Natural health product · DIN 01923420
Palafer®
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 September 29, 2008; licence last revised February 7, 2024.
- DIN
- 01923420
- Licence holder
- Bausch & Lomb Inc.Rochester, New York, United States
- Dosage form
- Capsule
- Route
- Oral
- Licensing route
- Transitional DIN
- First licensed
- September 29, 2008
- Licence last revised
- February 7, 2024
Medicinal ingredients
Per dosage unit, as licensed.
| Ingredient | Amount | Source and potency |
|---|---|---|
| Ferrous fumarate | 300 mg | Ferrous fumarate; 100 mg Iron |
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 deficiency and iron deficiency anaemia. Mineral supplement. A factor in the maintenance of good health. Helps to form red blood cells and helps in their proper function. Increased iron requirements as in childhood, adolescence, and pregnancy; blood losses overt or occult. Characterized microcytic hypochromic anemia; faulty iron absorption following gastrectomy; iron loss due to menstruation, sub-clinical iron deficiencies in adolescent girls due to precarious iron balance, and geriatrics. Additional information for health care practitioner: Palafer is well tolerated by most patients, however for patients sensitive to any form of iron: one capsule once a day with a meal is recommended, or as directed by your physician. Characterized iron deficiency anemia; 24 weeks minimum. In pregnancy, one capsule daily throughout gestation. Iron supplementation in clinical cases, 12 weeks minimum. 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 taken as presumptive evidence of poisoning; severe poisoning is usually associated with levels well above 1,000 mcg/100 mL. 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. 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; Sucrose; D&C Yellow #10; Purified water; Sodium lauryl sulfate; Talc; Gelatin; Lactose Monohydrate; Titanium dioxide; FD&C Yellow 6; FD&C Red No. 2; Povidone; Silicon dioxide