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CaloMist Nasal Spray

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CaloMist Nasal Spray

PATIENT INFORMATION

PATIENT COUNSELING INFORMATION

[See FDA-approved Patient Labeling]

Important Information for Patients

Patients with a chronic underlying cause of vitamin B12 deficiency will require indefinite administration of a vitamin B12 product, such as CaloMist Nasal Spray. Noncompliance or inadequate treatment with vitamin B12 therapy may result in recurrence of anemia and the development or worsening of irreversible neurological damage.

The dosing of CaloMist Nasal Spray and other intranasal medications should be separated by several hours.

Vitamin B12 concentrations should be monitored one month after CaloMist Nasal Spray initiation or dose change and every 3-6 months thereafter.

Careful instructions on the priming of the actuator and nasal administration of CaloMist Nasal Spray should be given to the patient, and the procedures for use should be demonstrated.

Patient Instruction Sheet

Instructions for Using CaloMist Nasal Spray. Read the following instructions carefully before using CaloMist Nasal Spray.

  • Use CaloMist Nasal Spray as directed by your doctor.

NOTE: CaloMist Nasal Spray is prefilled to give 30 doses (60 sprays of medicine). One dose is one spray in each nostril once a day.

CaloMist Nasal Spray Pump Priming: Before you use the medicine for the first time the nasal spray pump unit must be readied (primed).

CaloMist Nasal Spray Pump Priming - Illustration 1

1. Hold the nasal spray bottle upright with your index finger on top of one of the two arms of the pump. Remove the clear protective cap from the top of the nozzle. (See Diagram 1)

2. Remove the safety clip from the nasal spray pump. (See Diagram 1)

CaloMist Nasal Spray Pump Priming - Illustration 2

3. While holding the nasal spray bottle upright with your index and middle fingers on the two side arms of the pump, and your thumb on the bottom of the bottle, press the arms down firmly and quickly. (See Diagram 2)

4. Repeat Step 3, 6 more times for a total of 7 priming sprays. You should see a full spray of medicine with the 7th priming spray. (See Diagram 2)

NOTE: You must prime CaloMist Nasal Spray with two re-priming sprays if you do not use for five days or more.

Your CaloMist Nasal Spray is now ready to use.

Blow your nose gently to clear both nostrils - Illustration 3

1. Blow your nose gently to clear both nostrils. (See Diagram 3)

2. Hold the nasal spray bottle upright with your first and second fingers on the two side arms of the pump, and your thumb on the bottom of the bottle. (See Diagram 4)

3. Gently insert the nasal spray pump to one nostril (about ½ inch), pointing the tip towards the back of the nose. (See Diagram 4)

Gently insert the nasal spray pump to one nostril - illustration 4

4. With your other hand (the one not holding the bottle) use a finger to gently push close your other nostril (the one without a spray pump inserted). (See Diagram 4)

5. Tilt your head forward and press the arms of the nasal spray bottle down firmly and quickly.

6. Sniff in gently during and right after a spray and return your head to an upright position. Repeat these steps for the other nostril.

7. Wipe the nozzle of the nasal spray pump with a clean tissue after use. Replace the safety clip and clear cover on the nasal spray pump.

8. Store CaloMist Nasal Spray upright at room temperature, 59 to 86° F (15 to 30° C). Do not freeze.

Discard CaloMist Nasal Spray after 30 doses (60 sprays).

  1. Unscrew the cap, rinse the bottle and pump assembly under a water faucet.
  2. Dispose of all parts in a trashcan.

Keep CaloMist Nasal Spray and all medicines out of the reach of children.

Last reviewed on RxList: 8/16/2007
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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