DIANEAL PD-2 Peritoneal Dialysis with 2.5% w/v Glucose Solution Freeline Solo Twin Bag

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

glucose monohydrate, Quantity: 25 g/L; sodium chloride, Quantity: 5.38 g/L; sodium lactate, Quantity: 4.48 g/L; calcium chloride dihydrate, Quantity: 257 mg/L; magnesium chloride hexahydrate, Quantity: 50.8 mg/L

Dostopno od:

Vantive Pty Ltd

INN (mednarodno ime):

calcium chloride dihydrate,glucose monohydrate,magnesium chloride hexahydrate,sodium chloride,sodium lactate

Farmacevtska oblika:

Solution, irrigation

Sestava:

Excipient Ingredients: hydrochloric acid; water for injections

Pot uporabe:

Intraperitoneal

Enote v paketu:

2L Bag AHB9607, 2.5L Bag AHB9611

Tip zastaranja:

Not scheduled. Not considered by committee

Terapevtske indikacije:

Dianeal low calcium peritoneal dialysis solution is indicated for use in chronic renal failure patients being maintained on continuous ambulatory peritoneal dialysis or intermittent peritoneal dialysis and/or automated peritoneal dialysis and can also be used for acute renal failure.

Povzetek izdelek:

Visual Identification: Clear slightly coloured solution; Container Type: Bag; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

1995-06-21

Navodilo za uporabo

DIANEAL PERITONEAL DIALYSIS SOLUTION
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common questions about DIANEAL PERITONEAL
DIALYSIS SOLUTION.
It does not contain all of the available information. All medicines
have risks and benefits.
Your doctor has weighed the risks of you using DIANEAL PERITONEAL
DIALYSIS SOLUTION
against the benefit they expect it will have for you.
It does not take the place of talking to your doctor or pharmacist.
If you have any concerns about taking this medicine, ask your doctor
or pharmacist.
WHAT DIANEAL PERITONEAL DIALYSIS SOLUTION IS USED FOR?
Kidney failure occurs when the kidneys can no longer function
adequately and a person’s
survival depends upon either a kidney transplant or renal replacement
therapy, including
dialysis.
Dialysis is the process of filtering or cleansing the blood of waste
products and excess
water and removing them from the body. There are two methods of
dialysis treatment -
haemodialysis and peritoneal dialysis. Both employ specially
formulated solutions to
perform blood cleansing.
Peritoneal dialysis uses the body's own peritoneal or abdominal
membrane as a filter to
cleanse the blood. The peritoneal membrane lines the peritoneal
cavity. A sterile tube
called a catheter is inserted by a simple surgical procedure through
the wall of your
abdominal cavity. This provides an opening through which the dialysis
solution can be
infused into the abdominal cavity. Waste products pass from the blood
stream, through the
peritoneal membrane and into the dialysis solution. Blood cells and
large molecules such
as proteins are retained since they are too large to pass through the
membrane. The used
dialysis solution is periodically drained from the abdominal cavity
and replaced with fresh
solution, usually 3-4 times a day.
Peritoneal dialysis procedures are easy to learn but it is imperative
that you adhere to the
procedure taught by your health care professional.
There are two ways of performing peritoneal dialysis: Continuous
Ambulat

Lastnosti izdelka

DIANEAL
Peritoneal Dialysis Solutions
Version 1.2
1 of 12
AUSTRALIAN PRODUCT INFORMATION –
DIANEAL PERITONEAL DIALYSIS SOLUTIONS (SODIUM CHLORIDE, GLUCOSE MONOHYDRATE,
SODIUM LACTATE, MAGNESIUM CHLORIDE
HEXAHYDRATE AND CALCIUM CHLORIDE DIHYDRATE)
1
NAME OF THE MEDICINE
Sodium chloride, glucose monohydrate, sodium lactate, magnesium
chloride hexahydrate and
calcium chloride dihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DIANEAL PD-2, PD-4 and 1 mmol/L Calcium Peritoneal Dialysis Solutions
are sterile,
nonpyrogenic and contain no bacteriostatic or antimicrobial agents or
added buffers.
The compositions of the DIANEAL Peritoneal Dialysis (PD) Solutions are
provided in:
•
Table 1 - Ingredient concentration (mg/L or g/L) and
•
Table 2 – Ingredient concentration (mmol/L) and Osmolarity.
TABLE 1: DIANEAL PD SOLUTION - INGREDIENT CONCENTRATION (MG/L OR G/L)
INGREDIENTS
DIANEAL
1 MMOL/L CALCIUM
DIANEAL
PD-4
DIANEAL
PD-2
with Glucose
monohydrate
with Glucose
monohydrate
with Glucose
monohydrate
0.55% 1.5% 2.5% 4.25%
0.55% 1.5% 2.5% 4.25%
0.55%
1.5% 2.5%
4.25%
GLUCOSE
MONOHYDRATE
(G/L)
5.5
15
25
42.5
5.5
15
25
42.5
5.5
15
25
42.5
SODIUM
CHLORIDE
(G/L)
5.38
5.38
5.38
SODIUM
LACTATE
(G/L)
4.48
4.48
4.48
MAGNESIUM
CHLORIDE
HEXAHYDRATE
(MG/L)
50.8
50.8
50.8
CALCIUM
CHLORIDE
DIHYDRATE
(MG/L)
147
183
257
WATER FOR
INJECTIONS
QS
QS
QS
DIANEAL
Peritoneal Dialysis Solutions
Version 1.2
2 of 12
TABLE 2: DIANEAL PD SOLUTION - INGREDIENT CONCENTRATION (MMOL/L) AND
OSMOLARITY
DIANEAL
1 MMOL/L CALCIUM
DIANEAL
PD-4
DIANEAL
PD-2
with Glucose
monohydrate
with Glucose
monohydrate
with Glucose
monohydrate
0.55%
1.5%
2.5%
4.25%
0.55%
1.5%
2.5%
4.25%
0.55%
1.5%
2.5%
4.25%
GLUCOSE
(MMOL/L)
28
76
126
214
28
76
126
214
28
76
126
214
SODIUM
(MMOL/L)
132
132
132
MAGNESIUM
(MMOL/L)
0.25
0.25
0.25
CALCIUM
(MMOL/L)
1
1.25
1.75
CHLORIDE
(MMOL/L)
95
95
96
LACTATE
(MMOL/L)
40
40
40
APPROXIMATE
OSMOLARITY
(MOSMOL/L)
296
344
394
482
297
345
395
483
298
346
396
485
Potassium is omitted from DIANEAL Solutions because dialysis may be
performed t