Freeflex
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.18% and Glucose 4% Infusion BP Polyfusor as Steriflex No. 18 or freeflex
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Steriflex No. 18 has the following composition:
|
Name |
Specification Reference |
%w/v |
|
Potassium Chloride |
EP |
0.18 |
|
Glucose Monohydrate for Parenteral Use |
EP |
4.4 |
|
(Equivalent to Anhydrous Glucose |
4.0) |
3. PHARMACEUTICAL FORM
Intravenous fluid
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
An isotonic solution for maintenance treatment of dehydration with carbohydrate loss.
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
For intravenous infusion.
The volume and rate of infusion will depend upon the requirements of the individual patient and the judgement of the physician.
Elderly
A reduced volume and rate of infusion may be necessary to avoid circulatory overload, particularly in patients with cardiac and renal insufficiency.
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.
4.3 Contraindications
Patients with impaired renal or cardiac function. The intravenous infusion of glucose containing solutions may be hazardous in patients with impaired liver function.
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.
4.4 Special warnings and precautions for use
Glucose-Saline Solutions should not be administered rapidly or for prolonged periods
particularly in infants and the elderly. In potassium deficient patients administration of saline will increase potassium loss, so that if it is given, potassium supplements should also be given.
Restrict intake in impaired renal function, cardiac failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy. This guidance is particularly relevant for isotonic and hypertonic forms.
The label states:
Do not use unless solution is free from particles.
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.
4.5. Interactions with other Medicinal Products and other Forms of Interaction
No clinically significant drug interactions known.
4.6. Pregnancy and Lactation
The safety of steriflex No.18 during pregnancy and lactation has not been assessed, but its use during these periods is not considered to constitute a hazard.
4.7. Effects on Ability to Drive and Use Machines
Not applicable.
4.8 Undesirable effects
Thrombosis of the chosen vein is always a possibility with intravenous infusion. If Infusion is protracted then another vein should be selected after 12 to 24 hours.
Post Marketing Adverse reactions: Metabolism and nutrition disorders - severe hyponatraemia, which could lead to death, has been reported.
4.9 Overdose
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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Sodium chloride provides essential sodium and chloride ions to maintain the osmotic tension of the extracellular fluid and tissues.
Glucose is a monosaccharide which provides a source of energy.
5.2. Pharmacokinetic Properties
Glucose is metabolised via pyruvic or lactic acid to carbon dioxide and water with the release of energy. All body cells are capable of oxidising glucose and it forms the principal source of energy in cellular metabolism.
5.3. Pre-clinical Safety Data
6. PHARMACEUTICAL PARTICULARS 6.1. List of Excipients
|
Name |
Specification Reference |
%w/v |
|
Water for Injections in bulk |
EP |
TO 100 |
|
Hydrochloric Acid |
EP |
QS |
|
Sodium Hydroxide |
BP |
QS |
Incompatibilities
6.2.
Because of the nature of the plastic material of the Steriflex bag (PVC), this solution should not be used as a vehicle for the administration of drugs which may be sorbed to the surface of the bag to varying and significant degrees.
6.3. Shelf-Life
24 months.
6.4. Special Precautions for Storage
Store at 2° to 25°C.
6.5. Nature and Contents of Container
The container is a flexible bag made of medical grade PVC.
a) A hermetically sealed polythene bag.
b) A rectangular pouch consisting of polyamide/polythene composite
c) Polyamide/Polyethylene-Propylene composite laminate welded to polypropylene ethylene propylene composite, plugged with a polycarbonate plug with either a bromobutyl (West 4481/45) or gum (West 7006/45) stopper.
Or
A flexible polyolefine bag sealed in a polyolefine overwrap.
6.6. Instruction for Use, Handling and Disposal
Opening the overwrap:
Locate the corner tabs at the end of the bag. Grip the two tabs and pull the two halves of the overwrap apart, releasing the bag onto a clean surface.
Setting up the solution:
Position the roller clamp of the giving-set to just below the drip chamber and close. Hold the base of the giving set port firmly and grip the wings of the twist of tab. Twist to remove the protective cover.
Still holding the base of the giving-set port push the set spike fully into the port to ensure a leak proof connection.
Prime the set in accordance with the manufacturer’s instructions.
7 MARKETING AUTHORISATION HOLDER
Fresenius Kabi Limited Cestrian Court Eastgate Way Manor Park Runcorn Cheshire WA7 1NT UK
8. MARKETING AUTHORIZATION NUMBER
PL 08828/0069
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/02/2009