Your doctor will advise you If In the absence of compatibility studies, this solution must not be mixed with other medicinal products. Sodium chloride 20 mM – Cadmium chloride 1 mM – Sodium cacodylate Buffer pH 6.5; 50 mM – 2-Methyl-2,4-pentanediol 35% solution 1 Product Result Composition, osmolarity, and ionic concentration are shown below: 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an … Do not add medication before hanger and ports have been straightened and the container inspected. If an administration set with a combined air inlet/fluid path connector has to be used, ensure the air inlet tube is always clamped off. The frequency of the adverse drug reactions listed in this section cannot be estimated from the available data. between patient and physician/doctor and the medical advice they may provide. with your doctor. Techniques for injection of additive medications. d. Prime set and regulate administration as required. In general, the risk of dilutional states (retention of water relative to sodium) is inversely proportional to the electrolyte concentrations of Sodium Chloride 0.9% and its additions. Warning: Additives may be incompatible. When used in conjunction with cell separator procedures, the solution is contraindicated in those patients where adequate anticoagulation cannot be achieved. c. Squeeze container and inspect for minute leaks and examine solution for visible particles or cloudiness by viewing along seam. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. Close clamp on the set. Do not store or reconnect partly used containers. It allows continued monitoring of the benefit/risk balance of the medicinal product. Like other medicines, sodium chloride can cause some side effects. 8. In case of adverse reaction, infusion must be stopped immediately. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary. Conversely, the risk of solute overload causing congested states (retention of solute relative to water) is directly proportional to the electrolyte concentrations of Sodium Chloride 0.9% and its additions. Administer immediately following the insertion of infusion set. The inner bag maintains the sterility of the product. Geriatric patients are at increased risk of developing electrolyte imbalances. For powder drug vials position the drug vial below the Minibag Plus and squeeze the Minibag Plus to transfer solution thereby partially filling the vial approximately 1/2 full. General adverse effects of sodium excess in the body include nausea, vomiting, diarrhea, abdominal cramps, thirst, reduced salivation and lacrimation, sweating, fever, tachycardia, hypertension, renal failure, peripheral and pulmonary oedema, respiratory arrest, headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma, and death. 5. If use cannot be avoided, monitor serum sodium concentrations. Hyponatraemia may occur when normal free water excretion is impaired. b. Remove the protective overpouch by tearing down from notch and remove container. d. Discard unit if leaks, particles or cloudiness are evident. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. The below listed drugs increase the vasopressin effect, leading to reduced renal electrolyte free water excretion and may increase the risk of hospital acquired hyponatraemia following inappropriately balanced treatment with i.v. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. News-Medical.Net provides this medical information service in accordance Tell your doctor or nurse as soon as possible if you do not feel well while you are Attach administration set. Last updated on Aug 1, 2020. 11. Solutions containing additives should be used immediately and not stored. Avoid excessive heat. Other Products that Affect Fluid and/or Electrolyte Balance If an adverse event occurs the patient should be evaluated and appropriate counter measures be started, if needed the infusion should be stopped. 4.4, 4.5). The solution is for administration by intravenous infusion through a sterile and non-pyrogenic administration set, using aseptic technique. Do not administer unless solution is clear, and container is undamaged. is found on the packaging: Ampoules: AUST R 49272, AUST R 49278 and AUST R 49279. It contains no antimicrobial agents. The medical literature, the additive package insert and other available sources of information should be reviewed for a more thorough understanding of possible incompatibility problems. It does not take the place of talking to your doctor or pharmacist. When used in conjunction with cell separator procedures, there is a risk of air embolism or haemolysis. See WARNINGS and ADVERSE REACTIONS. The Minibag Plus Container is a standard diluent container with an integral closed system transfer device (CSTD) drug vial adaptor. Excessive administration of Sodium Chloride Injection, USP can cause fluid overload (which can lead to pulmonary and/or peripheral edema). Preparation for Administration Hold the reconstitution device with your thumb and index finger and push the device over the drug vial, puncturing the stopper and locking in place. However, if you are given too much sodium chloride you may experience some of the Additives may be introduced before infusion or during infusion through the re-sealable medication port. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. If use cannot be avoided, monitor serum electrolytes, fluid balance and acid-base balance. Symptoms of unknown aetiology which can appear to be hypersensitivity reactions have been reported very rarely in association with infusion of Sodium Chloride 0.9 %. Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. Date of first authorisation/renewal of the authorisation. Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. 7. Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Plasma electrolyte concentrations should be closely monitored in the paediatric population as this population may have impaired ability to regulate fluids and electrolytes. 3. Appropriate therapeutic countermeasures must be instituted as clinically indicated. This medicine is available only with a doctor's prescription. 5. There are no adequate and well controlled studies with Sodium Chloride Injection, USP in pregnant women and animal reproduction studies have not been conducted with this drug. doctor the risks and benefits being given Sodium Chloride Injection or Intravenous 4. Ask your doctor c. Using a syringe with a 20 – 22 gauge needle, puncture re-sealable medication port and inject. Mix solution and medication thoroughly. This leaflet answers some common questions about Sodium Chloride Injection and Sodium The following adverse reactions have been reported in post-marketing experience. If administration set becomes blocked do not pump contents back into container but replace equipment. g. Return container to in use position, re-open the clamp and continue administration. The introduction of additives to any solution, regardless of type of container, requires special attention to assure that no incompatibilities result. Repeated infusions of sodium chloride should therefore only be given after determination of the serum sodium level. Remove the protector from the administration port as follows: a. with one hand, grip the wings of the blue protector below the fracture zone (a), b. with the other hand, grip the wings above the fracture zone (b), c. remove the upper section of the protector with one twisting movement (c), d. insert the set connector well into the port (d). For Information on Risk of Air Embolism – see DOSAGE AND ADMINISTRATION. Rapidly correcting hypernatraemia once adaptation has occurred may lead to cerebral oedema, potentially resulting in seizures, permanent brain damage, or death. It may also be used as a vehicle for the reconstitution and administration of intravenous medications. To open, tear overwrap down side at slit and remove solution container. Details of the use of the set can be recorded – record labels are available from Baxter Healthcare Ltd. Chemical and physical stability of any additive medication at the pH of the Sodium chloride 0.9 Infusion in the VIAFLEX container should be established prior to use. Precautions & Warnings . Caution: Do not store bags containing added medications. Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9.

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