Rapid Opioid Countermeasure System “ROCS”
Designed for Military Personnel, First Responders, & Chemical Incident Responders
Product Highlights
Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues.
- Only naloxone product with two indications – post-exposure and temporary prophylactic use ahead of the mission
- Approved by the U.S. Food and Drug Administration (FDA) in February 2022
- Highest FDA-approved dosage as a countermeasure against high-potency opioids
- Issued NATO Stock Number #6505-01-699-8878
- Naloxone Auto-Injector (NAI) 10 mg passes U.S. Department of Defense military standard durability tests3
- First to meet FDA draft guidance standard for 99.999% device reliability
- For those outside the U.S.; the product is available to allied foreign military services through the U.S. Department of Defense (FMS) or through direct sales via expanded access approval exclusively for government or military use.
Instructions for Use
Step One
Firmly pull the auto-injector from the outer case.
Step Two
Pull off the red safety guard.
Step Three
Place the black end of the auto-injector against the outer thigh, through clothing or personal protective equipment. Press firmly until you hear a click and hiss and hold in place for 5 seconds.
If symptoms return, administer an additional dose of Naloxone Auto-Injector 10mg.
Device Configuration
DESIGNED IN PARTNERSHIP WITH THE U.S. DEPARTMENT OF DEFENSE
“Access to a point-of-injury countermeasure such as the 10mg naloxone autoinjector is a major step forward to protect and maintain the readiness of the Joint Force”
-Col Ryan R. Eckmeier, U.S. Army
Specifications
| Strength | 10 mg |
| Size | Approx. 2” wide x 3.4” height x 0.54” depth, Approx. 5.08cm wide x 8.636cm height x 1.3716cm depth |
| Weight | Approx. 58 grams |
| Mechanism of Action | Opioid receptor antagonist |
| Route of Administration | Intramuscularly or subcutaneously into the anterolateral aspect of the thigh (can be administered through clothing) |
| NATO Stock Number (NSN) | 6505-01-699-8878 |
| NDC Code | 60842-002-02 |
| Sterile | Yes |
| Grade | USP |
| Storage Requirements | Do not freeze. Protect from heat. Store at controlled room temperature 59F-77F (15C-25C); excursions permitted between 39F and 104F (4C and 40C). |
| Container Type | Carton containing ten (10) Naloxone Hydrochloride Injection, USP Auto-Injector 10mg |
| Brand | Naloxone Auto-Injector 10mg |
| Active Ingredient | Naloxone HCI |
| Dosage Form | Injection |
INDICATION
Naloxone hydrochloride injection (USP, 10 mg Auto-Injector) is an opioid antagonist indicated for use by military personnel and chemical incident responders for:
- Emergency treatment of patients 12 years of age and older where the use of high-potency opioids, such as fentanyl analogues as a chemical weapon, is suspected.
- Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids, such as fentanyl analogues.
Training Device
Practice With A Trainer
For additional information on the injection technique for Naloxone Auto-Injector 10 mg, please select the Instructions For Use.
Kaléo is a market leader in emergency-use auto-injectors committed to protecting military, police, and emergency responders. Our gas-powered auto-injector is durable, reliable, and compact, designed to preserve and make a difference in people’s lives.
A countermeasure to the threat of Synthetic Opioids
“ROCS” is a device designed to be useful in protecting military personnel and first responders who may come in contact with ultra-potent opioids in the fulfillment of their duties or during a mass casualty event. Naloxone Auto-Injector 10mg can be administered through clothing, including personal protective equipment such as MOPP4. Removal of personal protective equipment is not required.
Weaponized opioids deployed in a threat-based dynamic environment
Illicit drug production facilities with aerosolized opioids
Domestic terrorist attack using weaponized opioids
Land-based or maritime drug interdiction for mass quantity opioid exposure
Usability and Simulated Real-World Use Scenarios
Study One:
Sixty Law Enforcement & Emergency Medical Services Personnel
Untrained participants – half of whom were experienced with a trainer for a similar autoinjector – were instructed to administer NAI 10 mg to an opioid overdose victim (manikin) in a simulated sports bar/recreational area.
The testing environment included variables aimed at inducing stress (e.g., low lighting, flashing disco lights, loud music, beeping that increased in frequency and loudness, and live patron bystanders).
100% Completed a Simulation
Study Two:
Fifteen Military Personnel
A week after instructor-led training on NAI 10 mg use, participants were asked to don MOPP4 and administer NAI 10 mg to an unconscious soldier (manakin also wearing PPE) and themselves (due to a breach in PPE) in a simulated scenario where a high-potency opioid had been released in a populated area.
In addition to the challenges inherent with MOPP Level 4 (e.g., impaired dexterity, tactility, visibility), environmental challenges included emergency sirens/alarms, fog, darkness, flashing emergency lights, crowded space, multiple casualties, and beeping that increased in frequency/loudness.
100% Completed a Simulation
Limitations: These studies were sponsored by Kaléo. As this was a simulated use scenario, participants may not have experienced the same level of stress that they might experience during an actual event.