PLASMALYTE 148 IN WATER SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

SODIUM CHLORIDE; SODIUM ACETATE; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE

Διαθέσιμο από:

BAXTER CORPORATION

Φαρμακολογική κατηγορία (ATC):

B05BB01

INN (Διεθνής Όνομα):

ELECTROLYTES

Δοσολογία:

526MG; 368MG; 502MG; 37MG; 30MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

SODIUM CHLORIDE 526MG; SODIUM ACETATE 368MG; SODIUM GLUCONATE 502MG; POTASSIUM CHLORIDE 37MG; MAGNESIUM CHLORIDE 30MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

1000ML

Τρόπος διάθεσης:

Ethical

Θεραπευτική περιοχή:

REPLACEMENT PREPARATIONS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0500064002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2017-12-04

Αρχείο Π.Χ.Π.

1
PLASMA-LYTE 148 (AN ELECTROLYTE SOLUTION) INJECTION/ PLASMA-LYTE A
(AN ELECTROLYTE SOLUTION) INJECTION
BAXTER
DESCRIPTION
PLASMA-LYTE 148 Injection/PLASMA-LYTE A Injection are sterile,
nonpyrogenic
intravenous solutions which contain no bacteriostatic or antimicrobial
agents or added buffers.
The composition, osmolarity and approx. pH of the individual solutions
are shown in Table 1.
Normal physiologic isotonicity range is approximately 280 – 310
mOsmol/litre. PLASMA-
LYTE 148 Injection/PLASMA-LYTE A Injection have an osmolarity of 294
mOsmol/litre.
Table 1
DIN
Size (mL)
Composition (g/L)
Osmolarity (mOsmol/L)
pH
Ionic Concentration (mmol/L)
Caloric Content (kcal/L)
Sodium Chloride, USP
Potassium Chloride, USP
Sodium Gluconate, USP
Sodium Acetate, USP
Magnesium Chloride, USP
Sodium
Potassium
Chloride
Magnesium
Calcium
Acetate
Gluconate
Lactate
Dextrose
PLASMA-
LYTE 148
Injection
(JB2534)
00260576 1000
5.26
0.37
5.02
3.68
0.30
294
6.0
(4.0 – 8.0)
140
5
98
1.5
0
27
23
0
0
15
PLASMA-
LYTE A
Injection
(JB2544)
02339358 1000
5.26
0.37
5.02
3.68
0.30
294
7.4
(4.0 – 8.0)
140
5
98
1.5
0
27
23
0
0
15
ACTIONS
PLASMA-LYTE 148 Injection/PLASMA-LYTE A Injection are a source of
water for hydration
and provide electrolytes. Both are capable of inducing diuresis
depending on the clinical
conditions of the patient. See Table 1 for ionic concentrations of
PLASMA-LYTE 148
Injection/PLASMA-LYTE A Injection.
PLASMA-LYTE 148 Injection/PLASMA-LYTE A Injection both contain acetate
and gluconate
anions which produce a metabolic alkalinizing effect. These anions are
metabolized in the liver
to glycogen, and ultimately to carbon dioxide and water, which
requires the consumption of
hydrogen cations.
INDICATIONS
PLASMA-LYTE 148 Injection/PLASMA-LYTE A Injection are indicated for
volume
replacement, as a source of water and electrolytes, and as an
alkalinizing agent.
2
CONTRAINDICATIONS
PLASMA-LYTE 148 Injection/PLASMA-LYTE A Injection are contraindicated
in patients with
a known hypersensitivity to the product. [See WARNINGS AND
PREC