premiere [300:200 ng/L) and slightly higher than those seen 2 to 4 weeks after administration of IM vitamin B 12 (see Figure 1 - average mean increase from Visit 1 to Visits 3-6 = 45 ng/L). Twenty-three of these 24 patients received 50 mcg of Calo Mist daily for the duration of the trial; the remaining patient required doubling of the Calo Mist dose from 50 mcg to 100 mcg daily during the last week of the study because of declining vitamin B 12 concentrations. One of the 25 patients dosed with Calo Mist was excluded from the efficacy analyses because a diagnosis of vitamin B 12 deficiency could not be confirmed. Figure 1. Mean Vitamin B 12 Serum Levels Over 8 Weeks of Intranasal (IN) Vitamin B 12 Dosing in 24 Subjects Stabilized on Intramuscular (IM) Vitamin B 12 Notes: Weeks -2 to -4 correspond to 2 to 4 weeks post last IM injection Calo Mist was initiated at Week 0 Figure shows mean vitamin B 12 serum levels with 95% confidence intervals. Pharmacokinetics Distribution In the blood, vitamin B 12 is bound to transcobalamin II (a specific B-globulin carrier protein) and is distributed to tissues and stored primarily in the liver and bone marrow. Elimination About 3-8 mcg of vitamin B 12 is secreted into the gastrointestinal tract daily via the bile. In subjects with sufficient intrinsic factor, all but about 1 mcg is reabsorbed. When vitamin B 12 is administered in doses that saturate the binding capacity of plasma proteins and the liver, the unbound vitamin B 12 is rapidly eliminated in the urine. Retention of vitamin B 12 in the body is dose-dependent. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility There are no long-term studies in animals that have evaluated the carcinogenic potential of any of the vitamin B 12 products, including Calo Mist . There is no evidence from long-term use in patients with pernicious anemia that vitamin B 12 is carcinogenic. Pernicious anemia is associated with an increased incidence of carcinoma of the stomach, but this malignancy has been attributed to the underlying pathology of pernicious anemia and not to treatment with vitamin B 12 . How Supplied/Storage and Handling Calo Mist is available as a metered dose spray in 30 mL plastic bottles containing 10.7 mL of solution. Calo Mist is available in a dosage strength of 25 mcg cyanocobalamin, USP, per actuation (0.1 mL/actuation). Calo Mist is provided in a carton containing one bottle of nasal spray solution affixed with a nasal spray pump, a package insert, and a patient instruction sheet. One bottle delivers thirty 50 mcg doses (60 sprays) (NDC 0256-0203-01). Storage Protect from light. Store upright at a controlled temperature of 15 to 30 C (59 to 86 F). Protect from freezing. Patient Counseling Information [ See FDA-approved Patient Labeling ( 17.2 ) ] Important Information for Patients Patients with a chronic underlying cause of vitamin B 12 deficiency will require indefinite administration of a vitamin B 12 product, such as Calo Mist . Noncompliance or inadequate treatment with vitamin B 12 therapy may result in recurrence of anemia and the development or worsening of irreversible neurological damage. The dosing of Calo Mist and other intranasal medications should be separated by several hours. Vitamin B 12 concentrations should be monitored one month after Calo Mist initiation or dose change and every 3-6 months thereafter. Careful instructions on the priming of the actuator and nasal administration of Calo Mist should be given to the patient, and the procedures for use should be demonstrated. Patient Instruction Sheet Instructions for Using Calo Mist . Read the following instructions carefully before using Calo Mist . Use Calo Mist as directed by your doctor. NOTE: Calo Mist is prefilled to give 30 doses (60 sprays of medicine). One dose is one spray in each nostril once a day. Calo Mist Pump Priming: Before you use the medicine for the first time the nasal spray pump unit must be readied (primed). 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) 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 7 th priming spray. ( See Diagram 2 ) NOTE: You must prime Calo Mist with two re-priming sprays if you do not use for five days or more. Your Calo Mist is now ready to use. 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. Place your thumb on the bottom of the bottle. ( See Diagram 4 ) 3. Gently insert the nasal spray pump into one nostril (about inch), pointing the tip towards the back of the nose. ( See Diagram 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. Firmly and quickly press down the arms of the nasal spray bottle. 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. After use, wipe the nozzle of the nasal spray pump with a clean tissue. Replace the safety clip and clear cover on the nasal spray pump. 8. Store Calo Mist upright at room temperature, 15 - 30 C (59 - 86 F). Do not freeze. Discard Calo Mist after 30 doses (60 sprays). Unscrew the cap. Rinse the bottle and pump assembly under a water faucet. Dispose of all parts in a trashcan. Keep Calo Mist and all medicines out of the reach of children. Manufactured by: Fleming Pharmaceuticals St. Louis County, MO 63026 USA Calomist@flemingpharma.com 1-800-343-0164 Principal Display Panel - carton principal display panel - carton Principal Display Panel - bottle principal display panel - bottle Calomist cyanocobalamin spray, metered Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0256-0203 Route of Administration NASAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 25 ug in 0.1 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE BENZYL ALCOHOL SODIUM HYDROXIDE BENZALKONIUM CHLORIDE WATER Packaging # Item Code Package Description 1 NDC:0256-0203-01 1 BOTTLE, PUMP (BOTTLE) in 1 CARTON 1 10.7 mL in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022102 10/01/2007 01/26/2010 Labeler - Fleming & Company, Pharmaceuticals (006491351) Establishment Name Address ID/FEI Operations Fleming & Company, Pharmaceuticals 006491351 MANUFACTURE, ANALYSIS, RELABEL, REPACK Revised: 01/2010 Fleming & Company, Pharmaceuticals Next Interactions Print this page Add to My Med List More about CaloMist (cyanocobalamin) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group 1 Review Add your own review/rating Drug class: vitamins Consumer resources Calomist CaloMist (Advanced Reading) Professional resources Cyanocobalamin (FDA) Other brands: Nascobal Related treatment guides B12 Nutritional Deficiency Pernicious Anemia Schilling Test Vitamin B12 Deficiency] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Vitamins Related Drugs vitamins cholecalciferol , cyanocobalamin , folic acid , ergocalciferol , Vitamin D3 , biotin Vitamin B12 Deficiency cyanocobalamin , Vitamin B12 , B-12 , Cyanokit , hydroxocobalamin , Nascobal , More... Pernicious Anemia cyanocobalamin , Vitamin B12 , B-12 , Nascobal , More... Schilling Test cyanocobalamin , Vitamin B12 , B-12 , Cyanokit , hydroxocobalamin , Nascobal , More... 1 more conditions... CaloMist Rating 1 User Review 10 /10 1 User Review 10 Rate it! new edition
by no means Calomist growing older
EmoticonEmoticon