Sodium Chloride 0.9 % w/v and Glucose 5% w/v Solution for Infusion BP (Viaflo container)

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Sodium chloride; Sodium chloride; Glucose monohydrate; Glucose monohydrate

Dostopno od:

Baxter Healthcare Limited

Koda artikla:

B05CB; B05CB01

INN (mednarodno ime):

Sodium chloride; Sodium chloride; Glucose monohydrate; Glucose monohydrate

Odmerek:

0.9/5 %w/v percent weight/volume

Farmacevtska oblika:

Solution for infusion

Tip zastaranja:

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

Terapevtsko območje:

Salt solutions; sodium chloride

Status dovoljenje:

Not marketed

Datum dovoljenje:

2004-04-27

Navodilo za uporabo

TH-30-01-806
1. What Sodium Chloride 0.9
& Glucose 5 Infusion is and
what it is used for
Sodium Chloride 0.9 & Glucose 5 Infusion is a
solution of the following substances in water:
•
sugar (glucose)
•
sodium chloride.
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 0.9 & Glucose 5 Infusion is
used:
•
as a source of carbohydrate (sugar).
•
to treat a loss of sodium from the blood and
the body (sodium depletion)
•
to treat a loss of body water, for example
after being sick or having diarrhoea
(extracellular dehydration)
•
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 0.9 & Glucose 5
Infusion
Do NOT receive Sodium Chloride 0.9 &
Glucose 5 Infusion if you are suffering
from any of the following conditions
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 0.9%
w/v & Glucose 5% w/v Solution for Infusion BP’,
but will be referred to as ‘Sodium Chloride 0.9
& Glucose 5 Infusion’ throughout the remainder
of this leaflet.
What is in this leaflet:
1.
What Sodium Chloride 0.9 & Glucose 5
Infusion is and what it is used for
2.
What you need to know before you are
given Sodium Chloride 0.9 & Glucose 5
Infusion
3.
How you will be given Sodium Chloride
0.9 & Glucose 5 Infusion
4.
Possible side effects
5.
How to store Sodium Chloride 0.9 &
Glucose 5 Infusion
6.
Contents of the pack and other
information
1
Package Leaflet: Information for the user
Sodium Chloride 0.9% w/v & Glucose 5% w/v
Solution for

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.9 % w/v and Glucose 5% w/v Solution for Infusion BP
(Viaflo container)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride:
9.0 g/l (0.9% w/v)
Glucose (as monohydrate):
50.0 g/l (5.0% w/v)
Each ml contains 50 mg glucose (as monohydrate) and 9.0 mg sodium
chloride.
mmol/l:
Na
+
:
154
Cl
-
:154
mEq/l:
Na
+
:
154
Cl
-
:154
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: 585 mOsm/l (approx)
pH: 3.5 to 6.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sodium Chloride 0.9 % w/v and Glucose 5% w/v solution is indicated
for:
-
Treatment of sodium depletion, extracellular dehydration or
hypovolaemia in cases where supply of water 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:
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