MACO PHARMA SODIUM CHLORIDE

Sodium Chloride 0.18% w/v Glucose 4%w/v Solution for infusion

0.18% w/v sodium chloride and 4% w/v anhydrous glucose (as glucose monohydrate).

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 20.0g anhydrous 111 mmol	44.0g equivalent to 40.0g anhydrous 222 mmol

For a full list of excipients, see section 6.1.

Solution for Infusion

Sterile non-pyrogenic infusion solution, colourless to faintly straw-coloured without visible particles.

pH 3.5 - 6.5

Osmolality: 290mOsm/kg H₂O (approx).

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.

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 between 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.

Method of administration

For intravenous infusion under medical supervision.

Single use only.

Administer with caution to patients with conditions of impaired sodium control such as congestive heart failure, severe renal insufficiency, cardio-pulmonary disease, cirrhosis of the liver, or to patients receiving salt steroids.

The solution must not be used in cases of:

⎯ routine rehydration or fluid maintenance therapy

⎯ hyperhydration states

⎯ dehydration with hyponatraemia

⎯ acute ischaemic stroke

⎯ head trauma (first 24 hours)

Paediatric Population

This product should not be used in children except in paediatric specialist settings (such as renal, hepatic and cardiac units, high dependency units and intensive care units) under expert medical supervision.

The solution must be administered with caution to diabetics, patients with peripheral or pulmonary oedema, hypertension, pre-eclampsia.

The pathophysiological response to dehydration, to electrolyte loss and to glucose sodium chloride infusion will vary with the age of the patient being treated and this should be taken into account during rehydration therapy. Fluid replacement therapy should be administered with caution to very young and elderly patients.

Prior to and during infusion, serum and/or urinary electrolytes and glucose should be monitored to assess the nature and severity of fluid depletion and electrolyte imbalance. Close monitoring of patients with diabetes mellitus, and in patients with renal failure, is necessary during glucose infusion.

Paediatric Population
Intravenous fluid therapy should be closely monitored in the paediatric population as they may have impaired ability to regulate fluids and electrolytes. Adequate urine flow must be ensured and careful monitoring of fluid balance, plasma and urinary electrolyte concentrations are essential.
The infusion of hypotonic fluids together with the non-osmotic secretion of ADH (in pain, anxiety, the post-operative state, nausea, vomiting, pyrexia, sepsis, reduced circulating volume, respiratory disorders, CNS infections, and metabolic and endocrine disorders) may result in hyponatraemia. Hyponatraemia can lead to headache, nausea, seizures, lethargy, coma, cerebral oedema and death, therefore acute symptomatic hyponatraemic encephalopathy is considered a medical emergency.

Glucose infusions are incompatible with blood for transfusion as haemolysis or clumping can occur; do not administer through the same infusion equipment as blood or blood components for transfusion (either before, during or after their administration).
Do not use unless solution is clear and the container undamaged. Thorough and careful aseptic mixing of any additives is mandatory (see section 6.6, Special precautions for disposal and other handling).

Check compatibility of medicinal products with glucose sodium chloride solution before administration with the solution. The slightly acidic pH of the solution should be taken into account. See section 6.2 Incompatibilities.

It is important to avoid maternal hyperglycaemia during intravenous glucose infusion in the perinatal period in view of the possibility of inducing neonatal hypoglycaemia.

Not relevant.

Blood and lymphatic system disorders.
Not known: Infusion of glucose sodium chloride solution may lead to fluid and electrolyte imbalances such as hypokalaemia, hypomagnesaemia and hypophosphataemia. Hypokalaemia may complicate glucose infusions, especially when combined with insulin in the treatment of diabetic ketoacidosis. Other adverse effects may be sodium retention, oedema.
Cardiac disorders: Not known: Hypertension, tachycardia.
Gastrointestinal disorders: Not known: Gastrointestinal effects.
General disorders and administration site conditions: Not known: Prolonged intravenous infusion may lead to venous irritation and thrombophlebitis at the infusion site.

Post Marketing Adverse reactions: Metabolism and nutrition disorders – severe hyponatraemia, which could lead to death, has been reported.

In the event of adverse reaction, stop infusion immediately.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:

For United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

For Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

E-mail: medsafety@hpra.ie

Overdosage may lead to fluid overload, electrolyte imbalance and possibly hyperglycaemia. Hyperglycaemia may need to be treated with insulin and fluid overload with a diuretic. Electrolyte disturbances may need to be treated with either sodium-free or sodium containing intravenous fluids.
In paediatric patients, hyponatraemia may be a consequence of overdose and needs urgent specialist treatment.

Pharmacotherapeutic group: Solutions affecting the electrolyte balance -electrolytes with carbohydrates, ATC code: B05BB02

Sodium Chloride 0.18%w/v Glucose 4%w/v Solution for Infusion is a sterile non-pyrogenic solution. Glucose is a physiological carbohydrate, a simple and easily assimilatable source of energy. In parenteral nutrition glucose allows intracellular rehydration and also serves as an alternative energy source to protein and lipid catabolism. Sodium and chloride contribute to acid-base balance. Sodium is the principal cation in extracellular fluid and is the main osmotic component in control of blood volume.

Glucose can be utilized immediately, metabolized by glycolysis or the pentose phosphate pathway into carbon dioxide and water, with the release of energy, or stored in liver and muscle. Normal blood concentration is approximately 0.80g/l.Glucose is normally filtered by the glomerules but total reabsorption by the proximal tubule occurs at concentrations below 1.8g/l. The maximum rate of glucose utilization is estimated to be about 500 – 800mg per kg body-weight per hour.

Sodium is principally distributed into extracellular fluid (44%), skeleton (47%) and intracellular fluid (8%). Half life is 11 – 13 days. Excretion is predominantly by renal filtration and reabsorption by the proximal tubule, with a small quantity excreted by faeces, sweat and saliva. The pharmacokinetics of chloride are linked to those of sodium.

Water for Injections

2 years.

After opening overwrap: Use immediately on removal from overwrap.

Do not store above 25°C. Do not freeze. Store in the original package to prevent moisture loss.

Macoflex flexible PVC bags containing 500ml or 1000ml solution, with an infusion site and polycarbonate-latex injection site for addition of medicinal products. Bags are individually overwrapped in transparent polypropylene laminate.

Not all pack sizes may be marketed

Maco Pharma (UK) Ltd.,

8^th Floor- Regal House

70 London Road

Twickenham

Middlesex TW1 3QS

United Kingdom

PA 931/4/1

Date of first authorisation: 03 December 2001

Date of last renewal: 19 August 2010

January 2016

Do not use unless the solution is clear and the container undamaged.

Discard any unused solution. Do not reconnect partially used bags.

The space between the bag and the overwrap is not guaranteed sterile.

Any unused product should be disposed of in accordance with local requirements.

Remove the bag from the plastic overwrapping. Remove the twist-off protector of the infusion site and connect by clamping to the administration set.

Addition of medicinal products: Confirm additive compatibility before addition through the injection port. Clean the injection site using antiseptic solution. Carefully introduce the sterile needle into the sterile chamber in the latex injection site, attach the needle to the container with the medicinal product, introduce the needle through the second latex membrane into the bag and inject the medicine. Carefully withdraw the needle. Mix thoroughly with the solution. Use immediately.