Sodium Chloride 0.45 % w/v and Glucose 2.5% w/v Solution for Infusion BP

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Sodium chloride; Sodium chloride; Glucose monohydrate; Glucose monohydrate

थमां उपलब्ध:

Baxter Healthcare Limited

ए.टी.सी कोड:

B05CB; B05CB01

INN (इंटरनेशनल नाम):

Sodium chloride; Sodium chloride; Glucose monohydrate; Glucose monohydrate

डोज़:

0.45 2.5 percent weight/volume

फार्मास्यूटिकल फॉर्म:

Solution for infusion

प्रिस्क्रिप्शन प्रकार:

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

चिकित्सीय क्षेत्र:

Salt solutions; sodium chloride

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2004-11-12

सूचना पत्रक

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 & Glucose 2.5% w/v Solution for Infusion BP’,
but will be referred to as ‘Sodium Chloride 0.45 &
Glucose 2.5 Infusion’ throughout the remainder of
this leaflet.
What is in this leaflet:
1.
What Sodium Chloride 0.45 & Glucose 2.5
Infusion is and what it is used for
2.
What you need to know before you are
given Sodium Chloride 0.45 & Glucose 2.5
Infusion
3.
How you will be given Sodium Chloride 0.45
& Glucose 2.5 Infusion
4.
Possible side effects
5.
How to store Sodium Chloride 0.45 &
Glucose 2.5 Infusion
6.
Contents of the pack and other information
1. What Sodium Chloride 0.45
& Glucose 2.5 Infusion is and
what it is used for
Sodium Chloride 0.45 & Glucose 2.5 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 100 kilocalories
per litre.
Sodium and chloride are chemical substances
found in the blood.
Sodium Chloride 0.45 & Glucose 2.5 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 2.5 Infusion
Do NOT receive Sodium Chloride 0.45 &
Glucose 2.5 Infusion if you are suffering
from any of the following conditions
•
when you know you are allergic to the product
•
when there is too much fluid in the spaces
around the cells of the body (extracellular
hyperhydration

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.45 % w/v and Glucose 2.5% w/v Solution for Infusion
BP.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride:
4.5 g/l (0.45 % w/v)
Glucose (as monohydrate):
25.0 g/l (2.5 % w/v)
Each ml contains 25 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 420 kJ/l (or 100 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 293 mOsm/l (approx)
pH: 3.5 to 6.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sodium Chloride 0.45 % w/v and Glucose 2.5% 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
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
-
> 20 kg body weight:
1500 ml + (20 ml