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DUODOTE- atropine and pralidoxime chloride kit


  1. Patient Information
  2. Manufactured By:
  3. The Number Of Duodote Autoinjectors To Administer To An Individual Is Based On Severity Of Symptoms. Common Symptoms Of Organophosphorus Exposure Are Listed Below. Individuals May Not Have All Symptoms:
  4. Revised: 10/2018document Id:

Patient Information 

Use by Healthcare Providers
DuoDote is intended for use by Healthcare Providers. See the illustratedInstruction Sheet for Healthcare Providers.

Seek Definitive Medical Care
If feasible and appropriate, advise patients that DuoDote is an initial emergency treatment, that they need additional care at a healthcare facility.

Avoid Overheating
If feasible and appropriate, advise the patient to avoid a hot environment and excessive physical activity since DuoDote can inhibit sweating which can lead to overheating and heat injury.

Manufactured By: 


Meridian Medical Technologies, Inc.
Columbia, MD 21046
A Pfizer Company

Instruction Sheet for
Healthcare Providers

DuoDote should be administered by healthcare providers who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication.

Individuals should not rely solely upon atropine and pralidoxime to provide complete protection from chemical nerve agents and insecticide poisoning.

Primary protection against exposure to chemical nerve agents and insecticide poisoning is the wearing of protective garments including masks designed specifically for this use.

Evacuation and decontamination procedures should be undertaken as soon as possible. Medical personnel assisting evacuated victims of nerve agent poisoning should avoid contaminating themselves by exposure to the victim's clothing.

DuoDote is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds). DuoDote should only be administered to patients experiencing symptoms of organophosphorus poisoning in a situation where exposure is known or suspected. DuoDote should be administered as soon as symptoms of organophosphorus poisoning appear.

The Number Of Duodote Autoinjectors To Administer To An Individual Is Based On Severity Of Symptoms. Common Symptoms Of Organophosphorus Exposure Are Listed Below. Individuals May Not Have All Symptoms: 

Mild SymptomsSevere Symptoms
  • Blurred vision, miosis
  • Excessive, unexplained teary eyes
  • Excessive, unexplained runny nose
  • Increased salivation such as sudden drooling
  • Chest tightness or difficulty breathing
  • Tremors throughout the body or muscular twitching
  • Nausea and/or vomiting
  • Unexplained wheezing, coughing or increased airway secretions
  • Acute onset of stomach cramps
  • Tachycardia or bradycardia
  • Strange or confused behavior
  • Severe difficulty breathing or copious secretions from lungs/airway
  • Severe muscular twitching and general weakness
  • Involuntary urination and defecation
  • Convulsions
  • Unconsciousness

Dosage for Mild Symptoms in Adults and Pediatric Patients Weighing More Than 41 kg (90 Pounds)
First Dose: Administer one (1) DuoDote injection into the mid-lateral thigh if the patient experiences two or moremildsymptoms of nerve agent or insecticide exposure.

Trained healthcare providers with mild symptoms may self-administer a single dose of DuoDote.

Wait 10 to 15 minutes for DuoDote to take effect. If, after 10 to 15 minutes, the patient does not develop any of theseveresymptoms listed above, no additional DuoDote injections are recommended, but definitive medical care should ordinarily be sought immediately. For healthcare providers who have self-administered DuoDote, an individual decision will need to be made to determine their capacity to continue to provide emergency care.

Additional Doses: If,at any time after the first dose, the patient develops any of theseveresymptoms listed above, administer two (2) additional DuoDote injections in rapid succession, and immediately seek definitive medical care.

Dosage for Severe Symptoms in Adults and Pediatric Patients Weighing More Than 41 kg (90 Pounds)
If a patient has any of theseveresymptoms listed above, immediately administer three (3) DuoDote injections into the patient's mid-lateral thigh in rapid succession, and immediately seek definitive medical care.

Emergency care of the severely poisoned individual should include removal of oral and bronchial secretions, maintenance of a patent airway, supplemental oxygen, and, if necessary, artificial ventilation.

An anticonvulsant such as a benzodiazepine may be administered to treat convulsions if suspected in the unconscious individual. The effects of nerve agents and some insecticides can mask the motor signs of a seizure.

Close supervision of all severely poisoned patients is indicated for at least 48 to 72 hours.

Instructions for Use of the DuoDote Autoinjector

Do Not Remove Gray Safety Release until ready to use

Never touch the Green Tip (Needle End)!

Weight Guidelines

Figure
For use with adults and pediatric patients weighing more than 41 kg (90 lb).For patients weighing less than or equal to 41 kg (90 lb) use the appropriate dose of:
  • AtroPenor atropine from a vial
  • Pralidoxime chloride from a vial
1)
Tear open the plastic pouch at any of the notches. Remove the DuoDote autoinjector from the pouch.Figure
2)
Place the DuoDote autoinjector in your dominant hand. (If you are right-handed, your right hand is dominant.) Firmly grasp the center of the DuoDote autoinjector with the Green Tip (needle end) pointing down.Figure
3)
With your other hand, pull off the Gray Safety Release. DuoDote is now ready to be administered.Figure
4)
The injection site is the mid-lateral thigh area. The DuoDote autoinjector can inject through clothing. However, make sure pockets at the injection site are empty.
People who may not have a lot of fat at the injection site should also be injected in the mid-lateral thigh, but before giving the injection, bunch up the thigh to provide a thicker area of injection.Figure
5)
Firmly push the Green Tip straight down (at a 90 angle) against the mid-lateral thigh. Continue to firmly push until you feel the DuoDote autoinjector trigger.Figure

IMPORTANT: After the autoinjector triggers, hold the DuoDote autoinjector firmly in place against the injection site for approximately 10 seconds.

6)
Remove the DuoDote autoinjector from the thigh and look at the Green Tip. If the needle is visible, the drug has been administered. If the needle is not visible, check to be sure the Gray Safety Release has been removed, and then repeat above steps beginning with Step 4, but push harder in Step 5.Figure
7)
After the drug has been administered, push the needle against a hard surface to bend the needle back against the DuoDote autoinjector.Figure
8)
Put the used DuoDote autoinjector back into the plastic pouch, if available. Leave used DuoDote autoinjector(s) with the patient to allow other medical personnel to see the number of DuoDote autoinjector(s) administered.
9)
Immediately move yourself and the patient away from the contaminated area and seek definitive medical care for the patient.

DuoDoteis a registered trademark of:
Meridian Medical Technologies, Inc.
Columbia, MD 21046
A Pfizer Company
1-800-438-1985
2016 by Meridian Medical Technologies, Inc., a Pfizer company
Revised: 10/2017
0002022

Principal Display Panel - DuoDote Carton Label

For use in
NERVE AGENT
orINSECTICIDE
POISONING

For adults and pediatric
patients weighing

41 kg +

or 90 lb +

NDC 11704-620-01

DuoDoteAUTO-INJECTOR

(atropine and pralidoxime chloride injection)

Each auto-injector delivers an intramuscular injection of
2.1 mg of atropine and 600 mg of pralidoxime chloride
equivalent to 476.6 mg of pralidoxime

Store at 25 C (77 F). Excursions permitted to 15-30 C (59-86 F).

Keep from freezing. Protect from light.

Rx Only

11704-62001

Principal Display Panel - DuoDote Carton Label
DUODOTE
atropine and pralidoxime chloride kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11704-620
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11704-620-011 in 1 CARTON; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)09/28/2006
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 SYRINGE, PLASTIC0.7 mL
Part 21 SYRINGE, PLASTIC2 mL
Part 1 of 2
DUODOTE AUTO-INJECTOR
atropine injection
Product Information
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
atropine(UNII: 7C0697DR9I) (atropine - UNII:7C0697DR9I)atropine2.1 mg in 0.7 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin(UNII: PDC6A3C0OX)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Phenol(UNII: 339NCG44TV)
Water(UNII: 059QF0KO0R)
Sodium Citrate(UNII: 1Q73Q2JULR)
Nitrogen(UNII: N762921K75)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
11 in 1 POUCH
10.7 mL in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02198309/28/2006
Part 2 of 2
DUODOTE AUTO-INJECTOR
pralidoxime chloride injection
Product Information
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
pralidoxime chloride(UNII: 38X7XS076H) (pralidoxime - UNII:P7MU9UTP52)pralidoxime chloride600 mg in 2 mL
Inactive Ingredients
Ingredient NameStrength
Benzyl Alcohol(UNII: LKG8494WBH)
Glycine(UNII: TE7660XO1C)
Water(UNII: 059QF0KO0R)
Hydrochloric Acid(UNII: QTT17582CB)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
11 in 1 POUCH
12 mL in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02198309/28/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02198309/28/2006
Labeler -Meridian Medical Technologies, Inc. (167671341)
Establishment
NameAddressID/FEIBusiness Operations
Meridian Medical Technologies , Inc.167671341MANUFACTURE(11704-620) , LABEL(11704-620) , PACK(11704-620) , ANALYSIS(11704-620)
Establishment
NameAddressID/FEIBusiness Operations
Meridian Medical Technologies, Inc.078808315MANUFACTURE(11704-620) , LABEL(11704-620) , PACK(11704-620)
Establishment
NameAddressID/FEIBusiness Operations
Meridian Medical Technologies, Inc.038889234MANUFACTURE(11704-620) , ANALYSIS(11704-620)

Revised: 10/2018document Id: 

115a375f-3295-4fb0-b3a2-7d9018abe53aSet id: 241f42a0-1a33-40e8-8221-201767d999e5Version: 12Effective Time: 20181022Meridian Medical Technologies, Inc.



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