Physioneal 40 Glucose 3.86% solution for peritoneal dialysis 2litre single two-chamber bags with luer connector

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium lactate; Glucose anhydrous; Sodium chloride; Magnesium chloride hexahydrate; Calcium chloride dihydrate; Sodium bicarbonate

Available from:

Baxter Healthcare Ltd

ATC code:

B05DA

INN (International Name):

Sodium lactate; Glucose anhydrous; Sodium chloride; Magnesium chloride hexahydrate; Calcium chloride dihydrate; Sodium bicarbonate

Dosage:

1.68gram/1litre ; 38.6gram/1litre ; 5.38gram/1litre ; 51mg/1litre ; 184mg/1litre ; 2.1gram/1litre

Pharmaceutical form:

Solution for peritoneal dialysis

Administration route:

Intraperitoneal

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF:

Summary of Product characteristics

OBJECT 1
PHYSIONEAL 40 GLUCOSE 3.86% W/V / 38.6
MG/ML SOLUTION FOR PERITONEAL DIALYSIS
Summary of Product Characteristics Updated 21-Mar-2018 | Baxter
Healthcare Ltd
1. Name of the medicinal product
PHYSIONEAL 40 Glucose 3.86% w/v / 38.6 mg/ml
Solution for peritoneal dialysis
2. Qualitative and quantitative composition
Before mixing
1000 ML OF ELECTROLYTE SOLUTION (SMALL CHAMBER ″A″)
Active substances:
Glucose monohydrate
Equivalent to Anhydrous glucose
Calcium chloride dihydrate
Magnesium chloride hexahydrate
117.14 g
106.5 g
0.507 g
0.140 g
1000 ML OF BUFFER SOLUTION (LARGE CHAMBER ″B″)
Active substances:
Sodium chloride
Sodium bicarbonate
Sodium (S)-lactate solution
8.43 g
3.29 g
2.63 g
After mixing
1000 ML OF THE MIXED SOLUTION CONTAINS:
Active substances:
Glucose monohydrate
Equivalent to Anhydrous glucose
Sodium chloride
42.50 g
38.6 g
5.38 g
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium bicarbonate
Sodium (S)-lactate solution
0.184 g
0.051 g
2.10 g
1.68 g
1000 ml of final solution after mixing corresponds to 362.5 ml of
solution A and 637.5 ml of solution B.
COMPOSITION OF THE FINAL SOLUTION AFTER MIXING IN MMOL/L
Glucose anhydrous (C
6
H
12
O
6
)
Na+
Ca
++
Mg
++
Cl
-
HCO
3
-
C
3
H
5
O
3
-
214 mmol/l
132 mmol/l
1.25 mmol/l
0.25 mmol/l
95 mmol/l
25 mmol/l
15 mmol/l
For the full list of excipients, see section 6.1.
The number '40' in the name specifies the buffer concentration of the
solution (15 mmol/l of lactate + 25
mmol/l of bicarbonate = 40 mmol/l).
3. Pharmaceutical form
Solution for peritoneal dialysis.
Sterile, clear, colourless solution.
The pH of the final solution is 7.4.
Osmolarity (MOSMOL/L)
483
4. Clinical particulars
4.1 Therapeutic indications
PHYSIONEAL 40 is indicated whenever peritoneal dialysis is employed,
including:
• Acute and chronic renal failure;
• Severe water retention;
• Severe electrolyte imbalance;
• Drug intoxication with dialysable substances, when a more adequate
therapeutic alternative is not
available.
PHYSIONEAL 40 bicarbonate/lactate ba