Physioneal 35 Glucose 2.27% solution for peritoneal dialysis 2litre twin 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:

Vantive 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 ; 5.67gram/1litre ; 257mg/1litre ; 51mg/1litre ; 2.1gram/1litre ; 1.12gram/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: 05413760329482

Summary of Product characteristics

OBJECT 1
PHYSIONEAL 35 GLUCOSE 2.27% W/V / 22.7
MG/ML SOLUTION FOR PERITONEAL DIALYSIS
Summary of Product Characteristics Updated 21-Mar-2018 | Baxter
Healthcare Ltd
1. Name of the medicinal product
PHYSIONEAL 35 Glucose 2.27% w/v / 22.7 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
68.85 g
62.6 g
0.710 g
0.140 g
1000 ML OF BUFFER SOLUTION (LARGE CHAMBER ″B″)
Active substances:
Sodium chloride
Sodium bicarbonate
Sodium (S)-lactate solution
8.89 g
3.29 g
1.76 g
After mixing
1000 ML OF THE MIXED SOLUTION CONTAINS:
Active substances:
Glucose monohydrate
Equivalent to Anhydrous glucose
Sodium chloride
25.0 g
22.7 g
5.67 g
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium bicarbonate
Sodium (S)-lactate solution
0.257 g
0.051 g
2.10 g
1.12 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
-
126 mmol/l
132 mmol/l
1.75 mmol/l
0.25 mmol/l
101 mmol/l
25 mmol/l
10 mmol/l
For the full list of excipients, see section 6.1.
The number '35' in the name specifies the buffer concentration of the
solution (10 mmol/l of lactate + 25
mmol/l of bicarbonate = 35 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)
396
4. Clinical particulars
4.1 Therapeutic indications
PHYSIONEAL 35 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 35 bicarbonate/lactate base