Palafer®

Produit de santé naturel homologué au Canada

Titulaire: Bausch & Lomb Inc.
NPN ou DIN-HM: 01923420
Statut: Licence active
Date de licence: 29 septembre 2008
Date de révision: 7 février 2024
Forme: Capsule
Voie d'administration: Orale
Type de demande: DIN de transition

Si ce produit était vendu en France

Aucun point relevé par les règles que nous appliquons.

Une quantité quotidienne est calculée uniquement pour une posologie adulte orale explicite, exprimée par jour et dans une unité solide correspondant à la forme du produit. Les unités ambiguës, liquides, poudres et doses pédiatriques ne sont pas extrapolées. Une quantité non calculée n'est pas comparée aux limites de dose. Cette analyse ne constitue pas une autorisation de vente en France ni une évaluation de sécurité ou d'efficacité.

Composition

Ingrédient médicinal et source	Par unité posologique, selon la source	Par jour au plus, adulte
fumarate ferreux Source : Fumarate ferreux Puissance : 100 mg Iron	300 mg	Non calculée

Ingrédient médicinal et source

Par unité posologique, selon la source

Par jour au plus, adulte

fumarate ferreux

Source : Fumarate ferreux

Puissance : 100 mg Iron

300 mg

Non calculée

Ingrédients non médicinaux

Rouge FD & C #3, Saccharose, Jaune D & C No. 10, Eau purifiée, sulfate sodique de lauryle, Talc, Gélatine, Lactose Monohydrate, Dioxyde de titane, FD&C Yellow 6, FD&C Red No. 2, Povidone, Dioxyde de silicium

Doses recommandées au Canada

Population	Âge	Quantité par prise	Fréquence
Adultes	Non précisée	1 Capsule	Non précisée
Enfants	minimum : 12 ans	1 Capsule	Non précisée

Usages autorisés au Canada

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.

Un usage autorisé au Canada n'est pas une allégation de santé autorisée dans l'Union européenne. Consultez le registre des allégations de santé.

Mises en garde au Canada

Contre-indications
N/A Additional information for health care practitioners: Hemosiderosis, hemochromatosis. Iron compounds are also contraindicated in the treatment of hemolytic anemias unless an iron-deficient state also exists, since storage of iron with a possible exogenous hemosiderosis can result.
Précautions et mises en garde
Keep out of reach of children. This package contains enough drug to seriously harm a child. Additional information for health care practitioners: Where anemia exists, its nature should be established and underlying causes determined. Prolonged administration of iron should be avoided except in patients with continued bleeding or repeated pregnancies. In infants, large chronic doses of iron may so interfere with the assimilation of phosphorous as to cause severe rickets. Orally administered iron salts may aggravate existing disorders, such as peptic ulcer, regional enteritis and ulcerative colitis. They may not be absorbed in patients with steatorrhea and those who have had a partial gastrectomy. Before initiating parenteral iron therapy, it is advisable to give test doses to help detect sensitivity. Iron overload can occur in patients given an excess of parenteral iron, as well as those with hemoglobinopathies or other refractory anemias which might be erroneously diagnosed as iron-deficiency anemia. Do not administer oral iron preparations concomitantly with parenteral iron. Iron with tetracyclines binds in equal molecular ratio thus preventing absorption of tetracyclines. Warn patients that iron is toxic when overdoses are ingested by children. Severe reactions, including fatalities, have resulted. Concomitant administration of antacids containing aluminum and magnesium salts may impair the absorption of iron. Do not use except under the care of a physician. Consult a health care practitioner prior to use if you are pregnant or breastfeeding. Consult a health care practitioner prior to use if you have a peptic ulcer, regional enteritis or ulcerative colitis.
Effets indésirables connus
Some people may experience constipation, diarrhea and/or vomiting. Additional information for health care practitioners: Oral ingestion of iron preparations may be associated with gastrointestinal discomfort (such as nausea) and dose-related bowel effects(such as constipation, diarrhea, and/or vomiting). Untoward effects usually subside with continuation of therapy or by iron ingestion with or after meals. Parenteral iron administrations can cause nausea, vomiting, and such acute allergic reactions as chills and fever, arthralgia, urticaria, and asthma. Occasional pain and staining of the skin at the site of injection may occur. Severe anaphylactoid reactions with some deaths have been reported in the literature. Although i.m. administration of iron dextran injections has caused sarcoma in laboratory animals, included malignancy in man has never been observed.