Paedisol Solution for Infusion

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium acetate trihydrate ; Glucose monohydrate

Beszerezhető a:

Fresenius Kabi Deutschland GmbH

ATC-kód:

B05BB; B05BB02

INN (nemzetközi neve):

Sodium chloride; Potassium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium acetate trihydrate ; Glucose monohydrate

Gyógyszerészeti forma:

Solution for infusion

Terápiás terület:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

Engedélyezési státusz:

Not marketed

Engedély dátuma:

2016-09-16

Betegtájékoztató

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PAEDISOL SOLUTION FOR INFUSION
(Sodium chloride, potassium chloride, calcium chloride dihydrate,
magnesium
chloride hexahydrate, sodium acetate trihydrate, and glucose
monohydrate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Paedisol is and what it is used for
2.
What you need to know before you use Paedisol
3.
How to use Paedisol
4.
Possible side effects
5.
How to store Paedisol
6.
Contents of the pack and other information
1.
WHAT PAEDISOL IS AND WHAT IT IS USED FOR
Paedisol is a solution for intravenous infusion (into a vein). It
contains minerals called
electrolytes that affect the amount of water in your body and other
important processes. It also
contains carbohydrates.
Paedisol is used in new-born babies (0 to ≤28 days), babies (28 days
to ≤2 years), children (2 to
≤12 years) and adolescents (12 to ≤14 years) as follows:
•
It helps to restore fluid levels and the normal electrolyte (salt)
balance after an operation. It
also contains glucose which provides a source of energy.
•
It acts as a plasma volume substitute that is used to restore the
blood volume.
•
It helps to restore fluid and electrolyte deficiencies.
•
It is used as a carrier solution for other electrolytes and medicinal
products.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PAEDISOL
DO NOT USE PAEDISOL:
•
if your child is allergic (hypersensitive) to sodium chloride,
potassium chloride, calcium
chloride, magnesium chloride, sodium acetate, glucose or any of the
other ingredients of this
medicine (listed in section 6).
•
for premature neonates and neonates (≤28 days of age): Your child
must not rec

Termékjellemzők

Health Products Regulatory Authority
22 September 2023
CRN00DKY6
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paedisol Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of Paedisol solution for infusion contains:
Sodium chloride
6.429 mg
Potassium chloride
0.298 mg
Calcium chloride dihydrate
0.147 mg
Magnesium chloride hexahydrate
0.203 mg
Sodium acetate trihydrate
4.082 mg
Glucose monohydrate
(equivalent to Glucose 10.0 mg)
11.0 mg
equivalent to:
Na
+
140 mmol/l;
K
+
4 mmol/l;
Ca
2+
1 mmol/l;
Mg
2+
1 mmol/l;
Cl
–
118 mmol/l;
Acetate ions
30 mmol/l;
Glucose
55.5 mmol/l
Total cation/anion content 148 mval/l each, glucose 10 mg/ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
A clear, colourless to slightly yellow aqueous solution.
pH: 5.3–5.7
Theoretical osmolarity: 351 mOsmol/l
Titration acidity: to pH 7.4 ≤ 5 mmol/l
Energy content: 168 kJ/l (40 kcal/l)
Carbohydrate content: 10 g/l
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paedisol is indicated for paediatric patients such as neonates (0 to
≤28 days), infants (28 days to ≤2 years), children (2 to ≤12
years), and adolescents (12 to ≤14 years) as follows:
– Perioperative plasma-isotonic fluid and electrolyte replacement
with partial coverage of carbohydrate requirements,
– Short-term intravascular volume replacement,
– Treatment of isotonic dehydration,
– Use as carrier solution for compatible electrolyte concentrates
and medicinal products.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Health Products Regulatory Authority
22 September 2023
CRN00DKY6
Page 2 of 6
Posology
_Paediatric population_
The dosage in perioperative intravenous infusion therapy depends on
the fluid, electrolyte, and glucose requirements:
During the first hour e.g. 10 – 20 ml/kg/hr, and thereafter for
regulation of the infusion rate according to basic and correction
requirements with monitoring of relevant cardiovascular and laboratory
parameters.
For fluid re