Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
SODIUM CHLORIDE
TEVA MEDICAL MARKETING LTD.
B05XA03
SOLUTION FOR INFUSION
SODIUM CHLORIDE 450 MG / 100 ML
I.V
Required
TEVA MEDICAL LTD, ISRAEL
SODIUM CHLORIDE
SODIUM CHLORIDE
Supply of water and electrolytes.
2014-06-30
לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה עדימ עדימ עדימ ל ןולעב )תוחיטב ל ןולעב )תוחיטב ל ןולעב )תוחיטב אפור אפור אפור :ךיראת 7102. 01 7 00 תילגנאב רישכת םש : Sodium Chloride 0.45% Injection ושיר רפסמ ם : 041-21-23285-00 םושירה לעב םש : Teva Medical LTD ה טורפל דעוימ הז ספוט דבלב תורמחה ! תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט WARNINGS Hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus may occur with 0.45% Sodium Chloride Injection. Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Depending on the volume and rate of infusion, the intravenous administration, 0.45% Sodium Chloride Injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration/hypervolemia, congested states, pulmonary edema, or acid-base imbalance. The risk of dilutive states is inversely proportional to the electrolyte concentration of the injection. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injection. Monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient or the rate of administration warrants such evaluation. The infusion of solutions with 0.45% Sodium Chloride Injection may result in hyponatremia. Close clinical monitoring may be warranted. Hyponatremia can lead to headache, nausea, seizures, lethargy, coma, cerebral edema and death. The risk for hyponatremia is increased, for example, in children, elderly, women, Baca dokumen lengkapnya
Reference ID: 3676997 ב ודי לע רשואו קדבנ ונכותו תואירבה דרשמ י"ע עבקנ הז ןולע טמרופ - 14.2.2017 0.45%SODIUM CHLORIDE INJECTION SOLUTION FOR INFUSION IN NON PVC BAGS DESCRIPTION 0.45% Sodium Chloride Injection is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5. Composition, osmolarity, and ionic concentration are shown below: 0.45% Sodium Chloride Injection contains 4.5 g/L Sodium Chloride (NaCl) and is hypotonic with an osmolarity of 154 mOsmol/L (calc). It contains 77 mEq/L sodium and 77 mEq/L chloride. The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration. The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication (See DIRECTIONS FOR USE). The primary function of the overwrap is to protect the container from the physical environment. CLINICAL PHARMACOLOGY 0.45% Sodium Chloride Injection has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient. INDICATIONS AND USAGE Sodium Chloride Injection is indicated for supply of water and electrolytes. CONTRAINDICATIONS None known. WARNINGS Hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus may occur with 0.45% Sodium Chloride Injection. Reference ID: 3676997 Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Depending on the volume and rate of infusion, the intravenous administration, 0.45% Sodium Chloride In Baca dokumen lengkapnya