Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Labels, All Index Repeat determinations of iron and folic acid may reveal a complicating illness that might inhibit the response of the marrow. Doses of folic acid greater than 0.1 mg per day may result in hematologic remission in patients with vitamin B12 deficiency. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Patients following such a diet, should be advised to take oral vitamin B12 regularly. An intradermal test dose is recommended before Cyanocobalamin Injection, USP is administered to patients suspected of being sensitive to this drug. Talk to your doctor about the amount of vitamin B, feeling as if your entire body as swollen, shortness of breath, especially when you exercise or lie down, swelling of the arms, hands, feet, ankles or lower legs, pain, warmth, redness, swelling or tenderness in one leg. ), More about getting RSS News & Updates from DailyMed, 1 mL in 1 VIAL; Type 0: Not a Combination Product, 10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product, 30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product, ANALYSIS(0143-9621, 0143-9620, 0143-9619) , LABEL(0143-9621, 0143-9620, 0143-9619) , MANUFACTURE(0143-9621, 0143-9620, 0143-9619) , PACK(0143-9621, 0143-9620, 0143-9619), 4 The major portion is excreted within the first eight hours. A vegetarian diet which contains no animal products (including milk products or eggs) does not supply any vitamin B12. There is no evidence from long-term use in patients with pernicious anemia that cyanocobalamin is carcinogenic. The liver is the main organ for vitamin B12 storage. Sensitivity to cobalt and/or vitamin B12 is a contraindication. Each vial also contains Sodium Chloride, 0.9%. Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH (range 4.5-7.0). Manufactured by: Anaphylactic shock and death have been reported after parenteral vitamin B12 administration. Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: 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 Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Repeat determinations of iron and folic acid may reveal a complicating illness that might inhibit the response of the marrow. No overdosage has been reported with this drug. PubMed, Cyanocobalamin injection also may be given as a test to see how well the body can absorb vitamin B12. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. Because it is injected straight into the bloodstream, it can be used to supply vitamin B12 to people who cannot absorb this vitamin through the intestine. The oral form is not dependable. Hematocrit, reticulocyte count, vitamin B12, folate and iron levels should be obtained prior to treatment. Cyanocobalamin injection is also sometimes used to treat inherited conditions that decrease the absorption of vitamin B12 from the intestine. You may receive cyanocobalamin injections every month for the rest of your life. Cyanocobalamin comes as a solution (liquid) to be injected into a muscle or just under the skin. Files, Presentations CyanocobalaminInjection, USPRx only10,000 mcg/10 mL(1,000 mcg/mL)For INTRAMUSCULAR orSUBCUTANEOULS USE ONLYContains Benzyl Alcoholas a Preservative Biochemical Data Summary. Keep all appointments with your doctor and the laboratory. The liver is the main organ for vitamin B12 storage. Keep all appointments to receive cyanocobalamin injections even if you feel well. FDA Safety Recalls, There is no evidence from long-term use in patients with pernicious anemia that Cyanocobalamin is carcinogenic. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. 0143-9620-01, Patients with early Leber's disease (hereditary optic nerve atrophy) who were treated with cyanocobalamin suffered severe and swift optic atrophy. By this time hematologic values should have become normal. Cyanocobalamin injection may cause other side effects. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). Patients with pernicious anemia should be informed that they will require monthly injections of vitamin B12 for the remainder of their lives. Benzyl Alcohol, 1.5%, is present as a preservative. Data sources include IBM Watson Micromedex (updated 2 Nov 2020), Cerner Multum™ (updated 2 Nov 2020), ASHP (updated 30 Sep 2020) and others. pH 4.5-7.0 adjusted withHydrochloric Acid and/or SodiumHydroxide, if needed. If you stop receiving cyanocobalamin injections, your anemia may return and your nerves may be damaged. Be sure to mention any of the following: antibiotics such as chloramphenicol; colchicine; folic acid; methotrexate (Rheumatrex, Trexall); para-aminosalicylic acid (Paser); and pyrimethamine (Daraprim). Chronic treatment should be with an oral B12 preparation. © Copyright, 2020. Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy. 10 x 30 mL Multiple Dose VialsEach mL contains: Cyanocobalamin 1,000 mcg,Sodium Chloride 9 mg, Benzyl Alcohol 0.015 mLin Water for Injection. Vitamin B12 deficiency that is allowed to progress for longer than 3 months may produce permanent degenerative lesions of the spinal cord. Contains no morethan 200 mcg/L of aluminum. Anaphylactic shock and death have been reported with administration of parenteral vitamin B12 (see WARNINGS). CyanocobalaminInjection, USPRx only30,000 mcg/30 mL(1,000 mcg/mL)For INTRAMUSCULAR orSUBCUTANEOULS USE ONLYContains Benzyl Alcoholas a Preservative View NDC Code(s)NEW! December 12, 2018. Long term studies in animals to evaluate carcinogenic potential have not been done. Generic alternatives may be available. The deficiency may occur in pernicious anemia, following surgical removal of the stomach, with fish tapeworm, or due to bowel cancer. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is then transported by the transcobalamin binding proteins. Pernicious Anemia: Parenteral vitamin B12 is the recommended treatment and will be required for the remainder of the patient's life. Use of this product intravenously will result in almost all of the vitamin being lost in the urine. Manufactured by: WARNING: PROTECT FROM LIGHT.Store at 20º to 25ºC (68º to 77ºF),excursions permitted to 15º to 30ºC(59º to 86ºF) [See USP ControlledRoom Temperature]. Adequate and well-controlled studies have not been done in pregnant women. Hematocrit, reticulocyte count, vitamin B12, folate and iron levels should be obtained prior to treatment. Events, Hematological: Polycythemia vera Cyanocobalamin injection will supply you with enough vitamin B 12 only as long as you receive injections regularly. Vitamin B12 is known to be excreted in human milk. The molecular weight is 1355.4 If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader.
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