The suitability of the container materials has been established through biological evaluations, which have shown the container passes Class VI U.S. Pharmacopeia (USP) testing for plastic containers. Refer to complete directions accompanying set. When Sodium Chloride 0.9% is used as a diluent for injectable preparations of other drugs, the nature of additives will determine the likelihood of any other undesirable effect. Tell your doctor or nurse as soon as possible if you do not feel well while you are Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container. below 25°C. The following adverse reactions have been reported in the post-marketing experience during use of 0.9% Sodium Chloride Injection, USP and include the following: General disorders and administration site conditions: Infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria. the management of other conditions that are not mentioned above. a. 3. Precautions & Warnings . Your doctor will decide what dose, how often and how long you will receive it. Mostly these are mild d. Prime set and regulate administration as required. Because many drugs are present in human milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing woman. Use in patients with (severe) renal impairment, Sodium Chloride 0.9% should be administered with particular caution to patients with or at risk of severe renal impairment. 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. Fluid balance, serum electrolytes and acid-base balance should be monitored before and during administration, with particular attention to serum sodium in patients with increased non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients co-medicated with vasopressin agonist drugs, due to the risk of hospital acquired hyponatraemia (see sections 4.4, 4.5 and 4.8). These have been characterized as hypotension, pyrexia, tremor, chills, urticaria, rash and pruritus. Appropriate therapeutic countermeasures must be instituted as clinically indicated. General adverse effects of sodium excess are described in section 4.9 Overdose. The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. Suspend container from D-shaped hanger. Your doctor will advise you The relevant and supportive measures should be provided as necessary. possible, please read this leaflet carefully before this medicine is given to you. Additives may be introduced before infusion or during infusion through the re-sealable medication port. 6. d. Discard unit if leaks, particles or cloudiness are evident. Select one or more newsletters to continue. Renal sodium and lithium clearance may be increased during administration of Sodium Chloride 0.9%. Administer immediately following the insertion of infusion set. Do not use it after the expiry date (EXP) printed on the label. if you have any concerns. The available sizes of 0.9% Sodium Chloride Injection, USP are shown below: Exposure of pharmaceutical products to heat should be minimized. with these terms and conditions. Caxton Way, Thetford, Norfolk, IP24 3SE, UK. If use cannot be avoided, monitor serum sodium concentrations. The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy. If use cannot be avoided, monitor patients with severe renal impairment for development of these adverse reactions. Do not administer unless solution is clear, free from visible particles and the seal is intact. 3. The equipment should be primed with the solution in order to prevent air entering the system. Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. breathlessness, which may be severe and usually worsens when lying down, any condition for which you are taking corticosteroids or corticotrophin. They are parenteral solutions containing various concentrations of sodium chloride in water for injection intended for intravenous administration. It is not known whether this drug is present in human milk. The introduction of additives to any solution, regardless of type of container, requires special attention to assure that no incompatibilities result. Prior to infusion, visually inspect the solution for particulate matter and discoloration. Infusion given through slow injection into your veins (this is called an intravenous This information is intended for use by health professionals, Sodium Chloride Intravenous Infusion BP 0.9% w/v, For the full list of excipients, see section 6.1. Hypersensitivity and infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% Sodium Chloride Injection, USP. This rarely happens as Sodium Chloride Injection and Sodium Chloride Intravenous Infusion Additives may be introduced before infusion or during infusion through the injection site. It is the responsibility of the physician to judge the incompatibility of an additive medication with the Sodium Chloride 0.9% Intravenous Infusion solution by checking for eventual colour change and/or eventual precipitate, insoluble complexes or crystals apparition. Sodium Chloride Injection and Sodium Chloride Intravenous Infusion contain sodium Monitoring of serum sodium is particularly important for hypotonic fluids. (eg SIADH or postoperative). attention. 1000ml, 500ml, 250ml, 150ml - the shelf life is 24 months providing the unit has not been opened. A breakaway seal in the tube between the vial adaptor and the container is broken to allow transfer of the diluent into the vial and reconstitution of the drug. Individuals donating for the first time may be predisposed to these symptoms due to psychological factors. Reactions unique to apheresis collection procedures may also occur. Sodium Chloride. Ask your doctor Appropriate therapeutic countermeasures should be instituted as clinically indicated. Sodium Chloride Injection and Sodium Chloride Intravenous Infusion may be used for Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. c. Shake and squeeze the VIAFLEX container so that the solution and medication are thoroughly mixed. Thorough and careful aseptic mixing of any additive is mandatory. Sodium Chloride Injection and Sodium Chloride Intravenous Infusion may also be used Those additives known to be incompatible should not be used. This product must be used with caution in patients with an impaired ability to handle sodium such as organic heart disease especially with a history of congestive heart failure, patients with renal insufficiency, cirrhosis of the liver, cardiopulmonary diseases or patients receiving salt retaining steroids.

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