hydromorphone hydrochloride injection, USP How Supplied/Storage and Handling

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How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

Safety and Handling Instructions

Access to drugs with a potential for abuse such as Hydromorphone Hydrochloride Injection presents an occupational hazard for addiction in the health care industry. Routine procedures for handling controlled substances developed to protect the public may not be adequate to protect health care workers. Implementation of more effective accounting procedures and measures to restrict access to drugs of this class (appropriate to the practice setting) may minimize the risk of self-administration by health care providers.

How Supplied

Hydromorphone Hydrochloride is as a sterile solution in single-dose amplules, single-dose CarpujectTM cartridges with Luer Lock for use with CarpujectTM Syringe System and Carpuject Holder ONLY, single‑dose iSecureTM prefilled syringes with Luer Lock, and single-dose vials for intravenous, intramuscular, and subcutaneous administration, and available as follows:

Unit of Sale	Concentration (per total volume)
NDC 0409-2552-01 Carton of 10 1 mL fill in 1 mL Single-dose Ampul	1 mg/mL
NDC 0409-3356-01 Carton of 10 1 mL fill in 1 mL Single-dose Ampul	2 mg/mL
NDC 0409-2540-01 Carton of 10 1 mL fill in 1 mL Single-dose Ampul	4 mg/mL
NDC 0409-3365-01 Tray of 25 1 mL fill in 2 mL Single-dose Vial	2 mg/mL
NDC 0409-3365-10 Carton of 10 1 mL fill in 2 mL Single-dose Vial	2 mg/mL
NDC 0409-1283-31 Carton of 10 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the use with Carpuject™ Syringe System	1 mg/mL
NDC 0409-1312-30 Carton of 10 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the use with Carpuject™ Syringe System	2 mg/mL
NDC 0409-1304-31 Carton of 10 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the use with Carpuject™ Syringe System	4 mg/mL
NDC 0409-1283-05 Carton of 10 0.5 mL fill in 1.5 mL iSecure™ Single-dose Prefilled Syringe with Luer Lock	0.5 mg/0.5 mL
NDC 0409-1283-10 Carton of 10 1 mL fill in 1.5 mL iSecure™ Single-dose Prefilled Syringe with Luer Lock	1 mg/mL
NDC 0409-1312-10 Carton of 10 1 mL fill in 1.5 mL iSecure™ Single-dose Prefilled Syringe with Luer Lock	2 mg/mL

Carpuject™ Single-dose cartridges with Luer Lock are packaged in a Slim-Pak™ tamper detection package. Note that a needle is not included.

PROTECT FROM LIGHT

Keep covered in carton until time of use. 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].

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