Nefrosol solution for haemofiltration

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

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

Boleh didapati daripada:

B. Braun Avitum AG

Kod ATC:

B05ZB

INN (Nama Antarabangsa):

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

Dos:

.

Borang farmaseutikal:

Solution for haemofiltration

Jenis preskripsi:

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

Kawasan terapeutik:

Hemofiltrates

Status kebenaran:

Marketed

Tarikh kebenaran:

2017-05-19

Risalah maklumat

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEFROSOL 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 is and what it is used for
2.
What you need to know before you are given Nefrosol
3.
How to use Nefrosol
4.
Possible side effects
5.
How to store Nefrosol
6.
Contents of the pack and other information
1.
WHAT NEFROSOL IS AND WHAT IT IS USED FOR
Nefrosol 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
NEFROSOL 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 bleeding because you receive drugs to prevent
blood clotting (systemic
anticoagulation).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before you are given Nefrosol.
Before and during haemofiltration your blood

Ciri produk

Health Products Regulatory Authority
18 January 2021
CRN00C3ZN
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nefrosol 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
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
Ca
2+
7.5
13.5
—
—
Mg
2+
2.5
4.5
—
—
Cl
-
75.0
135
470
106
HCO
3
-
—
—
190
42.8
Theoretical osmolarity [mOsm/l]
275
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
Ca
2+
1.5
Mg
2+
0.5
Cl
-
109
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: 292 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 body weight per hour is
recommended for the removal of metabolic waste products
normally excret