Nefrosol with 2 mmol/l Potassium solution for haemofiltration

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Sodium chloride ph.eur.; Sodium hydrogen carbonate; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Glucose monohydrate; Potassium chloride

から入手可能:

B. Braun Avitum AG

ATCコード:

B05ZB

INN（国際名）:

Sodium chloride ph.eur.; Sodium hydrogen carbonate; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Glucose monohydrate; Potassium chloride

投薬量:

2 millimole(s)/litre

医薬品形態:

Solution for haemofiltration

処方タイプ:

Product subject to prescription which may not be renewed (A)

治療領域:

Hemofiltrates

認証ステータス:

Marketed

承認日:

2017-05-19

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEFROSOL WITH 2 MMOL/L POTASSIUM SOLUTION FOR HAEMOFILTRATION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nefrosol with 2 mmol/l Potassium is and what it is used for
2.
What you need to know before you are given Nefrosol with 2 mmol/l
Potassium
3.
How to use Nefrosol with 2 mmol/l Potassium
4.
Possible side effects
5.
How to store Nefrosol with 2 mmol/l Potassium
6.
Contents of the pack and other information
1.
WHAT NEFROSOL WITH 2 MMOL/L POTASSIUM IS AND WHAT IT IS USED FOR
Nefrosol with 2 mmol/l Potassium is a solution for haemofiltration. It
is intended for use in patients with
acute kidney failure, when the kidneys are no longer able to remove
waste products from the blood.
Continuous haemofiltration is a procedure which is used to remove the
waste products from the body which
would otherwise be excreted via the kidneys in urine. The solution
corrects the fluid balance and ensures
that salt (electrolyte) losses are replaced following treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NEFROSOL WITH 2 MMOL/L
POTASSIUM
NEFROSOL WITH 2 MMOL/L POTASSIUM SHOULD NOT BE GIVEN IF
-
you have an abnormally low blood potassium level (hypokalaemia)
-
your blood contains abnormally low acid levels (metabolic alkalosis).
The haemofiltration procedure itself should not be used if
-
you have kidney failure in combination with a very high metabolic
turnover (hypercatabolic state), in
which situation the accumulation of waste products in your body can no
longer be corrected by
haemofiltration
-
you have poor blood flow from the site of insertion of the cannula in
the vein
-
you have a high risk of bleedin

製品の特徴

Health Products Regulatory Authority
18 January 2021
CRN00C3ZN
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nefrosol with 2 mmol/l Potassium solution for haemofiltration
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SMALL C HAMBER
ELECTROLYTE SOLUTION
LARGE C HAMBER
BICARBONATE SOLUTION
ACTIVE SUBSTANCES:
555 ML CONTAIN
PER
1000 ML
4445 ML CONTAIN
PER
1000 ML
Sodium chloride
2.34 g
4.21 g
27.47 g
6.18 g
Potassium chloride
0.74 g
1.34 g
—
—
Calcium chloride dihydrate
1.10 g
1.98 g
—
—
Magnesium chloride hexahydrate
0.51 g
0.91 g
—
—
Glucose monohydrate
equivalent to glucose anhydrous
5.49 g
5.0 g
9.90 g
9.0 g
—
—
Sodium hydrogen carbonate
—
—
15.96 g
3.59 g
ELECTROLYTES:
[MMOL/ CHAMBER] [MMOL/L]
[MMOL/ CHAMBER] [MMOL/L]
Na
+
40.0
72
660
149
K
+
10.0
18.0
—
—
Ca
2+
7.5
13.5
—
—
Mg
2+
2.5
4.5
—
—
Cl
-
85.0
153
470
106
HCO
3
-
—
—
190
42.8
Theoretical osmolarity [mOsm/l]
311
297
COMPOSITION OF THE READY-TO-USE SOLUTION FOR HAEMOFILTRATION AFTER
MIXING:
1000 ml ready-to-use solution for haemofiltration contain [mmol/l]:
Na
+
140
K
+ 2.0
Ca
2+
1.5
Mg
2+
0.5
Cl
-
111
HCO
3
-
35.0
Glucose anhydrous 5.6 (equiv. to 1.0 g)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for haemofiltration
Clear and colourless solution, free from visible particles
Theoretical osmolarity: 296 mOsm/l
pH: 7.0‑8.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The ready-to-use solution is indicated for use in patients with acute
renal failure of any cause requiring continuous
haemofiltration.
Health Products Regulatory Authority
18 January 2021
CRN00C3ZN
Page 2 of 7
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The use of solutions for haemofiltration in patients with acute renal
failure should be under the direction of a physician with
experience in using such treatment.
Posology
The filtration rate prescribed is dependent on the clinical status and
the body weight of the patient. Unless otherwise
prescribed, a filtration rate of 20‑25 ml/kg