DIALINE LOW CALCIUM PERITONEAL DIALYSIS SOLUTION WITH 4.25 % DEXSTROSE

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

CALCIUM CHLORIDE; GLUCOSE HYDROUS; LACTIC ACID AS SODIUM; MAGNESIUM CHLORIDE; SODIUM CHLORIDE

MAH:

TEVA MEDICAL LTD

ATC_code:

B05XA31

pharmaceutical_form:

SOLUTION FOR PERITONEAL DIALYSIS

composition:

GLUCOSE HYDROUS 4.25 G / 100 ML; MAGNESIUM CHLORIDE 5.08 MG / 100 ML; SODIUM CHLORIDE 538 MG / 100 ML; LACTIC ACID AS SODIUM 448 MG / 100 ML; CALCIUM CHLORIDE 18.3 MG / 100 ML

administration_route:

PERITONEAL DIALYSIS

prescription_type:

Required

manufactured_by:

TEVA MEDICAL LTD, ISRAEL

therapeutic_group:

ELECTROLYTES IN COMBINATION WITH OTHER DRUGS

therapeutic_area:

ELECTROLYTES IN COMBINATION WITH OTHER DRUGS

therapeutic_indication:

For use in chronic renal failure patient being maintained in peritoneal dialysis.

authorization_date:

2012-05-31

SPC

DIALINE
® LOW CALCIUM PERITONEAL DIALYSIS SOLUTIONS
(2.5% MEQ/L CALCIUM)
DIALINE
® LOW CALCIUM PERITONEAL DIALYSIS SOLUTION WITH 1.5% DEXTROSE.
DIALINE
® LOW CALCIUM PERITONEAL DIALYSIS SOLUTION WITH 2.5% DEXTROSE.
DIALINE
® LOW CALCIUM PERITONEAL DIALYSIS SOLUTION WITH 4.25% DEXTROSE.
FOR PERITONEAL DIALYSIS
FOR INTRAPERITONEAL ADMINISTRATION ONLY
DESCRIPTION
DIALINE Low Calcium peritoneal dialysis solutions are sterile,
nonpyrogenic solutions in plastic containers for intraperitoneal
administration only. They contain no bacteriostatic
or antimicrobial agents or added buffers.
Composition, calculated osmolarity, pH and ionic concentrations are
shown in Table 1.
Potassium is omitted from peritoneal dialysis solutions because
dialysis may be performed to correct hyperkalemia. In situations in
which there is a normal serum potassium
level or hypokalemia, the addition of potassium chloride (up to a
concentration of 4 mEq/L) may be indicated to prevent severe
hypokalemia.
ADDITION OF POTASSIUM CHLORIDE SHOULD BE MADE AFTER CAREFUL EVALUATION
OF SERUM AND TOTAL BODY POTASSIUM AND ONLY UNDER THE DIRECTION OF A
PHYSICIAN. Frequent
monitoring of serum electrolytes is indicated.
In some patients calcium carbonate is used as a phosphate binder.
Because serum calcium levels have been observed to be elevated in
these patients (Slatopolsky et al.
1986), the calcium concentration of DIALINE Low Calcium peritoneal
dialysis solutions has been appropriately reduced to 2.5 mEq/L. Serum
calcium levels should be
monitored and if low, the amount of oral calcium carbonate phosphate
binder may be increased or peritoneal dialysis solutions containing
higher calcium concentrations may
be used. If serum calcium levels rise, adjustments to the dosage of
the calcium carbonate phosphate binder and/or vitamin D analogs should
be considered by the physician.
Because average plasma magnesium levels in some chronic CAPD patients
have been observed to be elevated (Nolph et al. 1981), the magnesium
concentration of this
formulation has been re