Sodium Chloride 0.18% w/v Glucose 4%w/v Solution for infusion

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Sodium chloride; Glucose monohydrate

Beschikbaar vanaf:

MACO PHARMA

ATC-code:

B05BB; B05BB02

INN (Algemene Internationale Benaming):

Sodium chloride; Glucose monohydrate

Dosering:

0.18/4 percent weight/volume

farmaceutische vorm:

Solution for infusion

Prescription-type:

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

Therapeutisch gebied:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

Autorisatie-status:

Marketed

Autorisatie datum:

2019-01-07

Bijsluiter

NTS119A-01/2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
SODIUM CHLORIDE 0.18%
W
/
V GLUCOSE 4%
W
/
V
SOLUTION FOR INFUSION
SODIUM CHLORIDE AND GLUCOSE ANHYDROUS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE BEING 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 nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1.
What Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion
is and what it
is used for
2.
What you need to know before you are given Sodium Chloride 0.18%w/v
Glucose
4%w/v Solution for Infusion
3.
How Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion is
given
4.
Possible side effects
5.
How to store Sodium Chloride 0.18%w/v Glucose 4%w/v Solution
for Infusion
6.
Contents of the pack and other information
1. WHAT SODIUM CHLORIDE 0.18%
W
/
V GLUCOSE 4%
W
/
V SOLUTION FOR
INFUSION IS AND WHAT IT IS USED FOR
Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion is a
clear, colourless to
faintly straw-coloured solution of sodium chloride and glucose in
water. The solution is stored
in a sealed flexible plastic bag.
Glucose sodium chloride solution is given to replace fluid loss from
the body. Glucose is a
simple sugar, which provides a source of energy. Sodium chloride
(salt) helps to maintain the
correct balance of fluid in and around the body’s cells and tissues.
Glucose sodium chloride solution may be given alone but may be given
with other medicines
added.
You will be given glucose sodium chloride solution in hospital by a
doctor or nurse.
The solution should be used in children only in specialist paediatric
units under expert medical
supervision, to maintain the correct balance of fluids and salts.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SODIUM CHLORIDE
0.18%
W
/
V GLUCOSE 4%
W
/
V SOLUTION FOR INFUSION
YOU MUST NOT BE GIVEN

Productkenmerken

Health Products Regulatory Authority
16 January 2019
CRN008TZW
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.18% w/v Glucose 4%w/v Solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
0.18% w/v sodium chloride and 4% w/v anhydrous glucose (as glucose
monohydrate).
Active component
Per 500ml
Per 1000ml
Sodium chloride
0.9g
Na+ 15 mmol
Cl- 15 mmol
1.8g
Na+ 30 mmol
Cl- 30 mmol
Glucose
monohydrate
22.0g equivalent to
20.0g anhydrous
111 mmol
44.0g equivalent to
40.0g anhydrous
222 mmol
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Infusion
Sterile non-pyrogenic infusion solution, colourless to faintly
straw-coloured without
visible particles.
pH 3.5 - 6.5
Osmolality: 290mOsm/kg H
2
O (approx).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in prophylactic and replacement therapy requiring the use of
glucose and
sodium chloride.
Paediatric Population
This product should only be used in paediatric specialist settings
(such as renal,
hepatic and cardiac units, high dependency units and intensive care
units) for
intravenous fluid therapy requiring the use of 0.18% sodium chloride
and 4% glucose
to maintain fluid and electrolyte balance.
Health Products Regulatory Authority
16 January 2019
CRN008TZW
Page 2 of 8
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
The volume of glucose sodium chloride solution needed to replenish
fluid deficits
varies with age, body weight, complementary treatment and severity of
the clinical
condition. The dose and rate of administration are typically between
500ml and
3000ml per 24 hours but are subject to clinical and laboratory
assessment in each
case.
Paediatric Population
Use of 0.18% sodium chloride and 4% glucose should be restricted to
specialist
paediatric settings such as renal, hepatic and cardiac units, high
dependency units
and intensive care units.
The dosage depends on the age, weight, clinical and biological
(acid-base balance)
conditions of the patient, concomit