ApprovalTrail

Natural health product · DIN 01923455

Palafer® CF

Yes: licensed in Canada

The product licence is active. Whether the product is actually on the market is a separate, voluntary notice; the official record shows it.

Licence status Active; licensed March 27, 2009; licence last revised February 7, 2024.
DIN
01923455
Licence holder
Bausch & Lomb Inc.Rochester, New York, United States
Dosage form
Capsule
Route
Oral
Licensing route
Transitional DIN
First licensed
March 27, 2009
Licence last revised
February 7, 2024

Medicinal ingredients

Per dosage unit, as licensed.

IngredientAmount
Folate0.5 mg
Ferrous fumarate100 mg Iron300 mg
Vitamin C200 mg

What it is licensed for

The licence’s own wording. Directions, doses, cautions and warnings are on the official record and the label.

  • Iron therapy. For the prevention and treatment of iron and folic acid deficiencies. For the prevention and treatment of iron deficiency and iron deficiency anemia. Mineral supplement. Vitamin supplement. Helps reduce the risk of neural tube defects when taken daily prior to becoming pregnant and during early pregnancy. A factor in the maintenance of good health. Helps the body to metabolize proteins and fat. Helps in the development and maintenance of bones, cartilage, teeth and gums. Helps to form red blood cells and helps in their proper function. Helps in connective tissue formation and wound healing. An antioxidant for the maintenance of good health. Helps to prevent Vitamin C deficiency. Helps to prevent folate deficiency. Additional information for health care practitioners: Prophylactic administration of Palafer CF should be discontinued at term. Iron therapy alone should be administered after parturition. Iron poisoning is rare in adults but serious acute poisoning in children can result from ingestion of doses in excess of 1 g. Doses of 1 g should be considered as toxic in children and therapy instituted as soon as possible. Serum iron levels above 500 mcg/100 mL can be presumptive evidence of poisoning; severe poisoning is usually associated with levels well above 1000 mcg/100mL. Symptoms may occur within about 30 minutes or may be delayed several hours. They are largely those of gastrointestinal irritation and necrosis with vomiting, diarrhea, tarry stools, hematemesis, fast and weak pulse, lethargy, low blood pressure, coma and signs of peripheral circulatory collapse. There may be a transient period of apparent recovery after 4 to 6 hours followed by a second crisis characterized by cyanosis, pulmonary edema, circulatory collapse, convulsion, and coma may then occur followed by death in 12 to 48 hours. Treatment; Milk should be given immediately and vomiting induced. Eggs and milk should then be fed (to form Iron-protein complexes) until it is possible to perform gastric lavage with 1% sodium bicarbonate solution (to convert the iron to a less soluble form). Gastric lavage should not be performed after the first hour of iron ingestion because of the danger of perforation due to gastric necrosis. If an iron-chelating agent such as deferoxamine mesylate is available, it should be utilized. BAL (dimercaprol) should not be used because it may form a toxic complex. Measures to combat shock, dehydration, blood loss and respiratory failure may be necessary.

Non-medicinal ingredients

FD&C Red #3; Magnesium stearate; FD & C Yellow #6; Talc; Purified water; Lactose Monohydrate; D&C Yellow #10; Titanium dioxide; Sodium lauryl sulfate; Sucrose; Gelatin; Povidone; FD & C blue #1; FD&C Red No. 2; Silicon dioxide

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