FDA records indicate that there are no current recalls for this drug.
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Iron Polysaccharides Folic Acid Dha Recall
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS: Caution is recommended in patients with a history of bipolar illness. Mood elevation is possible in this population. Caution is also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group.
Folinic acid may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly formyl-THF and fluorouracil. Concomitant granulocytopenia and fever were present in some but not all of the patients. The concomitant use of formyl-THF with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study.35 Patients undergoing cancer treatment should consult their licensed medical practitioner for advice.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
PNV - Iron Polysaccharides/Folic Acid/DHA (29 mg-1 mg-200 mg) is a prescription multivitamin/ multimineral nutritional supplement with Omega-3 fatty acid indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. PNV - Iron Polysaccharides/Folic Acid/DHA (29 mg-1 mg-200 mg) is also beneficial in improving the nutritional status of women prior to conception.
Pedigree statement: This product is a prescription-folate with or without other dietary ingredients that - due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). As such, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) as required by pedigree reporting requirements and insurance-reimbursement applications.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION: PNV - Iron Polysaccharides/Folic Acid/DHA (29 mg-1 mg-200 mg) is a prescription prenatal/postnatal multivitamin/ multimineral nutritional supplement with Omega-3 fatty acid. PNV - Iron Polysaccharides/Folic Acid/DHA (29 mg-1 mg-200 mg) is an oblong shaped, dark blue colored softgel, imprinted with 230.
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Each PNV - Iron Polysaccharides/Folic Acid/DHA (29 mg-1 mg-200 mg) Softgel contains: |
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Vitamin A (as betacarotene) | 1,100 IU |
Vitamin C (as ascorbic acid) | 30 mg |
Vitamin D3 (as cholecalciferol) | 1,000 IU |
Vitamin E (as dl-alpha tocopheryl acetate) | 20 IU |
(Vitamin B1) (as thiamine mononitrate) | 1.6 mg |
Vitamin B2 (as riboflavin) | 1.8 mg |
Niacin (as niacinamide) | 15 mg |
Vitamin B6 (as pyridoxine HCI) | 2.5 mg |
Folic Acid (as pteroylglutamic acid) | 1 mg |
Vitamin B12 (as cyanocobalamin) | 12 mcg |
Iron (as polysaccharide iron complex) | 29 mg |
Iodine (as potassium iodide) | 150 mcg |
Magnesium (as magnesium oxide) | 20 mg |
Zinc (as zinc oxide) | 25 mg |
Copper (as cupric oxide) | 2 mg |
Omega 3 Fatty Acid: | |
DHA | 200 mg* |
Sources
Iron Polysaccharides Folic Acid Dha Manufacturers
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Virtus Pharmaceuticals Llc
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