Physioneal 35 Glucose 2.27% Clear-Flex solution for peritoneal dialysis 5litre single two-chamber bags with luer connector

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

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

Dostopno od:

Vantive Ltd

Koda artikla:

B05DA

INN (mednarodno ime):

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

Odmerek:

22.7gram/1litre ; 5.67gram/1litre ; 257mg/1litre ; 51mg/1litre ; 2.1gram/1litre ; 1.12gram/1litre

Farmacevtska oblika:

Solution for peritoneal dialysis

Pot uporabe:

Intraperitoneal

Razred:

No Controlled Drug Status

Tip zastaranja:

Never Valid To Prescribe As A VMP

Povzetek izdelek:

BNF: ; GTIN: 05413760329499 55413760329494

Lastnosti izdelka

OBJECT 1
PHYSIONEAL 35 GLUCOSE 2.27% W/V / 22.7 MG/ML
CLEAR-FLEX, SOLUTION FOR PERITONEAL DIALYSIS.
Summary of Product Characteristics Updated 21-Feb-2017 | Baxter
Healthcare Ltd
1. Name of the medicinal product
PHYSIONEAL 35 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
0.343 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
21.12 g
9.29 g
4.48 g
After mixing
1000 ML OF THE MIXED SOLUTION CONTAINS:
Active substances:
Glucose monohydrate
equivalent to Glucose anhydrous
25.0 g
22.7 g
5.67 g
Sodium chloride
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium hydrogen carbonate
Sodium (S)-lactate solution equivalent to sodium (S)-
lactate
0.257 g
0.051 g
2.10 g
1.12 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
1.75 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 hydrogen carbonate = 35 mmol/l).
3. Pharmaceutical form
Solution for peritoneal dialysis.
Sterile, clear, colourless solution.
The pH of the final solution is 7.4.
Osmolarity 396 mOsmol/l
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