Physioneal 40 Glucose 2.27% Clear-Flex solution for peritoneal dialysis 5litre single two-chamber bags with luer connector

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

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

Available from:

Baxter Healthcare Ltd

ATC code:

B05DA

INN (International Name):

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

Dosage:

22.7gram/1litre ; 5.38gram/1litre ; 184mg/1litre ; 51mg/1litre ; 2.1gram/1litre ; 1.68gram/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: ; GTIN: 05413760283180 55413760283185

Summary of Product characteristics

OBJECT 1
PHYSIONEAL 40 GLUCOSE 2.27% W/V / 22.7 MG/ML
CLEAR-FLEX, SOLUTION FOR PERITONEAL DIALYSIS.
Summary of Product Characteristics Updated 22-Feb-2017 | Baxter
Healthcare Ltd
1. Name of the medicinal product
PHYSIONEAL 40 Glucose 2.27% w/v / 22.7 mg/ml Clear-Flex,
Solution for peritoneal dialysis.
2. Qualitative and quantitative composition
Before mixing
1000 ML OF ELECTROLYTE SOLUTION (LARGE CHAMBER ″A″) CONTAINS:
Active substances:
Glucose monohydrate
equivalent to Glucose anhydrous
Calcium chloride dihydrate
Magnesium chloride hexahydrate
33.3 g
30.3 g
0.245 g
0.068 g
1000 ML OF BUFFER SOLUTION (SMALL CHAMBER ″B″) CONTAINS:
Active substances:
Sodium chloride
Sodium hydrogen carbonate
Sodium (S)-lactate solution equivalent to sodium (S)-
lactate
19.95 g
9.29 g
6.73 g
After mixing
1000 ML OF THE MIXED SOLUTION CONTAINS:
Active substances:
Glucose monohydrate
equivalent to Glucose anhydrous
25.0 g
22.7 g
Sodium chloride
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium hydrogen carbonate
Sodium (S)-lactate solution equivalent to sodium (S)-
lactate
5.38 g
0.184 g
0.051 g
2.10 g
1.68 g
1000 ml of final solution after mixing corresponds to 750 ml of
solution A and 250 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
-
126 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 hydrogen carbonate = 40 mmol/l).
3. Pharmaceutical form
Solution for peritoneal dialysis.
Sterile, clear, colourless solution.
The pH of the final solution is 7.4.
Osmolarity 395 mOsmol/l
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