Sodium Chloride 0.3 % w/v and Glucose 3.3% w/v Solution for Infusion BP

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Sodium chloride; Glucose

Saadav alates:

Baxter Holding B.V.

ATC kood:

B05CB; B05CB01

INN (Rahvusvaheline Nimetus):

Sodium chloride; Glucose

Annus:

0.3/ 3.3 percent weight/volume

Ravimvorm:

Solution for infusion

Terapeutiline ala:

Salt solutions; sodium chloride

Volitamisolek:

Marketed

Loa andmise kuupäev:

2004-06-18

Infovoldik

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SODIUM CHLORIDE 0.3% W/V & GLUCOSE 3.3% 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 0.3% w/v & Glucose 3.3% w/v
Solution for Infusion BP’, but will
be referred to as ‘Sodium Chloride 0.3 & Glucose 3.3 Infusion’
throughout the remainder of this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Sodium Chloride 0.3 & Glucose 3.3 Infusion is and what it is used
for
2.
What you need to know before you are given Sodium Chloride 0.3 &
Glucose 3.3 Infusion
3.
How you will be given Sodium Chloride 0.3 & Glucose 3.3 Infusion
4.
Possible side effects
5.
How to store Sodium Chloride 0.3 & Glucose 3.3 Infusion
6.
Contents of the pack and other information
1.
WHAT SODIUM CHLORIDE 0.3 & GLUCOSE 3.3 INFUSION IS AND WHAT IT IS USED
FOR
Sodium Chloride 0.3 & Glucose 3.3 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 132 kilocalories per litre.
Sodium and chloride are chemical substances found in the blood.
Sodium Chloride 0.3 & Glucose 3.3 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 0.3 &
GLUCOSE 3.3 INFUSION
DO NOT RECEIVE SODIUM CHLORIDE 0.3 & GLUCOSE 3.3 INFUSION IF YOU ARE
SUFFERING FROM ANY OF THE
FOLLOWING CONDITIONS

when you

Toote omadused

Health Products Regulatory Authority
24 September 2020
CRN008LNL
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.3 % w/v and Glucose 3.3% w/v Solution for Infusion
BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride: 3.0 g/l (0.3% w/v)
Glucose (as monohydrate): 33.0 g/l (3.3% w/v)
Each ml contains 33 mg glucose (as monohydrate) and 3 mg sodium
chloride.
mmol/l: Na+: 51 Cl-:51
mEq/l: Na+: 51 Cl-:51
Nutritional value: approximately 544 kJ/l (or 132 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: 285 mOsm/l (approx) pH: 3.5 to 6.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sodium Chloride 0.3% w/v and Glucose 3.3% 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 0.3% w/v and Glucose 3.3% w/v solution may become
extremely hypotonic after administration due to
glucose metabolisation in