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

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Sodium chloride; Glucose monohydrate

Tillgänglig från:

Baxter Healthcare Limited

ATC-kod:

B05CB; B05CB01

INN (International namn):

Sodium chloride; Glucose monohydrate

Dos:

0.3 3.3 percent weight/volume

Läkemedelsform:

Solution for infusion

Receptbelagda typ:

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

Terapiområde:

Salt solutions; sodium chloride

Bemyndigande status:

Not marketed

Tillstånd datum:

2004-06-18

Bipacksedel

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 know you are a

Produktens egenskaper

Health Products Regulatory Authority
14 September 2018
CRN008HG3
Page 1 of 14
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_._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
Health Products Regulatory Authority
14 September 2018
CRN008HG3
Page 2 of 14
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 dosagevaries w