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 Holding B.V.

ATC-kod:

B05BB; B05BB02

INN (International namn):

Sodium chloride; Glucose

Dos:

0.45/5 percent weight/volume

Läkemedelsform:

Solution for infusion

Terapiområde:

Solutions affecting the electrolyte balance; electrolytes with carbohydrates

Bemyndigande status:

Marketed

Tillstånd datum:

2013-05-03

Bipacksedel

TH-30-01-903
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 condi

Produktens egenskaper

Health Products Regulatory Authority
24 September 2020
CRN008LNL
Page 1 of 11
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.
Fluid balance, serum glucose, serum sodium and other electrolytes
should be monitored before and during administration,
especially in patients with increased non-osmotic vasopressin release
(syndrome of inappropriate antidiuretic hormone
secretion, SIADH) and in patients co-medicated with vasopressin
agonist drugs due to the risk of hyponatraemia. Monitoring of
serum sodium is particularly important for physiologically hypotonic
fluids. Sodium Chloride 0.45 % w/v and Glucose 5.0 % w/v
solution may become extremely hypotonic after administration due to
glucose metab