Supply & Manufacturing

Celebrating 30 Years of Diprivan^®: How Propofol Transformed the Practice of Anesthesia.

How Fresenius Kabi makes sure Diprivan is there for you.

Fresenius Kabi leadership: our ongoing investments have enabled us to meet U.S. propofol demand.

From obtaining the raw materials to delivering Diprivan, it can take as much as 6 months to produce a vial.

We begin by sourcing components of the drug and the packaging materials, which include many things like: API (Active Pharmaceutical Ingredient), glass vials, stoppers, labels, shipping materials, and much more.

Next comes production planning: making sure we have everything we need to meet demand for Diprivan. We prepare for bulk production by assessing the ingredients using specific software.

The emulsion is prepared by mixing, filtering, and homogenizing in a series of precise steps.

Quality control monitors and inspects the vials at every step, where product- and process-specific parameters are analyzed.

Vials are carefully filled, sealed, and crimped in a sterile, clean room.

Product quality is analyzed by batch in a series of tests. If the batch is good, the process keeps moving.

After inspection, the vials are labeled and packaged.

In the final weeks, the vials are shipped and stored under temperature-controlled conditions.

Many things can affect this process. For example, a shortage of materials or surge in demand. So we keep a 6-month inventory of raw materials on hand in our manufacturing facilities.

We don’t make Diprivan in just one manufacturing facility. We have global production sites approved to produce Diprivan. If there’s a problem in one facility, another can pick up the shortfall.

We also strive to keep 4 months’ inventory of finished Diprivan in our domestic warehouses so we’re well ahead of demand.

And our ongoing investments will continue to support your needs today and tomorrow. That’s why Fresenius Kabi can confidently supply you with Diprivan when you need it.

Fresenius Kabi’s response to the propofol drug shortages.

Fresenius Kabi increased Diprivan supply manufacturing product in multiple facilities to guard against any supply interruptions.

*Based on the average annual units supplied during the time frame shown.
**Based on the percentage increase over the 2008 — 2009 average.

REFERENCE
1. Data on file.

For U.S. Healthcare Professionals

See Full Prescribing Information

Important Safety Information

CONTRAINDICATIONS
DIPRIVAN is contraindicated in patients with Known hypersensitivity to propofol, egg or soybean.

WARNING AND PRECAUTIONS
Hypersensitivity Reactions: Serious and sometimes fatal reactions.

Microbial Contamination: Strict aseptic technique must be maintained during handling. DIPRIVAN vials are never to be accessed more than once or used on more than one person. Administration should commence promptly and be completed within 12 hours after the vial has been opened. Discard unused drug product. Do not use if contamination is suspected.

Cardiovascular depression: Cases of bradycardia, asystole, and cardiac arrest have been reported. Pediatric patients are susceptible to this effect, particularly when fentanyl is given concomitantly.

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ADVERSE REACTIONS

The most common adverse reactions >1% were bradycardia, arrhythmia, tachycardia, hypotension, hypertension, decreased cardiac output, movement, apnea, respiratory acidosis during weaning, rash, pruritus, burning/stinging or pain at injection site, and hyperlipemia.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Opioids, Sedatives or Other Analgesic Agents: May increase the anesthetic/ sedative and cardiorespiratory effects.

Valproate: May lead to increased blood levels of propofol.

INDICATIONS AND USAGE

DIPRIVAN is an intravenous general anesthetic and sedation drug indicated for:

Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age.
Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age.
Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients.
Sedation for Adult Patients in Combination with Regional Anesthesia.
Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients.

Limitations of Use:

DIPRIVAN is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months.
MAC sedation in the pediatric population is not recommended. DIPRIVAN is not indicated for use in Pediatric ICU sedation.

This Important Safety Information does not include all the information needed to use DIPRIVAN^® (Propofol), Injectable Emulsion, USP safely and effectively. Please see full prescribing information for DIPRIVAN^® (Propofol), Injectable Emulsion, USP. Full prescribing information is also available at www.fresenius-kabi.com/us.