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:
Exela Pharma Sciences, LLC
Lenoir, NC 28645
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- 3 mL Syringe Label
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
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
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
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
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
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
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
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
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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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