GLYRX-PF (Page 4 of 4)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis and Impairment of Fertility

Carcinogenesis

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Mutagenesis

Studies to evaluate the mutagenic potential of glycopyrrolate have not been conducted.

Impairment of Fertility

In reproduction studies in rats, dietary administration of glycopyrrolate resulted in diminished rates of conception in a dose-related manner. Other studies in dogs suggest that this may be due to diminished seminal secretion which is evident at high doses of glycopyrrolate.

16 HOW SUPPLIED, STORAGE AND HANDLING

GLYRX® -PF (glycopyrrolate injection) is available in:

0.2 mg/mL single-dose vials packaged in 25s (NDC 51754-6000-4)

0.4 mg/2 mL (0.2 mg/mL) single-dose vials packaged in 25s (NDC 51754-6001-4)

0.6 mg/3 mL (0.2 mg/mL) single-dose prefilled disposable syringes packaged in 10s (NDC 51754-6013-3)

1 mg/5 mL (0.2 mg/mL) single-dose prefilled disposable syringes packaged in 10s (NDC 51754-6015-3)

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Drowsiness or Blurred Vision: Inform patients that GLYRX® -PF may cause drowsiness or blurred vision. Warn patients not to operate a motor vehicle or other machinery or perform hazardous work until these issues resolve [see Warnings and Precautions (5.2)].

Heat Prostration: Inform patients that in the presence of fever, high environmental temperature and/or during physical exercise, heat prostration can occur with use of anticholinergic agents, including GLYRX® -PF (due to decreased sweating), particularly in children and the elderly. Advise patients to avoid exertion and high environmental temperature after receiving GLYRX® -PF [see Warnings and Precautions (5.3)].

Light Sensitivity: Advise patients that glycopyrrolate injection may cause sensitivity of the eyes to light and to protect their eyes from light after receiving GLYRX® -PF [see Warnings and Precautions (5.9)].

Drug Interactions: Inform patients that GLYRX® -PF may interact with other drugs. Advise patients to report to their healthcare provider the use of any other medication [see Drug Interactions (7) ].

Manufactured and Distributed by:

Logo

Exela Pharma Sciences, LLC

Lenoir, NC 28645

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- 3 mL Syringe Label

3 mL Syring Label
(click image for full-size original)

NDC 51754-6013-1 Rx only

GLYRX® -PF

Glycopyrrolate Injection 0.6 mg/3 mL

(0.2 mg/mL)

3 mL Single Dose prefilled syringe. Discard Unused Portion. For IM or IV Use.

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- 3 mL Syringe Carton

3 mL Syring Carton
(click image for full-size original)

NDC 51754-6013-3 Rx only

GLYRX® -PF

Glycopyrrolate Injection

0.6 mg/3 mL (0.2 mg/mL)

For Intravenous or Intramuscular Use

10 x 3 mL Single Dose Prefilled Syringes

Discard Unused Portion

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-5 mL Syringe Label

5 mL Syringe Label
(click image for full-size original)

NDC 51754-6015-1 Rx Only

GLYRX® -PF

Glycopyrrolate Injection 1 mg/5 mL

(0.2 mg/mL)

5 mL Single Dose prefilled syringe. Discard Unused Portion.

For IM or IV Use.

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- 5 mL Syringe Carton

5 mL Syringe Carton
(click image for full-size original)

NDC 51754-6015-3 Rx Only

GLYRX® -PF

Glycopyrrolate Injection

1 mg/5 mL (0.2 mg/mL)

For Intravenous or Intramuscular Use

10 x 5 mL Single Dose Prefilled Syringes

Discard Unused Portion

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- 1 mL Vial Label

1 mL Vial Label
(click image for full-size original)

Rx Only NDC 51754-6000-1

GLYRX-PF

Glycopyrrolate Injection

0.2 mg/mL

For Intravenous or Intramuscular Use

1 mL Single Dose Vial

Discard Unused Portion

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- 1 mL Carton

1 mL Carton
(click image for full-size original)

Rx Only NDC 51754-6000-4

GLYRX-PF

Glycopyrrolate Injection

0.2 mg/mL

For Intravenous or Intramuscular Use

25 x 1 mL Single Dose Vials

Discard Unused Portion

Exela Pharma Sciences, LLC

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-2 mL Vial Label

2 mL Vial
(click image for full-size original)

Rx Only NDC 51754-6001-1

GLYRX-PF

Glycopyrrolate Injection

0.4 mg/2 mL (0.2 mg/mL)

For Intravenous or Intramuscular Use

2 mL Single Dose Vial

Discard Unused Portion

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- 2 mL Vial Carton

2 mL Carton
(click image for full-size original)

Rx Only NDC 51754-6001-4

GLYRX-PF

Glycopyrrolate Injection

0.4 mg/2 mL

For Intravenous or Intramuscular Use

25 x 2 mL Single Dose Vials

Discard Unused Portion

Exela Pharma Sciences, LLC

GLYRX-PF
glycopyrrolate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51754-6015
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51754-6015-3 10 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC
1 5 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (51754-6015-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210997 06/01/2020
GLYRX-PF
glycopyrrolate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51754-6000
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51754-6000-4 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (51754-6000-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210997 08/01/2018
GLYRX-PF
glycopyrrolate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51754-6001
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51754-6001-4 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (51754-6001-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210997 08/01/2018
GLYRX-PF
glycopyrrolate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51754-6013
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51754-6013-3 10 SYRINGE, PLASTIC in 1 CARTON contains a SYRINGE, PLASTIC
1 3 mL in 1 SYRINGE, PLASTIC This package is contained within the CARTON (51754-6013-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210997 06/01/2020
Labeler — Exela Pharma Sciences, LLC (831274399)
Establishment
Name Address ID/FEI Operations
Exela Pharma Sciences, LLC 831274399 MANUFACTURE (51754-6015), MANUFACTURE (51754-6000), MANUFACTURE (51754-6001), MANUFACTURE (51754-6013), LABEL (51754-6015), LABEL (51754-6000), LABEL (51754-6001), LABEL (51754-6013), ANALYSIS (51754-6015), ANALYSIS (51754-6000), ANALYSIS (51754-6001), ANALYSIS (51754-6013), PACK (51754-6015), PACK (51754-6000), PACK (51754-6001), PACK (51754-6013)

Revised: 08/2018 Exela Pharma Sciences, LLC

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