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Eligen B12™ is indicated for the dietary management of patients who have a diagnosed vitamin B12 deficiency that cannot be managed by a modification of the normal diet alone. This deficiency can be caused by a range of conditions in which there is an impaired capacity to absorb vitamin B12.
Eligen B12™ is contraindicated in patients with hypersensitivity to cobalt, vitamin B12 or any component of Eligen B12™.
Eligen B12™ is contraindicated in patients with hereditary optic nerve atrophy. Do not use in patients with early hereditary optic nerve atrophy (Leber’s disease). Treatment with vitamin B12 has resulted in severe and swift optic atrophy.
Anaphylactic shock and death have been reported after parenteral vitamin B12 administration. No such reactions have been reported during limited clinical trials with Eligen B12™.
Hypokalemia and sudden death may occur in severe megaloblastic anemia treated intensely with vitamin B12. Folic acid is not a substitute for vitamin B12, although it may improve vitamin B12-deficient megaloblastic anemia. Exclusive use of folic acid in treating vitamin B12-deficient megaloblastic anemia could result in progressive and irreversible neurologic damage.
Blunted or impeded therapeutic response to vitamin B12 may be due to such conditions as infection, uremia, use of drugs having bone marrow-suppressant properties (such as chloramphenicol), and concurrent iron or folic acid deficiency.
Vitamin B12 deficiency that is allowed to progress for longer than 3 months may produce permanent degenerative lesions of the spinal cord. Doses of folic acid greater than 0.1 mg per day may result in hematologic remission in patients with vitamin B12 deficiency. Neurologic manifestations will not be prevented with folic acid; if not treated with vitamin B12, irreversible damage will result.
Doses of vitamin B12 exceeding 10 mcg a day may produce hematologic response in patients with folate deficiency. Vitamin B12 is not a substitute for folic acid, and indiscriminate use of vitamin B12 could mask the true diagnosis.
Vitamin B12 deficiency may suppress the sign of polycythemia vera. Treatment with vitamin B12 may unmask this condition.
No specific adverse reactions were identified during the limited studies with
It is not known whether vitamin B12 supplementation causes fetal harm or affects reproduction capacity when administered to a pregnant woman.
The safety and efficacy of Eligen B12™ have not been established in patients below the age of 18 years.