Nefrosol with 4 mmol/l Potassium solution for haemofiltration

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

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

Dostupné z:

B. Braun Avitum AG

ATC kód:

B05ZB

INN (Medzinárodný Name):

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

Dávkovanie:

4 millimole(s)/litre

Forma lieku:

Solution for haemofiltration

Typ predpisu:

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

Terapeutické oblasti:

Hemofiltrates

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2017-05-19

Príbalový leták

– 2 –
Package leaflet: Information for the patient
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 4 mmol/l Potassium is and what it is used for
2.
What you need to know before you are given Nefrosol with
4 mmol/l Potassium
3.
How to use Nefrosol with 4 mmol/l Potassium
4.
Possible side effects
5.
How to store Nefrosol with 4 mmol/l Potassium
6.
Contents of the pack and other information
1. WHAT NEFROSOL WITH 4 MMOL/L POTASSIUM IS AND WHAT IT IS
USED FOR
Nefrosol with 4 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 4 MMOL/L POTASSIUM
NEFROSOL WITH 4 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 bleeding because you receive drugs to
prevent blood clotting

Súhrn charakteristických

Health Products Regulatory Authority
18 January 2021
CRN00C3ZN
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nefrosol with 4 mmol/l Potassium solution for haemofiltration
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SMALL CHAMBER
ELECTROLYTE SOLUTION
LARGE CHAMBER
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
1.49 g
2.68 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
+
20.0
36.0
—
—
Ca
2+
7.5
13.5
—
—
Mg
2+
2.5
4.5
—
—
Cl
-
95.0
171
470
106
HCO
3
-
—
—
190
42.8
Theoretical osmolarity [mOsm/l]
347
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
+ 4.0
Ca
2+
1.5
Mg
2+
0.5
Cl
-
113
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: 300 mOsm/l
pH: 7.0‑8.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Health Products Regulatory Authority
18 January 2021
CRN00C3ZN
Page 2 of 7
The ready-to-use solution is indicated for use in patients with acute
renal failure of any cause requiring continuous
haemofiltration.
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 b