Sodium Chloride 0.45 % w/v and Glucose 5.0 % w/v Solution for Infusion BP

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Sodium chloride ; Glucose

Tillgänglig från:

Baxter Healthcare Limited

ATC-kod:

B05BB; B05BB02

INN (International namn):

Sodium chloride ; Glucose

Dos:

0.45/5 percent weight/volume

Läkemedelsform:

Solution for infusion

Receptbelagda typ:

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

Terapiområde:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

Bemyndigande status:

Marketed

Tillstånd datum:

2013-05-03

Bipacksedel

TH-30-01-807
1
Package leaflet: information for the user
Sodium Chloride 0.45% w/v and Glucose 5.0% w/v
Solution for Infusion BP
Active substances: sodium chloride, glucose.
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 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.
This medicine is called Sodium Chloride 0.45%
w/v and Glucose 5.0% w/v Solution for Infusion BP,
but will be referred to as Sodium Chloride 0.45 &
Glucose 5.0 Infusion throughout the remainder of
this leaflet.
What is in this leaflet:
1.
What Sodium Chloride 0.45 & Glucose 5.0
Infusion is and what it is used for
2.
What you need to know before you are
given Sodium Chloride 0.45 & Glucose 5.0
Infusion
3.
How you will be given Sodium Chloride
0.45 & Glucose 5.0 Infusion
4.
Possible side effects
5.
How to store Sodium Chloride 0.45 &
Glucose 5.0 Infusion
6.
Contents of the pack and other information
1. What Sodium Chloride 0.45 &
Glucose 5.0 Infusion is and what
it is used for
Sodium Chloride 0.45 & Glucose 5.0 Infusion is a
solution of the following substances in
water:
•
sugar (glucose)
•
sodium chloride (salt).
Glucose is one of the body’s sources of energy.
This solution for infusion provides 200 kilocalories
per litre.
Sodium and chloride are chemical substances
found in the blood.
Sodium Chloride 0.45 & Glucose 5.0 Infusion is
used:
•
as a source of carbohydrate (sugar).
•
to treat a loss of body water (dehydration) and
chemicals (e.g. by heavy sweating, kidney
disorders)
•
to treat you, if the volume of blood in your
blood vessels is low (hypovolaemia).
2. What you need to know before
you are given Sodium Chloride
0.45 & Glucose 5.0 Infusion
Do NOT receive Sodium Chloride 0.45 &
Glucose 5.0 Infusion if you are suffering
from any of the following con

Produktens egenskaper

Health Products Regulatory Authority
14 September 2018
CRN008HH1
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.45 % w/v and Glucose 5.0 % w/v Solution for Infusion
BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride: 4.5 g/l (0.45 % w/v)
Glucose (as monohydrate): 50.00 g/l (5.0 % w/v)
Each ml contains 50 mg glucose (as monohydrate) and 4.5 mg sodium
chloride.
mmol/l: Na+: 77 Cl-:77
mEq/l: Na+: 77 Cl-:77
Nutritional value: approximately 840 kJ/l (or 200 kcal/l)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles.
Osmolarity 432 mOsm/l (approx)
pH: 3.5 to 6.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sodium Chloride 0.45 % w/v and Glucose 5.0 % w/v solution is indicated
for:
- Treatment of dehydration or hypovolaemia in cases where supply of
water, sodium
chloride and carbohydrates is required due to restriction of the
intake of fluids and
electrolytes by normal routes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The choice of the specific sodium chloride and glucose concentration,
dosage,
volume, rate and duration of administration depends on the age,
weight, clinical
condition of the patient and concomitant therapy. It should be
determined by a
physician. For patients with electrolyte and glucose abnormalities and
for paediatric
patients, consult a physician experienced in intravenous fluid
therapy. Rapid
correction of hyponatraemia and hypernatraemia is potentially
dangerous (risk of
serious neurologic complications).
Health Products Regulatory Authority
14 September 2018
CRN008HH1
Page 2 of 14
_ADULTS, OLDER PATIENTS AND ADOLESCENTS (AGE 12 YEARS AND OVER):_
The recommended dosage is 500 ml to 3 L/24h
Administration rate
The infusion rate is usually 40 ml/kg/24h and should not exceed the
patient’s glucose
oxidation capacities in order to avoid hyperglycaemia. Therefore the
maximum acute
administration rate is 5 mg/kg/min.
_PAEDIATRIC POPULATION_
The dosage