SODIUM CHLORIDE AND GLUCOSE

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

SODIUM CHLORIDE; GLUCOSE MONOHYDRATE

זמין מ:

Baxter Healthcare Limited

קוד ATC:

B05XA31

INN (שם בינלאומי):

SODIUM CHLORIDE; GLUCOSE MONOHYDRATE

כמות:

0.18/4 %w/v

טופס פרצבטיות:

Solution for Infusion

סוג מרשם:

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

איזור תרפויטי:

electrolytes in combination with other drugs

מצב אישור:

Marketed

תאריך אישור:

2007-08-24

עלון מידע

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 0.18% w/v &
Glucose 4% w/v Solution for Infusion BP, but will be
referred to as Sodium chloride 0.18 & Glucose 4 Infusion
throughout the remainder of this leaflet.
What is in this leaflet:
1.
What Sodium chloride 0.18 & Glucose 4 Infusion is
and what it is used for
2.
What you need to know before you are given
Sodium chloride 0.18 & Glucose 4 Infusion
3.
How you will be given Sodium chloride 0.18 &
Glucose 4 Infusion
4.
Possible side effects
5.
How to store Sodium chloride 0.18 & Glucose 4
Infusion
6.
Contents of the pack and other information
1. What Sodium chloride 0.18 &
Glucose 4 Infusion is and what it
is used for
Sodium chloride 0.18 & Glucose 4 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 0.18 & Glucose 4 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
0.18 & Glucose 4 Infusion
Do NOT receive Sodium chloride 0.18 &
Glucose 4 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)
•
when there is a larger volume

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
0.18%w/v Sodium Chloride and 4.0% w/v Glucose Intravenous Infusion BP,
(Viaflo Container)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium chloride:
1.80 g/l
Glucose (as monohydrate):
40.00 g/l
Each ml contains 1.8 mg sodium chloride and 40 mg glucose (as
monohydrate).
mmol/l (approx):
Na+: 30
Cl
-
: 30
approximately:
668 kJ/l (or 160 kcal)
For a full list of excipients, see section 6.1
.
3 PHARMACEUTICAL FORM
Solution for infusion
Sterile, non-pyrogenic, clear, colourless, aqueous Solution for
Infusion.
pH: 3.5-5.5 and osmolarity (approx): 284 m0sm/l
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sodium Chloride 0.18 % and Glucose 4% solution is used in the
following indications:
Dehydration treatment due to a moderated loss of sodium and chloride
(vomiting, diarrhoea, renal disorders, overuse of
diuretics) in cases where a source of energy is required (particularly
starvation).
Paediatric Population
This product should only be used in paediatric specialist settings
(such as renal, hepatic and cardiac units, high
dependency units and intensive care units) for intravenous fluid
therapy requiring the use of 0.18% sodium chloride and
4% glucose to maintain fluid and electrolyte balance.
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 gl