SUMMARY OF PRODUCT CHARACTERISTICS. Sodium Chloride 0.45 % w/v and Glucose 2.5% w/v Solution for Infusion BP

Transcription

1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Sodium Chloride 0.45 % w/v and Glucose 2.5% w/v Solution for Infusion BP 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Chloride: 4.5 g/l Glucose (as monohydrate): 25.0 g/l Each ml contains 25 mg glucose (as monohydrate) and 4.5 mg sodium chloride. mmol/l: Na+: 77 Cl-:77 meq/l: Na+: 77 Cl-:77 For a full list of excipients, see section PHARMACEUTICAL FORM Solution for infusion. Clear solution, free from visible particles. Osmolarity: 293 mosm/l (approx) ph: 3.5 to CLINICAL PARTICULARS 4.1 Therapeutic indications Sodium Chloride 0.45 % w/v and Glucose 2.5% 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 Posology The dosage and rate of administration depend on the age, weight, clinical, biological (acid-base balance) and metabolic conditions of the patient (and in particular the patient s hydration state) as

2 well as concomitant therapy. They should be determined by the consulting physician experienced in adult or paediatric intravenous fluid therapy. Adults and older people The recommended dosage is: 500 ml to 3 Litres/24h Administration rate: The infusion rate is usually 40 ml/kg/24h in adults and older people. The infusion rate 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 recommended dosage is: Adolescents: 500 ml to 3 Litres / 24h Infants, toddlers and children: kg body weight: 100 ml / kg / 24 h 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. The administration rate varies with age: 6-8 ml/kg/h for infants, 4-6 ml/kg/h for toddlers, and 2-4 ml/kg/h for children. The infusion rate is usually 40 ml/kg/24h in adolescents. The infusion rate should not exceed the patient s glucose oxidation capacities in order to avoid hyperglycaemia. Therefore the maximum acute administration rate is mg/kg/min for infants, toddlers and children, depending on the age and the total body mass. Note: Infants and toddlers: age ranges from 28 days to 23 months Children: age ranges from 2 to 11 years Adolescents: age ranges from 12 to 18 years Method of administration: The administration is performed by intravenous route. Precautions to be taken before manipulating or administering the product The solution for infusion should be visually inspected prior to use. Use only if the solution is clear, without visible particles and the container 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.

3 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. 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. Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration. Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers. Additives may be introduced before infusion or during infusion through the resealable medication port. When additive is used, verify isotonicity prior to parenteral administration. Thorough and careful aseptic mixing of any additive is mandatory. From a microbiological point of view, solutions containing additives should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, and would normally not be longer than 24 hours at 2 to 8 C, unless addition has taken place in controlled and validated aseptic conditions. For special precautions for disposal and other handling, please see also section 6.6. 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 contraindicated 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

4 The solution is also contraindicated in case of uncompensated diabetes, other known glucose intolerances (such as metabolic stress situations), hyperosmolar coma, hyperglycaemia, hyperlactataemia. 4.4 Special warnings and precautions for use General 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). Plasma electrolyte concentrations, fluid balance, glucose and acid-base balance should be closely monitored in all patients. This is especially true in paediatric patients as this population may have an impaired ability to regulate fluids and electrolytes. The infusion of hypotonic fluids together with the non-osmotic secretion of ADH 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 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 an 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 oxidation capacities, in order to avoid hyperglycaemia. Therefore the maximum administration rates provided in the posology section should not be exceeded (see section 4.2). 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. Sodium Chloride 0.45% w/v and Glucose 2.5% w/v solution contains glucose derived from corn. It should be used with caution in patients with known corn allergies (see section 4.8).

5 Long-term treatment During long-term treatment, an appropriate nutritive treatment must be given to the patient. In case of prolonged administration, take care avoiding hypokalaemia by monitoring plasma potassium levels and administering a potassium supplement as appropriate. Paediatric Population 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. Newborns especially those born premature and with low birth weight - are at increased risk of developing hypo- or hyperglycaemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycaemic control in order to avoid potential long term adverse effects. Hypoglycaemia in the newborn can cause prolonged seizures, coma and brain damage. Hyperglycaemia has been associated with intraventricular haemorrhage, late onset bacterial and fungal infection, retinopathy of prematurity, necrotizing enterocolitits, bronchopulmonary dysplasia, prolonged length of hospital stay, and death. In order to avoid potentially fatal over infusion of intravenous fluids to the neonate, special attention needs to be paid to the method of administration. When using a syringe pump to administer intravenous fluids or medicines to neonates, a bag of fluid should not be left connected to the syringe. When using an infusion pump all clamps on the intravenous administration set must be closed before removing the administration set from the pump, or switching the pump off. This is required regardless of whether the administration set has an anti free flow device. The intravenous infusion device and administration equipment must be frequently monitored. 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

6 There is no data reported on adverse reactions regarding the use of Sodium Chloride 0.45% w/v and Glucose 2.5% w/v during pregnancy or lactation. If used according to its intended purpose, Sodium Chloride 0.45% w/v and Glucose 2.5% 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 The following adverse reactions have been reported during administration of these solutions. The adverse reactions were coded with Preferred Terms (PT) sorted by System Organ Class (SOC) using Medical Dictionary for Regulatory Activities (MedDRA). Frequencies cannot be estimated from the available data, as the listed adverse reactions are based on spontaneous reporting, with the exception of hyponaetremia in paediatric population for which literature references on clinical trials exist. The adverse drug reactions listed in this section are given following the recommended frequency convention: very common ( 1/10); common ( 1/100 to < 1/10); uncommon ( 1/1000 to < 1/100); rare ( 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data). Tabulated list of adverse reactions associated with the products: System Organ Class Metabolism and nutrition disorders Adverse reactions (Preferred terms) Hyponatraemia Hypervolaemia Electrolyte imbalance Very common Not known Cardiac disorders Cardiac failure Not known Immune system disorders Anaphylactic reaction* Hypersensitivity* Not known Renal and urinary disorders Polyuria Not known Frequency Tabulated list of adverse reactions associated with technique of administration (i.e., intravenous route of administration): System Organ Class Adverse reactions (Preferred Terms) Frequency

7 Metabolism and nutrition disorders Vascular disorders General disorders and administration site conditions Hypervolaemia Vein injury Thrombophlebitis superficial Pyrexia* Chills* Infusion site infection Infusion site pain Infusion site reaction Infusion site phlebitis Not known Not known Not known Infusion site extravasation *Potential manifestation in patients with allergy to corn, see section 4.4 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation 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 directly (see details below). Ireland Pharmacovigilance Section Irish Medicines Board Kevin O Malley House Earlsfort Centre Earlsfort Terrace IRL - Dublin 2 Tel: Fax: Website: imbpharmacovigilance@imb.ie UK Yellow Card Scheme Tel: Freephone

8 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 solutions containing glucose 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. Sodium Chloride 0.45% w/v and Glucose 2.5% w/v is an isotonic solution of sodium chloride and glucose. The pharmacodynamic properties of Sodium Chloride 0.45% w/v and Glucose 2.5% w/v solution are those of its components (sodium, chloride and glucose). 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.

9 5.2 Pharmacokinetic properties The pharmacokinetic properties of this solution are those of its components (sodium, chloride and glucose). After injection of radiosodium ( 24 Na), 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 neurons; it is very slow in the bone. Sodium is predominantly excreted by the kidneys, but (as described earlier) there is extensive renal reabsorption. Small amounts of sodium are lost in the feces 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 6.2 Incompatibilities Incompatibility of the medicinal product to be added with the solution in Viaflo container must be assessed before addition. 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 2.5% w/v solution (see section 3). As a guidance, the following medications are incompatible with the Sodium Chloride 0.45 % w/v & Glucose 2.5% w/v solution (non-exhaustive listing): - Ampicillin sodium - Mitomycin

10 - 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 2.5% w/v solution should not be administered through the same infusion equipment as whole blood as haemolysis and clumping can occur. 6.3 Shelf life Unopened: and 500 ml bags: 24 months ml bags: 36 months In-use shelf life: Chemical and physical stability of any additive at the ph of the Sodium Chloride 0.45 % w/v & Glucose 2.5 % w/v solution in the Viaflo container should be established prior to use. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 C, unless reconstitution has taken place in controlled and validated aseptic conditions. 6.4 Special precautions for storage No special precautions for storage. 6.5 Nature and contents of container The bags known as Viaflo are composed of polyolefin/polyamide co-extruded plastic. The bags are overwrapped with a protective plastic pouch composed of polyamide/polypropylene. The bag size is either 250, 500 or 1000 ml. Outer carton contents: or or - 30 bags of 250 ml - 20 bags of 500 ml - 10 bags of 1000 ml. Not all pack sizes may be marketed.

11 6.6 Special precautions for disposal and other handling Discard after single use. Discard any unused portion. Do not reconnect partially used bags. For method of administration and precautions to be taken before handling or administering the medicinal product, please see also section Opening a. Remove the Viaflo 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 matters. If solution is not clear or contains foreign matters, discard the solution. 2. Preparation for administration Use sterile material for preparation and administration. a. Suspend container from eyelet support. b. Remove plastic protector from outlet port at bottom of container: - grip the small wing on the neck of the port with one hand, - grip the large wing on the cap with the other hand and twist, - the cap will pop off. 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 medication site. b. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. c. Mix solution and medication thoroughly. For high-density medication such as potassium chloride, tap the ports gently while ports are upright and mix. Caution: Do not store bags containing added medications. To add medicinal products during administration a. Close clamp on the set. b. Disinfect medication site.

12 c. Using syringe with 19 to 22-gauge needle, puncture resealable medication port and inject. d. Remove container from IV pole and/or turn to an upright position. 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 United Kingdom 8. MARKETING AUTHORISATION NUMBER(S) PL 00116/ DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 03/04/ DATE OF REVISION OF THE TEXT 07/2013