PHOSLO TABLETS

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

CALCIUM ACETATE

Saatavilla:

FRESENIUS MEDICAL CARE NORTH AMERICA

ATC-koodi:

V03AE

INN (Kansainvälinen yleisnimi):

DRUGS FOR TREATMENT OF HYPERKALEMIA AND HYPERPHOSPHATEMIA

Annos:

667MG

Lääkemuoto:

TABLET

Koostumus:

CALCIUM ACETATE 667MG

Antoreitti:

ORAL

Kpl paketissa:

200

Prescription tyyppi:

Prescription

Terapeuttinen alue:

PHOSPHATE-REMOVING AGENTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0123586005; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2013-07-29

Valmisteyhteenveto

PRODUCT MONOGRAPH
PR
PHOSLO
®
(Calcium Acetate)
Oral Tablets
Phosphate Binder
Manufactured for:
Fresenius Medical Care North America
Waltham, MA 02451 USA
Distributed by:
Fresenius Medical Care Canada, Inc
Richmond Hill, ON, L4B 4W6 Canada
1-888-709-4411
Date of Preparation: February 20, 2007
Control Number: 112003
Page 1 of 15
NAME OF DRUG
PhosLo
Calcium Acetate
667 mg Tablets
THERAPEUTIC CLASSIFICATION
Phosphate Binder
ACTIONS AND CLINICAL PHARMACOLOGY
When taken with meals, PhosLo (calcium acetate) combines with dietary
phosphate to
form insoluble calcium phosphate, which is excreted in the feces.
PhosLo is highly
soluble at neutral pH, making the calcium readily available for
binding to phosphate in
the proximal small intestine. Calcium acetate is a more efficient
phosphate binder than
other calcium salts. When phosphate binding in the proximal small
intestinal lumen
occurs, the calcium available for absorption decreases, thus reducing
the risk of
hypercalcemia in these patients.
The absorption of phosphorus plays a critical role in the development
of metabolic bone
diseases in patients with chronic renal failure. The retention of
phosphate plays a pivotal
role in causing secondary hyperparathyroidism associated with
osteodystrophy and soft
tissue calcification. The majority of patients with advanced renal
insufficiency
(glomerular filtration rate less than 30 mL/min) exhibit phosphate
retention with
hyperphosphatemia.
The rate of removal of phosphate by dietary manipulation or by
dialysis is insufficient to
prevent hyperphosphatemia in most dialysis patients. Dialysis patients
absorb 40% to
80% of dietary phosphorus. Therefore, the fraction of dietary
phosphate absorbed from
the diet needs to be reduced. Phosphate binders in most renal failure
patients on
maintenance dialysis are effective in accomplishing that.
INDICATIONS AND CLINICAL USE
PhosLo (calcium acetate) is indicated for the control of
hyperphosphatemia in end stage
renal failure.
Page 2 of 15
CONTRAINDICATIONS
PhosLo (calcium acetate) is contrai