Physicians Ez Use B-12 Compliance

Antiseptic

For first aid to decrease germs in minor cuts scrapes burns For preparation of the skin prior to injection

INDICATIONS AND USAGE Cyanocobalamin is indicated for Vitamin B 12 deficiencies due to malabsorption which may be associated with the following conditions: Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of pancreas or bowel Folic acid deficiency It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug/Laboratory Test Interactions ), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of Vitamin B 12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin injection is also suitable for the Vitamin B 12 absorption test (Schilling test).

Isopropyl Alcohol 70% v/v

Sensitivity to cobalt and/or Vitamin B 12 is a contraindication.

with electrocautery procedures

do not get into eyes apply over large areas of the body in case of deep or puncture wounds, animal bites or serious burns consult a doctor

condition persists or gets worse or lasts for more than 72 hours do not use longer than 1 week unless directed by a doctor

For external use only Flammable – keep away from fire or flame Do not use with electrocautery procedures When using this product do not get into eyes apply over large areas of the body in case of deep or puncture wounds, animal bites or serious burns consult a doctor Stop use and ask a doctor if condition persists or gets worse or lasts for more than 72 hours do not use longer than 1 week unless directed by a doctor Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

WARNINGS WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Patients with early Leber’s disease (hereditary optic nerve atrophy) who were treated with cyanocobalamin suffered severe and swift optic atrophy. Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely. Anaphylactic shock and death have been reported after parenteral Vitamin B 12 administration. An intradermal test dose is recommended before cyanocobalamin injection is administered to patients suspected of being sensitive to this drug. This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal ‘‘Gasping Syndrome’’ in premature infants.

General Vitamin B 12 deficiency that is allowed to progress for longer than three months may produce permanent degenerative lesions of the spinal cord. Doses of folic acid greater than 0.1 mg/day may result in hematologic remission in patients with Vitamin B 12 deficiency. Neurologic manifestations will not be prevented with folic acid, and if not treated with Vitamin B 12 , irreversible damage will result. Doses of cyanocobalamin exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis. Information for Patients Patients with pernicious anemia should be instructed that they will require monthly injections of Vitamin B 12 for the remainder of their lives. Failure to do so will result in return of the anemia and in development of incapacitating and irreversible damage to the nerves of the spinal cord. Also, patients should be warned about the danger of taking folic acid in place of Vitamin B 12 , because the former may prevent anemia but allow progression of subacute combined degeneration. A vegetarian diet which contains no animal products (including milk products or eggs) does not supply any Vitamin B 12 . Patients following such a diet should be advised to take oral Vitamin B 12 regularly. The need for Vitamin B 12 is increased by pregnancy and lactation. Deficiency has been recognized in infants of vegetarian mothers who were breast fed, even though the mothers had no symptoms of deficiency at the time. Laboratory Tests During the initial treatment of patients with pernicious anemia, serum potassium must be observed closely the first 48 hours and potassium replaced if necessary. Hematocrit, reticulocyte count, Vitamin B 12 , folate and iron levels should be obtained prior to treatment. Hematocrit and reticulocyte counts should be repeated daily from the 5th to 7th days of therapy and then frequently until the hematocrit is normal. If folate levels are low, folic acid should also be administered. If reticulocytes have not increased after treatment or if reticulocyte counts do not continue at least twice normal as long as the hematocrit is less than 35%, diagnosis or treatment should be reevaluated. Repeat determinations of iron and folic acid may reveal a complicating illness that might inhibit the response of the marrow. Patients with pernicious anemia have about three times the incidence of carcinoma of the stomach as the general population, so appropriate tests for this condition should be carried out when indicated. Drug/Laboratory Test Interactions Persons taking most antibiotics, methotrexate and pyrimethamine invalidate folic acid and Vitamin B 12 diagnostic blood assays. Colchicine, para-aminosalicylic acid and heavy alcohol intake for longer than two weeks may produce malabsorption of Vitamin B 12 . Carcinogenesis, Mutagenesis Long-term studies in animals to evaluate carcinogenic potential have not been done. There is no evidence from long-term use in patients with pernicious anemia that cyanocobalamin is carcinogenic. Pernicious anemia is associated with an increased incidence of carcinoma of the stomach, but this is believed to be related to the underlying pathology and not to treatment with cyanocobalamin. Pregnancy Pregnancy Category C —Adequate and well-controlled studies have not been done in pregnant women. However, Vitamin B 12 is an essential vitamin and requirements are increased during pregnancy. Amounts of Vitamin B 12 that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for pregnant women (4 mcg daily) should be consumed during pregnancy. Nursing Mothers Vitamin B 12 is known to be excreted in human milk. Amounts of Vitamin B 12 that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for lactating women (4 mcg daily) should be consumed during lactation . Pediatric Use Intake in children should be in the amount (0.5 to 3 mcg daily) recommended by the Food and Nutrition Board, National Academy of Science-National Research Council.

General Vitamin B 12 deficiency that is allowed to progress for longer than three months may produce permanent degenerative lesions of the spinal cord. Doses of folic acid greater than 0.1 mg/day may result in hematologic remission in patients with Vitamin B 12 deficiency. Neurologic manifestations will not be prevented with folic acid, and if not treated with Vitamin B 12 , irreversible damage will result. Doses of cyanocobalamin exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis.

Information for Patients Patients with pernicious anemia should be instructed that they will require monthly injections of Vitamin B 12 for the remainder of their lives. Failure to do so will result in return of the anemia and in development of incapacitating and irreversible damage to the nerves of the spinal cord. Also, patients should be warned about the danger of taking folic acid in place of Vitamin B 12 , because the former may prevent anemia but allow progression of subacute combined degeneration. A vegetarian diet which contains no animal products (including milk products or eggs) does not supply any Vitamin B 12 . Patients following such a diet should be advised to take oral Vitamin B 12 regularly. The need for Vitamin B 12 is increased by pregnancy and lactation. Deficiency has been recognized in infants of vegetarian mothers who were breast fed, even though the mothers had no symptoms of deficiency at the time.

Laboratory Tests During the initial treatment of patients with pernicious anemia, serum potassium must be observed closely the first 48 hours and potassium replaced if necessary. Hematocrit, reticulocyte count, Vitamin B 12 , folate and iron levels should be obtained prior to treatment. Hematocrit and reticulocyte counts should be repeated daily from the 5th to 7th days of therapy and then frequently until the hematocrit is normal. If folate levels are low, folic acid should also be administered. If reticulocytes have not increased after treatment or if reticulocyte counts do not continue at least twice normal as long as the hematocrit is less than 35%, diagnosis or treatment should be reevaluated. Repeat determinations of iron and folic acid may reveal a complicating illness that might inhibit the response of the marrow. Patients with pernicious anemia have about three times the incidence of carcinoma of the stomach as the general population, so appropriate tests for this condition should be carried out when indicated.

Drug/Laboratory Test Interactions Persons taking most antibiotics, methotrexate and pyrimethamine invalidate folic acid and Vitamin B 12 diagnostic blood assays. Colchicine, para-aminosalicylic acid and heavy alcohol intake for longer than two weeks may produce malabsorption of Vitamin B 12 .

Carcinogenesis, Mutagenesis Long-term studies in animals to evaluate carcinogenic potential have not been done. There is no evidence from long-term use in patients with pernicious anemia that cyanocobalamin is carcinogenic. Pernicious anemia is associated with an increased incidence of carcinoma of the stomach, but this is believed to be related to the underlying pathology and not to treatment with cyanocobalamin.

Pregnancy Pregnancy Category C —Adequate and well-controlled studies have not been done in pregnant women. However, Vitamin B 12 is an essential vitamin and requirements are increased during pregnancy. Amounts of Vitamin B 12 that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for pregnant women (4 mcg daily) should be consumed during pregnancy.

Nursing Mothers Vitamin B 12 is known to be excreted in human milk. […]

Generalized Anaphylactic shock and death have been reported with administration of parenteral Vitamin B 12 (see WARNINGS ). Cardiovascular Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis. Hematological Polycythemia vera. Gastrointestinal Mild transient diarrhea. Dermatological Itching; transitory exanthema. Miscellaneous Feeling of swelling of entire body.

Generalized Anaphylactic shock and death have been reported with administration of parenteral Vitamin B 12 (see WARNINGS ).

Cardiovascular Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis.

Hematological Polycythemia vera.

Gastrointestinal Mild transient diarrhea.

Dermatological Itching; transitory exanthema.

Miscellaneous Feeling of swelling of entire body.

. If swallowed, get medical help or contact a Poison Control Center right away.