FDA will post its own background review of each substance at least two business days before the meeting
Isolated allergy cases are reported, with some successfully treated by desensitisation.70 Transient hypokalaemia during initial B 12 treatment in individuals with severe anaemia is usually mild and without clinical consequences.7 Contraindications Preparations containing benzylalcohol are contraindicated for use in children and pregnant women.71 Cyanocobalamin is associated with worsening of visual problems, and is therefore contraindicated in people with the mitochondrial disorder Lebers hereditary optic neuropathy.72 Cyanocobalamin (but not hydroxocobalamin) is also contraindicated in renal insufficiency.73 Tips for safer prescribing Pregnancy and breastfeeding Continued or new B12 therapy of women with deficiency during pregnancy and lactation is mandatory and safe.74 B 12 deficiency increases the risk of adverse pregnancy outcomes, including early pregnancy loss, neural tube defects, pre-eclampsia, preterm birth, and low birth weight,7576 as well as insulin resistance and adiposity.77 It also may lead to neurological complications in newborns, such as hypotonia, failure to thrive, central apnoeas, and seizures.7879 Children Evidence based treatment advice on treatment in children is lacking
03/24 PRINCIPAL DISPLAY PANEL - 10 mL Vial Box PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Cyanocobalamin Injection, USP 10,000 mcg/10 mL (1,000 mcg/mL) NDC 6968011399 10 x 10 mL MULTIPLE DOSE VIALS For Intramuscular or Subcutaneous Use Only Each mL contains: Cyanocobalamin 1000 mcg, Benzyl Alcohol 1.5%, Sodium Chloride 0.9%, Water for Injection q.s
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Do take as directed by your healthcare provider
