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

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

GLUCOSE, SODIUM CHLORIDE

Dostupné z:

Baxter Healthcare Limited

ATC kód:

B05BB02

INN (Medzinárodný Name):

GLUCOSE, SODIUM CHLORIDE

Forma lieku:

SOLUTION FOR INFUSION

Zloženie:

GLUCOSE 5 percent weight/volume ; SODIUM CHLORIDE 0.45 percent weight/volume

Typ predpisu:

POM

Terapeutické oblasti:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2013-03-15

Príbalový leták

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

Súhrn charakteristických

Page 1 of 12
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).
_ADULTS, OLDER PATIENTS AND ADOLESCENTS (AGE 12 YEARS AND OVER): _
The recommended dosage is 500 ml to 3 L/24h
Administration rate
Page 2 of 12
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_ _varies with weight:

0-10 kg body weight:
100 ml/kg/24h

10-20 kg body weight:
1000 ml + (50 ml/kg over 10 kg)/24h