MACO PHARMA SODIUM CHLORIDE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SODIUM CHLORIDE ; GLUCOSE MONOHYDRATE

Available from:

Maco Pharma (UK) Ltd

ATC code:

B05BB02

INN (International Name):

SODIUM CHLORIDE ; GLUCOSE MONOHYDRATE

Dosage:

%w/v

Pharmaceutical form:

Solution for Infusion

Prescription type:

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

Therapeutic area:

electrolytes with carbohydrates

Authorization status:

Marketed

Authorization date:

2001-12-03

Patient Information leaflet

WHAT IS IN THIS LEAFLET
1. What Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion
is and what it is used for
2. What you need to know before you are given Sodium Chloride 0.18%w/v
Glucose 4%w/v Solution for Infusion
3. How Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion is
given
4. Possible side effects
5. How to store Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for
Infusion
6. Contents of the pack and other information
1. WHAT SODIUM CHLORIDE 0.18%W/V GLUCOSE
4%W/V SOLUTION FOR INFUSION IS AND WHAT IT IS
USED FOR
Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for
Infusion is a clear, colourless to faintly straw-coloured
solution of sodium chloride and glucose in water.
The solution is stored in a sealed flexible plastic bag.
Glucose sodium chloride solution is given to replace fluid loss
from the body. Glucose is a simple sugar, which provides a
source of energy. Sodium chloride (salt) helps to maintain the
correct balance of fluid in and around the body’s cells and
tissues.
Glucose sodium chloride solution may be given alone but may
be given with other medicines added.
You will be given glucose sodium chloride solution in hospital
by a doctor or nurse.
The solution should be used in children only in specialist
paediatric units under expert medical supervision, to maintain
the correct balance of fluids and salts.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN SODIUM CHLORIDE 0.18%W/V GLUCOSE 4%W/V
SOLUTION FOR INFUSION
YOU MUST NOT BE GIVEN this solution if you have:
• an ALLERGY to sodium chloride, glucose or any of the other
ingredients
• if you are having regular treatment for abnormal fluid levels
• after ischaemic stroke
• within 24 hours of head injury, or
• if you have abnormal levels of hydration with low sodium
salt levels.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse if you:
• have HEART FAILURE, KIDNEY PROBLEMS, HIGH BLOOD PRESSURE,
LIVER DISEASE, or OEDEMA (swelling)
• have DIABETES MELLITUS
• have PRE-ECLAMPSIA of pregnancy
• are receiving SAL

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.18% w/v Glucose 4%w/v Solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
0.18% w/v sodium chloride and 4% w/v anhydrous glucose (as glucose
monohydrate).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Infusion
Sterile non-pyrogenic infusion solution, colourless to faintly
straw-coloured without visible particles.
pH 3.5 - 6.5
Osmolality: 290mOsm/kg H
2
O (approx).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in prophylactic and replacement therapy requiring the use of
glucose and sodium chloride.
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
_Posology_
The volume of glucose sodium chloride solution needed to replenish
fluid deficits varies with age, body weight,
complementary treatment and severity of the clinical condition. The
dose and rate of administration are typically betwee
500ml and 3000ml per 24 hours but are subject to clinical and
laboratory assessment in each case.
Paediatric Population
Use of 0.18% sodium chloride and 4% glucose should be restricted to
specialist
paediatric settings such as renal,
hepatic and cardiac units, high dependency units and intensive care
units.
The dosage depends
on the age,
weight,
clinical
and biological
(acid-base balance)
conditions
of
the patient,
concomitant therapy and should be determined by the consulting
specialist.
Monitoring:
Adequate urine flow must
be ensured and careful
monitoring of
fluid balance,
plasma and urinary
electrolyte concentrations are essential.
Active component
Per 500ml
Per 1000ml
Sodium chloride
0.9g
Na+ 15 mmol
C1- 15 mmol
1.8g
Na+ 30 mmol
C1-
30 mmol
Glucose monohydrate
22.0g equivalent to
20.0