Sodium Chloride 0.45% W/V And Glucose 5% W/V Iv Infusion Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Chloride 0.45% w/v and Glucose 5 % w/v Solution for Infusion BP.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Chloride: 4.5 g/l Glucose (as monohydrate): 50.00 g/l
Each ml contains 50 mg glucose (as monohydrate) and 4.5 mg sodium chloride mmol/l : Na+: 77 Cl-77 mEq/l: Na+: 77 Cl-77
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear solution, free from visible particles 432 mOsm/l (approx) pH: 3.5 to 6.5
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Sodium Chloride 0.45 % w/v and Glucose 5% w/v solution is used in the following indications: 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
Adults, the Elderly, Adolescents and Children
The dosage and rate of administration depend on the age, weight, clinical and biological (acid-base balance) conditions of the patient (in particular the patient’s hydration state) as well as concomitant therapy. They should be determined by the consulting physician.
Recommended dosage:
The recommended dosage is:
- for adults, the elderly and adolescents: 500 ml to 3 litres/24h
- for babies and children :
- 0-10 kg body weight: 100 ml /kg / 24 h
- 10-20 kg body weight: 1000 ml + (50 ml/ kg over 10 kg) / 24h
- > 20 kg body weight: 1500 ml + (20 ml/ kg over 20 kg) / 24h.
Administration rate:
The infusion rate is usually 40 ml/kg/24h in adults, the elderly and adolescents.
In pediatric patients the infusion rate is 5 ml/kg/h on average but the value varies with age: 6-8 ml/kg/h for infants, 4-6 ml/kg/h for toddlers, and 2-4 ml/kg/h for schoolchildren.
The infusion rate should not exceed the patient’s glucose oxidation capacities in order to avoid hyperglycaemia. Therefore the maximum acute administration rate ranges from 5mg/kg/min for adults to 10-18 mg/kg/min for babies and children, depending on the age and the total body mass.
Note:
- Infants and toddlers: age ranges from about 28 days to 23 months (a toddler is an infant who can walk)
- Children and schoolchildren: age ranges from about 2 years to 11 years Administration
The administration is performed by intravenous route.
Monitoring
Fluid balance and the concentrations of glucose and electrolytes (especially sodium) in plasma must be monitored during administration
4.3 Contraindications
The solution is contra-indicated in patients presenting:
- Extracellular hyperhydration or hypervolaemia
- Fluid and sodium retention
- Severe renal insufficiency (with oliguria/anuria)
- Uncompensated cardiac failure
- Hyponatraemia
- Hypochloraemia
General oedema and ascitic cirrhosis.
The solution is also contraindicated in case of uncompensated diabetes,
OTHER KNOWN GLUCOSE INTOLERANCES (SUCH AS METABOLIC STRESS SITUATIONS), HYPEROSMOLAR COMA, HYPERGLYCAEMIA, HYPERLACTATEMLA.
4.4 Special warnings and precautions for use
High volume infusion must be used under specific monitoring in patients with cardiac, pulmonary or renal failure.
Sodium salts should be administered with caution to patients with hypertension, heart failure, peripheral or pulmonary oedema, impaired renal function, pre-eclampsia, or other conditions associated with sodium retention (see also Section 4.5 - Interaction with other medicinal products and other forms of interaction).
Premature or term infants may retain an excess of sodium due to immature renal function. In premature or term infants, repeated infusions of sodium chloride should therefore only be given after determination of the serum sodium level.
Infusion of solutions containing glucose could be contraindicated in the first 24 hours following head trauma and blood glucose concentration should be closely monitored during intracranial hypertension episodes.
Administration of glucose containing solutions may lead to hyperglycaemia. In this case, it is recommended not to use this solution after acute ischemic stroke as hyperglycaemia has been implicated in increasing cerebral ischemic brain damage and impairing recovery.
When correcting hypovolaemia, care should be taken to not exceed the patient’s glucose oxdisation capacities, in order to avoid hyperglycaemia. Therefore the maximum administration rates provided in the posology section should not be exceeded (see section 4.2, “Posology”)
If hyperglycaemia occurs, rate of infusion should be adjusted or insulin administered, or if necessary, the treatment should be discontinued.
If administered to diabetics or patients with renal insufficiency, close monitoring of glucose levels is required, and insulin and/or potassium requirements may be modified.
During long-term treatment, a convenient nutritive treatment supply must be given to the patient.
In case of prolonged administration, take care to avoid hypokalaemia by monitoring plasma potassium levels and administering a potassium supplement as appropriate.
4.5 Interaction with other medicinal products and other forms of interaction
Interaction related to the presence of sodium:
Corticoids/Steroids and carbenoxolone which are associated with the retention of sodium and water (with oedema and hypertension).
Glucose should not be administered through the same infusion equipment as whole blood as haemolysis and clumping can occur.
4.6 Pregnancy and lactation
There is no data reported on adverse effects regarding the use of Sodium Chloride 0.45% w/v and Glucose 5% w/v during pregnancy or lactation. If used according to its intended purpose, Sodium Chloride 0.45% w/v and Glucose 5% w/v can be administered during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
During administration of this solution, the following undesirable effects have been reported as very common (>10%):
- Hyperhydration (associated or not with polyuria) and heart failure in patients with cardiac disorder or pulmonary oedema
- Asymptomatic electrolyte disturbances.
Hyponatraemia can uncommonly occur (> 0.1 %-<1%)
Adverse reactions may be associated with the technique of administration including febrile response, infection at the site of injection, local pain or reaction, vein irritation, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolaemia.
Adverse reactions may be associated to the medicinal product(s) added to the solution; the nature of the additive will determine the likelihood of any other undesirable effects.
In case of undesirable effect(s), the infusion must be discontinued.
4.9 Overdose
Retention of excess sodium when there is defective renal sodium excretion may result in pulmonary and peripheral oedema.
Hypernatraemia rarely occurs after therapeutic doses of sodium chloride. The most serious effect of hypernatraemia is dehydration of the brain which causes somnolence and confusion progressing to convulsions, coma, respiratory failure and death. Other symptoms include thirst, reduced salivation and lacrimation, fever, tachycardia, hypertension, headache, dizziness, restlessness, irritability and weakness.
Excessive administration of chloride salts may cause a loss of bicarbonate with an acidifying effect.
Prolonged administration or rapid infusion of large volumes of glucose containing solutions may lead to hyperosmolarity, dehydration, hyperglycaemia, hyperglucosuria and osmotic diuresis (due to hyperglycaemia).
In the event of accidental overdose, treatment should be discontinued and the patient should be observed for the appropriate signs and symptoms related to the solution and/or the added medicinal product administered.
5 PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Pharmacotherapeutic group: "Electrolytes with Carbohydrates" ATC code: B05BB02.
The pharmacodynamic properties of this solution are those of its components (glucose, sodium and chloride). Ions, such as sodium, circulate through the cell membrane, using various mechanisms of transport, among which is the sodium pump (Na-K-ATPase). Sodium plays an important role in neurotransmission and cardiac electrophysiology, and also in its renal metabolism. Chloride is mainly an extracellular anion. Intracellular chloride is in high concentration in red blood cells and gastric mucosa. Reabsorption of chloride follows reabsorption of sodium. Glucose is the principal source of energy in cellular metabolism.
5.2 Pharmacokinetic properties
The pharmacokinetic properties of this solution are those of its components (glucose, sodium, and chloride).
After injection of radiosodium (24Na), the half life is 11 to 13 days for 99% of the injected Na and one year for the remaining 1%. The distribution varies according to tissues: it is fast in muscles, liver, kidney, cartilage and skin; it is slow in erythrocytes and neurones; it is very slow in the bone. Sodium is predominantly excreted by the kidney, but (as described earlier) there is extensive renal reabsorption. Small amounts of sodium are lost in the faeces and sweat.
The two main metabolic pathways of glucose are gluconeogenesis (energy storage) and glycogenolysis (energy release). Glucose metabolism is regulated by insulin.
5.3 Preclinical safety data
Preclinical safety data of this solution for infusion in animals are not relevant since its constituents are physiological components of animal and human plasma.
Toxic effects are not to be expected under the condition of clinical application.
The safety of potential additives should be considered separately.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections
Hydrochloric acid (for pH adjustment)
6.2 Incompatibilities
In the absence of compatibility studies, this solution must not be mixed with other medicinal products.
The Instructions for Use of the medicinal product to be added must be consulted. Before adding a drug, verify it is soluble and stable in water at the pH of Sodium Chloride 0.45% w/v and Glucose 5% w/v solution (pH: 3.5-6.5). As a guidance, the following medications are incompatible with the Sodium Chloride 0.45 % w/v & Glucose 5% w/v solution (non-exhaustive listing):
■ Ampicillin sodium
■ Mitomycin
■ Amphotericin B
■ Erythromycin lactobionate
Those additives known to be incompatible should not be used.
Because of the presence of glucose, “Sodium chloride 0.45% w/v and Glucose 5% w/v solution” should not be administered through the same infusion equipment as whole blood as hemolysis and clumping can occur.
6.3 Shelf life
The shelf life is 15 months providing the unit has not been opened.
In-use shelf-life: From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
6.4 Special precautions for storage
Storage temperature should not exceed 25°C. Viaflex containers should be stored within their overpouch.
6.5 Nature and contents of container
The solution is supplied in a plastic Viaflex infusion bag fabricated from PVC. The bag contains either 500 ml or 1000 ml and is sealed in a protective plastic overpouch.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Handling and Preparation
Use only if the solution is clear, without visible particles and if the container is undamaged.
Administer immediately following the insertion of infusion set.
Do not remove unit from overwrap until ready for use.
The inner bag maintains the sterility of the product.
Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.
The solution should be administered with sterile equipment using an aseptic technique. The equipment should be primed with the solution in order to prevent air entering the system.
Additives may be introduced before infusion or during infusion through the injection port. When additive is used, verify isotonicity prior to parenteral administration. Thorough and careful aseptic mixing of any additive is mandatory. Solutions containing additives should be used immediately and not stored.
Adding other medications or using incorrect administration technique might cause the appearance of fever reactions due to the possible introduction of pyrogens. In case of an adverse reaction, infusion must be stopped immediately.
Discard after single use.
Discard any unused portion.
Do not reconnect partially used bags.
1 _Opening
a. Remove the Viaflex container from the overpouch just before use.
b. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution, as sterility may be impaired.
c. Check the solution for limpidity and absence of foreign matter. If solution is not clear or contains foreign matter, discard the solution.
2 _Preparation for administration
Use sterile material for preparation and administration.
a. Suspend container from base eyelet support.
b. Remove blue protector from outlet port.
c. Use an aseptic method to set up the infusion.
d. Attach administration set. Refer to complete directions accompanying set for connection priming of the set and administration of the solution.
3._Techniques for injection of additive medications
Warning: Additives may be incompatible.
To add medication before administration
a. Disinfect the medication port.
b. Using a syringe with a 20 gauge(0.9mm) to22 gauge (0.70mm) needle, puncture the resealable medication port and inject.
c. Mix the solution and medication thoroughly. For high density medications such as potassium chloride, tap the ports gently while ports are upright and mix.
To add medication during administration
a. Close clamp on the set.
b. Disinfect medication port.
c. Using syringe with 20 gauge(0.9mm) to 22gauge (0.70mm) needle, puncture re-sealable medication port and inject.
Remove container from IV pole and/or turn to an upright position.
d.
e. Evacuate both ports by tapping gently while the container is in an upright position.
f. Mix solution and medication thoroughly.
g. Return container to in use position, re-open the clamp and continue administration.
7 MARKETING AUTHORISATION HOLDER
Baxter Healthcare Ltd.,
Caxton Way,
Thetford,
Norfolk,
IP24 3SE
8 MARKETING AUTHORISATION NUMBER(S)
PL 00116/0016R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 15/08/2001
10 DATE OF REVISION OF THE TEXT
18/01/2012