during administration is not required.

Store vials refrigerated at 2-8°C (36-46°F). Do not freeze. Vials in cartons may be transferred to 25°C (77°F, USP controlled room temperature) for a period not to exceed 2 months. Upon transfer to room temperature, mark vials in cartons “This product was removed from the refrigerator on _/_/_ date. It must be used or discarded 2 months after this date or the labeled expiration date (whichever date comes first).” Do not return to refrigerated storage after beginning room temperature storage.

Handling
Maintain aseptic technique while handling Cleviprex. Cleviprex is a single-use parenteral product that contains 0.005% disodium edetate to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental contamination. However, Cleviprex can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards. Do not use if contamination is suspected. Once the stopper is punctured, use within 12 hours and discard any unused portion.

Cleviprex inhibits microbial growth for up to 12 hours, as demonstrated by test data for representative USP microorganisms, staphylococcus epidermidis and serratiamarcescens.

17 PATIENT COUNSELING INFORMATION

  • Advise patients with underlying hypertension that they require continued follow up for their medical condition, and, if applicable, encourage patients to continue taking their oral antihypertensive medication(s) as directed.
  • Advise patients to contact a healthcare professional immediately for any of the following signs of a new hypertensive emergency: neurological symptoms, visual changes, or evidence of congestive heart failure.

Manufactured by:
Fresenius Kabi Austria GmbH, Graz, Austria

Marketed by:
Chiesi USA , Inc.
Cary, NC 27518

For information call: 1-888-661-9260

CLEVIPREX® is a registered trademark of Chiesi Farmaceutici S.p.A.

US Patent 5,856,346US Patent 5,739,152

CTCP-001-0920-03-SPL-2

Package Label — Principal Display Panel — 25mg/50mL Vial Label

Package Label -- Principal Display Panel -- 25mg/50mL Vial Label
(click image for full-size original)

Package Label — Principal Display Panel — 25mg/50mL Inner Carton

Package Label -- Principal Display Panel -- 25mg/50mL Inner Carton
(click image for full-size original)

Package Label — Principal Display Panel — 25mg/50mL Outer Carton

Package Label -- Principal Display Panel -- 25mg/50mL Outer Carton
(click image for full-size original)

Package Label — Principal Display Panel — 50mg/100mL Vial Label

Package Label -- Principal Display Panel -- 50mg/100mL Vial Label
(click image for full-size original)

Package Label — Principal Display Panel — 50mg/100mL Inner Carton

Package Label -- Principal Display Panel -- 50mg/100mL Inner Carton
(click image for full-size original)

Package Label — Principal Display Panel — 50mg/100mL Outer Carton

Package Label -- Principal Display Panel -- 50mg/100mL Outer Carton
(click image for full-size original)
CLEVIPREX clevipidine emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10122-611
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLEVIDIPINE (CLEVIDIPINE) CLEVIDIPINE 0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SOYBEAN OIL
GLYCERIN
EGG PHOSPHOLIPIDS
OLEIC ACID
EDETATE DISODIUM
SODIUM HYDROXIDE
Product Characteristics
Color white (Milky) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10122-611-10 10 CARTON in 1 CARTON contains a CARTON (10122-611-01)
1 NDC:10122-611-01 1 VIAL, SINGLE-USE in 1 CARTON This package is contained within the CARTON (10122-611-10) and contains a VIAL, SINGLE-USE
1 100 mL in 1 VIAL, SINGLE-USE This package is contained within a CARTON (10122-611-01) and a CARTON (10122-611-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022156 09/15/2008
CLEVIPREX clevipidine emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10122-610
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLEVIDIPINE (CLEVIDIPINE) CLEVIDIPINE 0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SOYBEAN OIL
GLYCERIN
EGG PHOSPHOLIPIDS
OLEIC ACID
EDETATE DISODIUM
SODIUM HYDROXIDE
Product Characteristics
Color white (Milky) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10122-610-10 10 CARTON in 1 CARTON contains a CARTON (10122-610-01)
1 NDC:10122-610-01 1 VIAL, SINGLE-USE in 1 CARTON This package is contained within the CARTON (10122-610-10) and contains a VIAL, SINGLE-USE
1 50 mL in 1 VIAL, SINGLE-USE This package is contained within a CARTON (10122-610-01) and a CARTON (10122-610-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022156 09/15/2008
Labeler — Chiesi USA, Inc. (088084228)
Registrant — Chiesi USA, Inc. (088084228)

Revised: 09/2022 Chiesi USA, Inc.

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